Career Opportunities

Career Opportunities

Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by our goal of improving the lives of people living with cancer. We pursue this goal with a tenacity, focus, and commitment to excellence that defines who we are and how we work.

We seek dedicated, passionate, hardworking, intelligent, thoughtful, and authentic individuals who thrive within a collaborative and fast-paced environment and will bring their experiences, unique perspectives and problem-solving skills to the team. In return, we cultivate an environment that rewards and recognizes hard work and provides opportunities for learning and growth as part of a team making a meaningful difference in the lives of patients.

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Position:
Associate Director, CDx, Regulatory Affairs
Function:
Regulatory Affairs
Location:
Remote
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

The Associate Director, Regulatory, CDx will provide project oversight and regulatory submission support for biomarker and diagnostic technologies for the Loxo Oncology at Lilly pipeline, in addition to supporting program management  for diagnostics projects. Supporting Companion Diagnostic (CDx) development plans, the successful candidate, in collaboration with both Diagnostic (Dx) and Drug (Rx) development teams, will advise on the managing the CDx partners and CROs developing diagnostic assays, coordinating transfer of materials and knowledge as well as collaborating with partners towards timely CDx regulatory submissions in a small fast-paced, dynamic work environment. In addition, he/she will assist/advise in managing the development, outsourcing, and validation of clinically applicable biomarker assays. This function will play a critical role in R&D, with emphasis on later stage diagnostic development associated with Loxo Oncology at Lilly’s programs. This individual must perform with a high degree of independence and will work directly on programs as an  established regulatory expert in CDx development.
Roles and Responsibilities of the Position
  • Responsible for planning and executing meetings with regulatory agencies that include diagnostic partners and internal Dx and Rx teams.
  • Work with Rx regulatory colleagues and diagnostic partners to determine best practices towards development & global registration activities.
  • Evaluate impact of relevant Rx and CDx regulations on Rx and CDx development & registration activities, respectively.
  • Provide project management/oversight towards CDx regulatory deliverables (e.g. SRD, IDE, CDRH pre-subs, PMA, 510(k)), technical feedback on CDx analytical and clinical study plans, regulatory support, strategic guidance and advisement on CDx project teams.
  • Help develop strategies to enable timely registration and approval of diagnostic products by regulatory agencies, synchronizing with the therapeutic development plan.
  • Provide leadership and support interactions with diagnostic partners to mutually align on co-development regulatory needs and expectations for major project tasks like regulatory pre-market approval (e.g. PMA, 510(k), EU technical files and international registration deliverables) submissions.
  • Support team or lead interactions with FDA/CDRH and other health authorities (HA).
  • Generate SRD and CDRH pre-subs as needed to support Rx Clinical Strategies
  • Review and approve key regulatory submissions to CDRH generated by CDx partners.
  • Help with clinical biomarker data and CDx samples in collaboration with the biomarker/biospecimen team.
  • Generate CDx regulatory team meeting schedules, agendas and meeting minutes.
  • Support Dx teams on contracts, budgets, project and development timelines.
  • Maintain knowledge of applicable CDx regulatory requirements and scientific/technical issues relevant to assigned projects.
  • Work with Rx regulatory team members to align all CDx regulatory project activities and deliverables from each functional area.
  • Support the development and maintenance of high level, detailed CDx timelines to assure that the functional timelines are aligned with global program timelines.
  • Bring issues to Manager or Program team’s as necessary and participate in the resolution of delays or potential delays.
  • Manage project team meetings as well as minutes, agendas, action items, etc.
  • Respond to changing duties as responsibilities may vary based on potential pipeline growth, project needs, and stages of development (pre- clinical, clinical or commercial).
Required Qualifications and Background
  • B.S. degree or higher, preferably in a health-related field. Advanced degree strongly preferred.
  • Minimum of 3 years of late stage CDx development and regulatory experience at a diagnostics or pharma company.
  • Prior CDRH pre-submission, SRD, PMA experience required.
  • NGS assay development/regulatory experience preferred.
  • Familiar with regulatory issues and challenges associated with drug/diagnostic co-development and companion diagnostics and documents or guidelines relevant to CDx development/registration.
  • Experience with Japan, China, South Korea CDx registration a plus.
  • Well-developed Regulatory project management execution, communication, and presentation skills.
  • High level of integrity, accuracy, and attention to detail.
  • Self-organized, self-directed, highly motivated with strong critical thinking and analytical skills.
  • Willingness to work collaboratively, think critically, and incorporate diverse perspectives into decision-making.
  • Demonstrated ability to work successfully in a nimble, fast-paced matrixed environment.
  • Outstanding interpersonal, communication and negotiation skills.
  • Demonstrated ability to guide/coach teams to timely achievement of objectives.
Location for this role:
  • Remote (US East Coast based )
Physical Demands / Travel

The demands of this position are consistent with light office duties. This position is required to travel approximately 15%.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is based in a typical office setting.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Associate Director, Clinical Biomarker Development (Multiple Locations)
Function:
Biomarker Operations
Location:
Stamford, CT
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

The Associate Director, Clinical Biomarker Development will integrate biomarker research and clinical development, and will be accountable for the design, delivery, and execution of biomarker and diagnostics plans in early phase clinical programs. Programs include early proof of concept through registrational studies in a variety of targets. The role involves cross functional collaborations across Biomarker Operations, Clinical Development and Translational Medicine as well as Diagnostic Medical Affairs. Responsibilities encompass strategic planning to optimize the clinical and registrational utility of Biomarker development plans for assigned projects as well as management and career development of biomarker scientists. This person must thrive in a fast-paced, team-oriented environment and be adaptable to rapidly changing priorities. 
Roles and Responsibilities of the Position:
  • Oversee the integration of biomarker and diagnostic development plans in clinical development with the current oncology treatment landscape, registrational and launch needs for the asset and with external competitors.
  • Ensure individual biomarker scientist plans are developed and implemented optimally according to the strategic needs of the assets and are aligned to company positions and guidelines.
  • Create  and foster  strong  strategic partnerships with colleagues  that include Biomarker Operations, pre-Clinical Development, Clinical Operations/Development, Dx Regulatory Affairs and Dx Medical Affairs. 
  • Apply Biomarker Development strategy to the design and interpretation of clinical trials.
  • Provide strategic input into data analysis, and engage in critical thinking, to deliver key data generation and interpretation essential for decision making as well as public scientific disclosure.
  • Lead integration with functional teams such as discovery, translational medicine, data science, clinical science etc to ensure timely analysis, interpretation and disclosure of data to support development of our oncology pipeline.
  • Demonstrate substantial and  relevant  knowledge  of  scientific  and  medical literature  with  genomics and biomarker expertise and  its  application to  strategic drug development and registration.
  • Apply scientific  and  operational  knowledge to  identify and analyze  problems and information of considerable complexity and implement effective plans and solutions. Collaborate with operational teams to ensure cohesive planning and strategy.
  • Ability to prioritize  effectively  and  meet multiple deadlines  successfully  with attention to detail, setting high performance standards.
  • Proactively generate ideas for  improvements and  take action to solve problems and achieve goals beyond what is required.
Required Qualifications and Preferred Background:
  • MD or PhD  required along with 7+ years  of  biomarker experience within an academic or industry setting.
  • Strong  preferably within  laboratory-based cancer research or clinical trials is preferred.
  • Clinical trial expertise along with experience in  oncology with drug development highly desirable. 
  • The skills required for success in the job include scientific and analytic ability, ability to  think  strategically  and  tactically,  an  interest  in  applied  clinical research,  an ability  to  work effectively in multifunctional  teams and excellent organizational and communication skills.
  • The candidate must demonstrate proven ability to evaluate,  interpret  and present complex scientific data to both technical and non-technical audiences.
  • Demonstrated ability to work well with other accomplished professionals within and across functions/teams.
Available Locations for this role
  • Stamford, CT
  • South San Francisco, CA
  • US Based-Remote
Physical Demands/ Travel:
 
The physical demands of this job are consistent with an  office  setting.
 
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
 
 
Work Environment:
 
This position’s work environment is office/remote based.
 
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
 

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Associate Director, CMC Regulatory Affairs
Function:
CMC
Location:
Remote
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

·       Responsible for leading the Regulatory CMC function, you will collaborate cross-functionally to develop the regulatory CMC strategy, provide guidance to broader CMC functions, and drive regulatory CMC filing(s).
·       Work collaboratively with senior leadership to develop regulatory CMC strategies for multiple investigational products from first-in-human studies through registration. 
·       Provide regulatory support and guidance to the CMC team (Process Chemistry, Pharmaceutics and Analytical) to ensure all applicable global regulatory CMC requirements are considered and appropriately incorporated into the clinical trial material strategy.
·       Lead the preparation and filing of regulatory CMC submissions and manage the interactions with all Health Authorities for CMC topics.  
·        Provide regulatory CMC support and guidance to various cross-functional teams and ensure all applicable regulatory requirements are considered and appropriately incorporated into clinical and commercial products.
Roles and Responsibilities of the Position
  • Responsible for aiding in the coordination, authorship, preparation, review and timely filing of multiple INDs / IMPDs / NDAs each year
  • Responsible for the maintenance of regulatory submissions (INDs, IMPDs, NDAs, supplements/amendments, annual updates, regulatory briefing documents, and marketing applications to FDA and international regulatory authorities) which support clinical programs, CMC and quality
  • Develops and communicates regulatory CMC strategy, identifying key issues and remediation activities needed throughout project/product life cycle
  • Function as Regulatory Affairs CMC expert on development project team(s). Provides quality/CMC review for clinical study protocols, clinical study reports, investigator brochures and other relevant reports. Establishes strong collaboration/cross functional relationships with Loxo Regulatory Affairs, CMC, QA and Clinical Operations team members and external collaboration partners.  Leads FDA meetings on CMC issues.
  • Lead and strategize with the CMC team to generate and organize responses to queries from health authorizes on CMC documentation submissions.
  • Work in the Loxo Oncology at Lilly Quality System and serve as the Regulatory SME to assess CMC change controls, drug substance and drug product specifications, and clinical labels during development, provide guidance, and plan and execute reporting to health authorities as appropriate.
  • Collaborate with CMC and QA to conduct impact assessments and act as change action owner to ensure updates to Regulatory filings are made and communicated. 
  • Work with external collaboration partners to convert IND sections to IMPD and assess gaps/additions that are required for the IMPD / ex-US filings.
Required Qualifications and Background
  • 8+ years pharmaceutical industry experience and 6+ years in Regulatory Affairs.  Advanced degree in a scientific discipline preferred.
  • Evidence of successful submissions to FDA (e.g., INDs, NDAs, INDs, IMPDs, briefing packages) and demonstrated evidence of writing of regulatory documents.
  • Established working knowledge of regulatory guidelines and regulations (US and international).
  • Regulatory experience supporting both development projects and commercial products.
  • Strong knowledge of eCTD elements and structure and regulatory writing skills.
  • Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
  • Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
  • Strong communication skills both written and oral.
  • Ability to multi-task and shift priorities rapidly to meet tight deadlines.
  • Professional demeanor and an excellent written and verbal communicator.
  • Detail oriented and well organized.
  • Good and thoughtful listener.
  • Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.
  • Proficient in Microsoft Office suite and applications. 
*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Associate Director, Diagnostic Medical Affairs
Function:
Diagnostic Medical Affairs
Location:
Remote
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

The Associate Director, Diagnostic Medical Affairs will provide input to diagnostic strategy and support execution of that strategy for assigned precision medicine product launches. This role has specific focus on identifying unmet medical needs and barriers to adoption of clinical biomarker testing for the program disease states. Strategic planning and execution will include but is not limited to planning educational needs, publication planning, thought leader engagement, and internal cross functional alignment with business unit teams. As part of the Loxo Oncology at Lilly global medical affairs team, the Associate Director will focus on understanding the diagnostic testing environment and building plans to address identified gaps which may impact adoption or utilization of biomarker tests. The Associate Director Medical Affairs may help to inform diagnostic development strategy as well as support launch strategy for biomarker testing. The Associate Medical Director provides expertise to a variety of diagnostic focused tasks and utilizes their expertise in clinical diagnostics and companion diagnostics to establish strong partnerships with internal and external stakeholders. Additionally, the Associate Director will provide cross functional support to address business needs of the development, clinical and commercial teams as it relates to diagnostic testing.
Roles and Responsibilities of the Position
  • Support the development and implementation of the diagnostic Medical Affairs launch strategy for assigned programs.
  • Work closely and in synergy with diagnostic development teams as well as therapeutic medical affairs team.
  • Communicate diagnostic and therapeutic market trends which may impact biomarker testing.
  • Support companion diagnostic development timelines associated with assigned programs.
  • Serve as Loxo Oncology’s scientific representative to the pathology, diagnostic and medical communities; facilitate the appropriate exchange of scientific information.
  • Participate and support advisory boards and steering committees.
  • Provide support through development and/or review of field based diagnostic educational and promotional materials for scientific accuracy.
Required Qualifications and Background
  • MD with formal Training in Anatomic Pathology, American Board of Pathology – Anatomic Pathology eligible or certified; OR PhD with 3+ years’ pathology, in vitro diagnostic development or clinical diagnostic laboratory experience in oncology. 
  • Strong knowledge of pathology laboratory clinical diagnostic testing processes, regulatory oversight, technologies and methods used.
  • Ability to apply diagnostic medical experience and knowledge to business needs.
  • Excellent verbal and written communications. Proficient with evaluating and reporting complex scientific and clinical data and translating them into simple messages. Quick understanding of a disease landscape. 
  • Must have proven experience working in a matrixed environment and be an effective collaborator. 
  • Self-directed and proactive individual with ability to thrive in a fast-paced, entrepreneurial, dynamic environment with high performing colleagues 
  • Comfortable executing on multiple projects independently. 
  • Ability to build strong relationships with co-workers of various backgrounds and expertise.  
  • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor 
  • Excellent interpersonal skills, with the ability to gain respect and influence and to build lasting relationships with internal colleagues as well as external thought leaders within the diagnostics community.
  • Ability to critically review current Dx literature, providing relevance to our products and markets.
  • Planning and organizational ability as well as budget management.
  • Proficient in Microsoft Office suite and applications.
Additional Preferred Qualifications
  • Experience in Hematologic cancer diagnostic tests in pathology
  • Experience with both anatomic and molecular pathology laboratories and test methods
  • Experience and knowledge of IVD and CDx market, regulatory processes and reimbursement
  • Prior direct management experience
  • Experience interacting with pathologists and pathology laboratories
Physical Demands/ Travel:
 
The physical demands of this job are consistent with light office duties. This role requires up to 40% travel primarily to US offices but also with global travel for international business meetings several times per year.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
 
Work Environment:
 
This position’s work environment is in a home office.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Associate Director, Discovery Biology
Function:
Target Discovery
Location:
South San Francisco, CA
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

The Discovery Biology team will be part of a multi-disciplinary effort focused on bringing forward innovative cancer drug therapies. The Discovery Biology Associate Director will be responsible for leading a research team to identify the next generation of molecular targets for cancer therapeutics. Experience in either functional genomics or chemical biology is required. The Associate Director will lead the discovery and early validation of oncology targets through close collaborations with other discovery and translational functions. 
Roles and Responsibilities of the Position
  • Lead cross-functional teams that will be responsible for novel target discovery and validation including Discovery Biology team members in SSF and NYC
  • Supervise and mentor PhD and non-PhD scientists engaged in target identification and validation to think deeply and work creatively while delivering excellent scientific results and insights to the project teams and their colleagues
  • Develop and implement strategies that will enable Discovery Biology team members to continually advance internal drug development efforts through our discovery, clinical and research programs
  • Innovate technologies and methods to advance our discovery projects particularly in the area of gene editing/functional genomics and or chemical biology
  • Engage leaders across Loxo Oncology at Lilly to identify, credential, and advance new targets and serve as a liaison for the Discovery Biology team and the company at large
  • Contribute to due diligence evaluation of external opportunities
  • Mentor post-doctoral fellows
Required Qualifications and Background
  • PhD in systems biology, molecular & cellular biology, chemical biology, or related field
  • Minimum of 5-10 years research experience following post-doctoral training with prior experience in target discovery/credentialing and cancer biology in the biotech or pharma setting
  • Extensive experience in the areas of cancer biology and cancer genomics
  • Demonstrated track record of success in leveraging functional genomics or chemical biology platforms
  • Demonstrated evidence for the ability to partner with computational biologists to leverage systems-scale datasets
  • Expertise in designing and commissioning studies using a variety of research tools in cancer cell lines and murine models of cancer
  • Experience in leading PhD level scientists
  • Outstanding communication, writing, and presentation skills is a must
  • Highly organized with excellent analytical, documentation and multi-tasking skills
  • Provide strategic input to target identification and validation strategy to leadership team
  • Ability to collaborate, lead, and influence others
Additional Preferred Qualifications
  • Hands on experience executing functional genomics screens or deploying chemical biology tools
  • Experience working with external CROs to optimize internal/external resources
Physical Demands/ Travel:
 
The physical demands of this job are consistent with light office duties and some laboratory work. Some light lifting, and maneuvering may be required.
 
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
 
 
Work Environment:
 
This position’s work environment is in an office and laboratory environment.
 
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Associate Director, Discovery Biology
Function:
Target Discovery
Location:
New York, NY
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

The Discovery Biology team will be part of a multi-disciplinary effort focused on bringing forward innovative cancer drug therapies. The Discovery Biology Associate Director will be responsible for leading a research team to identify the next generation of molecular targets for cancer therapeutics. Experience in either functional genomics or chemical biology is required. The Associate Director will lead the discovery and early validation of oncology targets through close collaborations with other discovery and translational functions. 
Roles and Responsibilities of the Position
  • Lead cross-functional teams that will be responsible for novel target discovery and validation including Discovery Biology team members in SSF and NYC
  • Supervise and mentor PhD and non-PhD scientists engaged in target identification and validation to think deeply and work creatively while delivering excellent scientific results and insights to the project teams and their colleagues
  • Develop and implement strategies that will enable Discovery Biology team members to continually advance internal drug development efforts through our discovery, clinical and research programs
  • Innovate technologies and methods to advance our discovery projects particularly in the area of gene editing/functional genomics and or chemical biology
  • Engage leaders across Loxo Oncology at Lilly to identify, credential, and advance new targets and serve as a liaison for the Discovery Biology team and the company at large
  • Contribute to due diligence evaluation of external opportunities
  • Mentor post-doctoral fellows
Required Qualifications and Background
  • PhD in systems biology, molecular & cellular biology, chemical biology, or related field
  • Minimum of 5-10 years research experience following post-doctoral training with prior experience in target discovery/credentialing and cancer biology in the biotech or pharma setting
  • Extensive experience in the areas of cancer biology and cancer genomics
  • Demonstrated track record of success in leveraging functional genomics or chemical biology platforms
  • Demonstrated evidence for the ability to partner with computational biologists to leverage systems-scale datasets
  • Expertise in designing and commissioning studies using a variety of research tools in cancer cell lines and murine models of cancer
  • Experience in leading PhD level scientists
  • Outstanding communication, writing, and presentation skills is a must
  • Highly organized with excellent analytical, documentation and multi-tasking skills
  • Provide strategic input to target identification and validation strategy to leadership team
  • Ability to collaborate, lead, and influence others
Additional Preferred Qualifications
  • Hands on experience executing functional genomics screens or deploying chemical biology tools
  • Experience working with external CROs to optimize internal/external resources
Physical Demands/ Travel:
 
The physical demands of this job are consistent with light office duties and some laboratory work. Some light lifting, and maneuvering may be required.
 
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
 
 
Work Environment:
 
This position’s work environment is in an office and laboratory environment.
 
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Bioinformatics Engineer/Senior Bioinformatics Engineer (Multiple Locations)
Function:
Discovery Bioinformatics
Location:
South San Francisco, CA
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

We are seeking a talented and highly motivated Bioinformatics Engineer to join our Discovery Bioinformatics group. The successful candidate will build informatics solutions using high-performance computing and cloud technology multidimensional clinical and preclinical -omics data. They will provide the engineering leadership to build creative solutions to challenging data problems.

Roles and Responsibilities of the Position
  • The successful candidate will have a flexible, learning mindset to design and deliver scientific databases, create workflows to process and analyze high-dimensional data. This will include development of self-service analytics tools to enable and facilitate the real-time analysis of scientific data within our research community. This position will lead local and off-shore engineering teams to deliver informatics solutions focused on data accessibility, quality, and reproducibility.
Required Qualifications and Background
  • Bachelor’s/Master’s/PhD in computer science, bioinformatics, or equivalent experience
  • 2+ years of software development experience, including experience in computer science, bioinformatics or other applied science
  • Documented track record delivering and deploying large-scale informatics production solutions in the cloud using AWS/Azure and Docker
  • Experience implementing bioinformatics pipelines using scalable cloud solutions. Familiarity with Nextflow, Snakemake, or WDL/Cromwell a plus.
  • Understanding of NGS technology, and downstream -omics data analysis (RNAseq, ATACseq, ChIPseq, etc.).
  • Familiarity with designing, maintaining and implementing relational databases. Experience with NoSQL databases a plus
  • Proficiency in working within a Linux/Unix environment
  • High-level understanding of full-stack web development including implementing RESTful web services with Javascript and related languages
  • Strong scripting abilities using Python, Perl, Go, Javascript or any other related programming language
Available Locations for this role:
  • South SF, CA
  • New York City, NY
  • US Based- Remote
Physical Demands/ Travel:
 
The physical demands of this job are consistent with light office duties.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
 
Work Environment:
 
This position’s work environment is in an office.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Biology Project Manager
Function:
Discovery Small Molecule
Location:
Remote
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

Loxo Oncology at Lilly has an immediate opening for a Project Manager, Biology. The Loxo Oncology at Lilly Drug Discovery team’s mission is to invent life-changing targeted therapies for cancer patient populations that are inadequately treated by existing therapies. To that end, we have built a multi-disciplinary team of dedicated drug discovery scientists who are passionate about driving the science forward to create highly selective drugs for known oncogenic drivers. This position will work closely with scientists across disciplines to ensure the appropriate data related to mechanistic and structural biology discovery research is provided to the team in a timely manner.  The position requires excellent people skills, a positive can-do attitude, and the ability to thrive in a highly interactive, fast-paced, team environment.
Roles and Responsibilities of the Position
  • Coordinate studies and manage deliverables in molecular biology, protein expression, protein purification, and cell line generation at contract research organization and collaborators.
  • Plan meeting agendas, provide minutes, and ensure action items are assigned, tracked, and completed
  • Review incoming data and QC results
  • Work with the team on data interpretation and next steps
  • Plan and manage project deliverables including setting timelines and coordinating shipments
  • Manage Biology activities including but not limited to quote requests, invoices, contracts, agreements, and meeting scheduling
  • Work with the scientific computing team to streamline the process of getting the data into the discovery data base
  • Optimize information distribution and communication to cross-functional teams.
  • Develop and provide consistent project tracking and project reporting
  • Proactively investigate new or different technologies to improve the effectiveness of the drug discovery process. 
Required Qualifications
  • BA/BS/MS in biology, genetics, biochemistry, molecular biology or a related field.
  • Minimum 3+ years project management experience within the pharmaceutical industry
  • Proficient in Microsoft Office suite and other project management tools
Additional Background and Preferences
  • Familiarity in using common scientific software: Snapgene (or similar Mol. Bio software), data visualization and analytics is highly desired.
  • Experience with a variety of cloning technologies and protein expression systems (E.coli, insect cell, mammalian, yeast)
  • Familiarity with FPLC protein purification techniques such as IMAC, SEC, IEX, and protein characterization like Western Blot, Mass spectrometry is highly desired
  • Familiarity with strategies on engineering cell lines to express or knock-down genes of interest and cell line characterization is a plus
  • Enthusiastic, self-motivated, and keen to improve processes and overcome inefficiencies
  • Excellent interpersonal skills with ability to communicate and interact well with colleagues, vendors, contractors, scientific advisors, and staff at all levels
  • Attention to detail and ability to adapt to evolving priorities
  • Highly organized with excellent analytical, documentation, time management, and multi-tasking skills. 
Physical Demands/Travel:

The physical demands of this job are consistent with light office duties.
 
The physical demands here are representative of those that must be met by an employee to successful perform the essential functions of this job.

Work Environment:

This position is a non-lab position but will require working closely with laboratory staff.    
 
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Biostatistician
Function:
Biostatistics
Location:
South San Francisco, CA
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

This position will serve as study statistician for Phase 1-3 oncology studies to support NDA submissions as well as coordinating activities with other functional groups to ensure timeliness and quality of study deliverables. 
Roles and Responsibilities of the Position
  • Assist data management staff in the design of case report forms; review of study database structures, data management plan, edit check specifications, and manual data review listing specifications; write additional data check specifications.
  • Develop and review statistical analysis plans, including the definitions of derived variables, structure and content of analysis datasets, statistical analyses, and the design of templates for statistical tables, figures, and listings for clinical study reports.
  • Direct and conduct statistical analyses and interprets results of analyses for assigned studies. Maintain consistent analytical approaches and reporting formats within and across studies.
  • Understand and utilize SAS as well as other statistical software packages. As needed, write programs to select/retrieve/manipulate/edit/analyze data.
  • Responsible for the accuracy and completeness of statistical analyses conducted for assigned studies. Research and apply new statistical procedures as needed.
  • Prepare statistical summary reports as needed. Write and/or review the statistical sections of protocols and clinical study reports. Review draft protocols and clinical study reports.
  • Document and archive analysis and programming work to ensure a complete audit trail. Create and maintain biostatistics files for each assigned study.
  • Establish and maintain effective working relationships with vendors and study teams, including data management personnel, statistical programmers, clinical research personnel and corporate partners.
  • Participate in study meetings as needed.
Required Qualifications and Background
  • MS or PhD in Statistics/Biostatistics or related field with 0-2 (with PhD) or 1-3 (with MS) years of experience in biotech/pharmaceutical industry or medical research setting as a statistician or statistical analyst
  • Oncology experience is highly preferred
  • Ability to work effectively in a cross-functional team setting
  • Able to collaborate effectively with internal and external study teams to meet project timelines.
  • Good interpersonal and project management skills are essential.
  • Excellent written and oral communication skills
Physical Demands / Travel

The physical demands of this job are consistent with light office duties.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Clinical Contracts Manager (Multiple Locations)
Function:
Clinical Operations
Location:
South San Francisco, CA
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

The Clinical Contracts Manager is responsible for managing all aspects of vendor selection / contracting, site contracting, and negotiation / execution of other required agreements (e.g. LOIs) in support of the clinical development plan. This role requires the ability to solve complex problems that require ingenuity, innovation, and creativity as well as experience working with clinical research phases I-IV.  The ability to collaborate with other clinical contracts team members, clinical trial teams, investigational sites and vendors is imperative. 

Roles and Responsibilities of the Position
  • Collaborate with clinical trial teams and other internal stakeholders, vendors and investigational sites to support timely study start-up to meet departmental and organizational goals.
  • Key vendor selection and contracting responsibilities include:
  • Develop study level budget based on CRO benchmark data
  • Manage the formulation of request for information (RFI) and request for proposals (RFP) for clinical services including bidding process
  • Contract and budget negotiation
  • Manage the development and execution of Vendor Master Agreements and Scope of Work (SOWs)
  • PO generation and management
  • Ongoing contract management (e.g. spend, change orders)
  • Key site contracting responsibilities include:
  • Develop patient/site level budget templates based on benchmark data
  • Manage the development and execution of Master Clinical Trial Agreements (MCTAs) and Clinical Trial Agreements (CTAs)
  • Ongoing contract management (e.g. amendments) 
  • Manage the development and execution of other agreements as needed.
  • When required, act as liaison between clinical service groups (SMO, CRO), legal and clinical trial teams for outsourced trials.
  • Manage the negotiation efforts to resolve complex and “deal breaker” issues with external parties.
  • Develop contract concepts and techniques and solve complex contractual problems that require ingenuity, innovation, and creativity.  
Required Qualifications and Background
  • BS degree in business administration, finance, science or related field or equivalent on the job experience may be considered; advanced degree a plus.
  • Minimum 3-5 years of experience in pharmaceutical services with 2+ years of contract management and/or study start-up activities including contract negotiations and management
  • High degree of organizational, analytical, and team management skills.
  • Ability to handle complex budgets.
  • Computer literacy with document and spreadsheet applications.
  • Ability to work on complex, multi-faceted projects.
  • Proven negotiation skills and vast knowledge of clinical trial agreements. 
  • Demonstrated ability to work well with other accomplished professionals within and across functions/teams; Strong collaborator.
  • Strong communication skills both written and oral.
  • Ability to multi-task and shift priorities rapidly to meet tight deadlines.
  • Professional demeanor.
  • Detail oriented and well organized.
  • Good and thoughtful listener.
  • Enthusiastic, self-motivated and keen to improve processes and overcome any inefficiencies.
  • Proficient in Microsoft Office suite and applications.
Available locations for this role:
  • Stamford, CT
  • South San Francisco, CA
  • US Based-Remote
Physical Demands/ Travel:
 
The physical demands of this job are consistent with light office duties.
 
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
 
 
Work Environment:
 
This position’s work environment is in an office.  
 
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Clinical Data Specialist/Senior Clinical Data Specialist (Multiple Locations)
Function:
Clinical Data Management
Location:
Remote
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

The Data Management Support position is responsible for performing clinical data management tasks from study start-up through eTMF archiving as directed by the study Lead Data Manager (LDM). This individual collaborates with the cross-functional study team to develop Sponsor clinical data review listings,  perform Sponsor Data Manager data review/cleaning, post and QC data transfers to and from Loxo, generate and report on study data metrics, and draft the Sponsor Data Management Plans for LDM review. The Data Management Support position ensures all actions are in full compliance with Loxo standard operating procedures (SOP) and regulatory agency guidelines. 
Roles and Responsibilities of the Position
  • Assists the Sponsor LDM to provide day to day support of Data Management (DM) services, including but not limited to the following tasks.
  • Partners with Contract Research Organization (CRO) DM for tracking and reporting on vendor data completeness and cleanliness.
  • Generates and distributes study data metric reports and data review listings which may include Excel pivot tables, algorithms, or VLOOKUP.
  • May be requested to perform oversight of vendor data including timeline development, PowerPoint slide development and presentation, and data trends reporting.
  • Communicate complex issues clearly through multiple media methods including email, instant message, text, telephone, and video phone.
  • May develop low-complexity data listings from Electronic Data Capture (EDC), JReview, or other reporting tool.
  • Drafts specifications for medium to high-complexity listings and reports.
  • Performs data review as directed by the LDM.
  • Vendor data transfer management
  • Drafts Sponsor DM documents such as Data Transfer Specifications (DTS), Data Management Plan (DMP), EDC design specifications, edit check specifications (ECS), Data Snapshot Requirements Plan, et al.
  • Performs Sponsor DM review of CRO generated Data Management documents such as:  CRF completion guidelines, DMP, data reconciliation plans, ECS or any other document as assigned by the LDM.
  • Performs Sponsor user acceptance testing (UAT) of EDC, reports, listings, data integrations, et al.
  • Works in partnership with CRO and DM Vendor representatives to ensure DM services timelines are transparent and on-track.
  • Attends internal, vendor, and CRO meetings as directed by the LDM.
  • Performs any and all other tasks and activities as requested.
Required Qualifications and Background
  • Bachelor’s degree in life sciences, math, computer science or related field required.
  • Minimum of two years’ clinical data management experience. 
  • Oncology research experience is preferred.
  • Proficiency in MS Office (Outlook, Word, Excel, PowerPoint)
  • Experience in MS Project is preferred.
  • Experience with web-based EDC, clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug.
  • Experience with Veeva EDC is preferred.
  • Excellent time management skills and a proven ability to work on multiple projects at any given time in a fast-paced environment.
  • Available to assist the study team to achieve important data deliverables across Pacific and Eastern Time Zone.
  • Self-driven and high achieving while maintaining a focus on quality in all aspects of work.
Available locations for this role
  • Stamford, CT
  • South San Francisco, CA
  • US Based-Remote
Physical Demands / Travel

The physical demands of this job are consistent with light office duties. This position will travel occasionally; the average travel for this position is infrequent (<10%) with some variation based upon the demands of the business imperatives.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in the employee’s home office.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Clinical Research Associate/Sr. Clinical Research Associate (Multiple Locations)
Function:
Clinical Operations
Location:
Remote
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

The Clinical Research Associate / Senior CRA in collaboration with the Clinical Trial Manager and/or other operational leadership, contributes to the operational execution of clinical studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities’ regulations/guidelines, and applicable SOPs/WPs.  Responsibilities may include participation on one or more cross-functional study team(s) and/or performance and quality oversight of Contract Research Organization (CRO) teams and other vendors.
 
 
Roles and Responsibilities of the Position
  • Provide operational input on development, management and maintenance of study deliverables [i.e. timelines, study plans, documents, etc.] through collaboration with internal and external stakeholders.
  • Contribute to deliverables within study, drive to solutions across a multi-functional study team.
  • Anticipate and resolve key technical operational problems with multi-functional study team; evaluate and determine issues that require escalation.
  • Use performance metrics and quality indicators to assist with driving study execution.
  • Manage the monitoring visit report review process in order to maintain oversight of clinical monitoring quality and adherence to protocol and established processes and plans.
  • Support Health Authority inspections and CQA audits as required. 
  • Ensure completeness & accuracy of the required data in study management tools including clinical trial management systems, patient enrollment forecasting, etc.
  • Provide proactive identification of potential risks and development/implementation of actions to avoid or mitigate.
  • Develop and maintain collaborative relationships with internal and external partners/stakeholders including both vendors and investigational sites.
  • Collaborate with vendors and other study team members regarding study specific issues and follow through to resolution.
  • Assist in the creation and review of study documents, including but not limited to the Protocol, Informed Consent Form (ICF) and other patient facing materials and assist in updating these study documents as needed.  The CRA may have opportunities to lead creation/updates/review of study documents, as agreed upon with assigned Clinical Trial Manager or Clinical Operations leadership.
  • Participate in vendor specification development and management/oversight.  Vendor oversight activities may include responsibility for specific tasks associated with oversight (ie, review of monitoring visit reports generated by CRO) or may opportunities to lead the overall management of a specific vendor (ie, travel vendor), as agreed upon with assigned Clinical Trial Manager or Clinical Operations leadership.
  • Management of TMF set-up, ongoing quality review, and final reconciliation.
  • In conjunction with Drug Supply Management, manage shipment and reconciliation of Investigational Product (IP) at study and site level as needed.
  • Liaise as needed with CRO and investigative sites to ensure clinical trial data is captured and resolved as required.
  • Contribute to data review/cleaning of clinical data as needed and as defined by study plans.
  • Actively contribute during study meetings including presenting as a subject matter expert as well as generating and distributing study team agendas and meeting minutes.
  • Contribute to development / coordination of study training and study training materials for study team, investigational sites, and vendors. 
  • Contribute to oversight of the required country regulatory (e.g. CTA, MoH) and country/site IRB/IEC submissions/approvals/notifications.
  • Assist with the collection of various study documents such as country/site insurance, CSR appendices, etc.
  • Assist with Investigator Meeting coordination and planning.
  • In addition to all activities listed, Senior CRAs must be able to manage larger, more complex deliverables within a clinical trial with minimal oversight.
Required Qualifications and Background
  • BA/BS Degree in a relevant discipline with 2-4 years’ experience in the clinical trial environment required (inclusive of site level or other relevant experience) for Clinical Research Associate level; direct sponsor and/or CRO experience or 5+ years relevant non-sponsor or CRO experience required for Senior CRA level.
  • Knowledge of ICH/GCP and regulatory guidelines/directives.
  • Demonstrates analytical approach and anticipation of problems.
  • Identifies gaps and provides constructive feedback and solutions.
  • Ability to multi-task effectively and prioritize assignments from multiple sources.
  • Excellent organizational skills.
  • Strong communication skills, both written and oral; proficiency in English.
  • Strong knowledge of MS applications including (but not limited to) MS Project, Word, Excel, PowerPoint.
  • Knowledge of study tools including electronic system skills such as CTMS/ EDC/ IRT/ eTMF.
  • Knowledge of drug development process. Proactively shares information, ideas, input, and/or expertise with team members. Demonstrates concern for high quality outcomes.
  • Responds flexibly to changing business demands and opportunities, proactively looking for ways to contribute.
Available locations for this role:
  • Stamford, CT
  • South San Francisco, CA
  • US Based-Remote
Physical Demands/ Travel:
 
The physical demands of this job are consistent with light office duties. Up to 25% travel may be required.
 
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
 
 
Work Environment:
 
This position’s work environment is in an office.
 
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
 



*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Clinical Trial Manager/Senior Clinical Trial Manager (Multiple Locations)
Function:
Clinical Operations
Location:
South San Francisco, CA
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

The Clinical Trial Manager / Senior Clinical Trial Manager will manage one (or more) clinical studies including leading the planning, organization, and coordination of all operational aspects of the clinical study from protocol development through database lock / study closure;  ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities’ regulations/guidelines, and applicable SOPs/WPs; Provide operational leadership on cross-functional study team(s) and performance and quality oversight of Contract Research Organization (CRO) teams and other vendors.
Roles and Responsibilities of the Position
  • Provide operational leadership on development, management and maintenance of study deliverables [i.e. timelines, study plans, documents, etc.] through collaboration with internal and external stakeholders.
  • Lead and manage the execution of clinical trials, drive to solutions across a multi-functional study team.
  • Anticipate and resolve complex and key technical, operational or business problems with multi-functional study team; evaluate and determine issues that require escalation.
  • Use performance metrics and quality indicators to drive study execution.
  • Support Health Authority inspections and CQA audits as required, including driving inspection/audit readiness through life of study. 
  • Manage study team and/or CRO to ensure completeness & accuracy of the required data in study management tools including clinical trial management systems, patient enrollment forecasting, etc.
  • Proactively identify potential risks and lead the development/implementation of actions to avoid or mitigate; identify points for escalation.
  • Develop and maintain collaborative relationships with internal and external partners/stakeholders including both vendors and investigational sites.
  • Collaborate with vendors and other study team members regarding study specific issues; drive team through issue resolution.
  • Lead and/or collaborate in the creation and review of study documents, including but not limited to the Protocol, Informed Consent Form (ICF) and other patient facing materials, case report forms, and clinical study reports. Manage completion of these deliverables to ensure timelines are upheld. Ensure study documents are updated as needed throughout the trial.
  • Partner with internal contracts management to ensure review, finalization, and escalation as needed of site contracts and budgets.
  • Plan site and country identification and selection in collaboration with internal partners.
  • As appropriate per vendor/scope of work, manage and/or participate in vendor selection, specification development and management/oversight. 
  • Ensure management of the TMF set-up, ongoing quality review, and final reconciliation.
  • Liaise as needed with CRO and investigative sites to ensure clinical trial data is captured and resolved as required.
  • Contribute to data review/cleaning of clinical data as needed and as defined by study plans.
  • Lead study meetings including presenting as a subject matter expert as needed, ensuring agenda and meeting minutes are generated and distributed as needed.
  • Manage the development/coordination of study training and study training materials for study team, investigational sites, and vendors. 
  • Contribute to oversight of the required country regulatory (e.g. CTA, MoH) and country/site IRB/IEC submissions/approvals/notifications.
  • Ensure the collection of various study documents such as country/site insurance, CSR appendices, etc. is completed as needed.
  • Manage Investigator Meeting coordination and planning.
  • Lead and assist in training other Clinical Operations roles (e.g. CRAs).
  • In addition to all activities listed, Senior Clinical Trial Managers must be able to manage large, complex trials and/or manage multiple ongoing studies simultaneously with minimal oversight.
Required Qualifications and Background
  • BA/BS degree in a relevant discipline with 5+ years’ experience in clinical drug development required at Clinical Trial Manager level; 6+ years’ experience required for Senior Clinical Trial Manager level.
  • For oncology studies: Oncology and/or Hematology experience preferred; for clinical pharmacology studies: Clinical Pharmacology/Healthy Volunteer experience preferred
  • Experience in managing global clinical trials preferred.
  • Experience with managing clinical research budgets.
  • Knowledge of ICH/GCP and regulatory guidelines/directives.
  • Experience with managing a multi-functional team, including leadership skills and driving deliverables.
  • Demonstrates analytical approach and anticipation of problems.
  • Identifies gaps and provides constructive feedback and solutions.
  • Follows issues to resolution and escalates as appropriate.
  • Ability to multi-task effectively and prioritize assignments from multiple sources.
  • Excellent organizational skills.
  • Strong communication skills, both written and oral; proficiency in English.
  • Strong knowledge of MS applications including (but not limited to) MS Project, Word, Excel, PowerPoint.
  • Knowledge of study tools including electronic system skills such as CTMS/ EDC/ IRT/ eTMF.
  • Knowledge of drug development process. Proactively shares information, ideas, input, and/or expertise with team members. Demonstrates concern for high quality outcomes.
  • Responds flexibly to changing business demands and opportunities, proactively looking for ways to contribute.
Available locations for this role:
  • Stamford, CT
  • South San Francisco, CA
  • US Based-Remote
Physical Demands/ Travel:
 
The physical demands of this job are consistent with light office duties. Up to 15% travel may be required.
 
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
 
Work Environment:
 
This position’s work environment is in an office.
 
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.


*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Computational Biologist (Multiple Locations)
Function:
Discovery Bioinformatics
Location:
South San Francisco, CA
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

We are seeking a talented and highly motivated Computational Biologist to join our Discovery Bioinformatics group. The successful candidate will work closely with a multi-disciplinary team to rapidly advance small molecule drug development efforts. This position is expected to develop and validate data-driven hypotheses to advance transformative medicines.
Roles and Responsibilities of the Position
  • The successful candidate will work in a face-paced and highly collaborative environment to tackle important questions in oncology drug development. They will employ the latest genomics and statistical approaches to interrogate these questions. Success critically depends on an ability to effectively present complex analyses and results in a clear and concise manner to a diverse audience of scientists.
Required Qualifications and Background
  • MS/PhD in Bioinformatics, Biostatistics, Computational Biology, or similar area of study. Alternatively, post-graduate training in high-dimensional data analyses, supported by scientific achievements (eg., publications, patents, etc), would also be considered equivalent.
  • Relevant experience must be supported by scientific accomplishments such as publications, scientific presentations, patents, etc.
  • Strong understanding of relevant concepts in cancer biology and molecular biology.
  • Hands-on experience with data analysis involving high-throughput molecular assays such as DNA/RNA-Seq, ATAC/ChIP-Seq, single-cell technologies, etc.
  • Understanding of current best-practices for high-throughput genomics/molecular data analyses and their underlying statistical principles.
  • Experience using programming languages such as R, Python, or similar for statistical analysis.
Available Locations for this role
  • South SF, CA
  • New York City, NY
  • US Based- Remote
Physical Demands / Travel:

The physical demands of this job are consistent with light office duties.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment:

This position’s work environment is in an office.  

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Computational Chemist (Multiple Locations)
Function:
Discovery Small Molecule
Location:
San Diego, CA
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

The Loxo Oncology at Lilly Discovery group’s mission is to invent and advance life-changing oncology drugs for cancer patient populations that are poorly treated by existing therapies. To that end, we are building a multi-disciplinary team of dedicated discovery scientists that are passionate about driving the science forward to create and advance highly selective drugs for known oncogenic drivers. We are currently looking for a computational chemist who enjoys tackling cutting edge drug discovery problems and is well versed in the effective use of all current computational techniques and tools. The ideal candidate will be passionate about working with scientists across disciplines to invent and advance novel approaches to drug discovery. The position requires excellent people skills, a positive can-do attitude and the ability to thrive in a highly interactive, fast-paced, team environment.
Roles and Responsibilities for the Position
  • Work closely with our multidisciplinary group on structure-based and ligand-based design and optimization of small molecule oncology drugs.
  • Enable team success by employing a range of modern computational techniques including Quantitative Structural Activity Relationship (QSAR) models, homology modeling, molecular dynamics simulations, multivariate analysis, and in silico predictive models.
  • Provide computational chemistry insight for new target identification and evaluation initiatives in the oncology space across a range of target and binding mode types.
  • Catalyze new hit and lead discovery leaning computation insight to selection of screening collections, database mining and interpretation of results and virtual screening techniques.
  • Work with on-site IT staff to administer and maintain the necessary hardware, software and other computational infrastructure to enable state of the art computational impact on oncology research programs.
  • Proactively investigate new or different technologies to improve the effectiveness of the team.
  • Contribute to the overall strategic thinking for the discovery organization.
Required Qualifications and Background
  • Ph.D. in Chemistry or related field.
  • Experience in small molecule drug discovery across a range of target types, approaches, and drug discovery strategies in a biotechnology or pharmaceutical setting is preferred.
  • Possess a working understanding of medicinal chemistry, in vitro and in vivo ADME, and couple that with modeling-driven approaches that extend to aspects of lead optimization beyond potency.
  • Forward thinking in terms of applying modern computational approaches to current scientific challenges. Apprised of the latest scientific breakthroughs in computational chemistry and ability to apply those techniques to good effect.
  • The ideal candidate will be a key thought leader on the team with a passion for bringing creative approaches to solve challenging problems.
  • Excellent interpersonal skills with ability to communicate effectively with a multidisciplinary team, the LOXO executive team, and outside collaborators. The ability to lead the team in prioritization of activities and programs.
  • Ability to multi-task and shift priorities rapidly to meet tight deadlines.
  • Proficient in Microsoft Office suite and applications.
Available Locations for this Role:
  • Boulder, CO
  • San Diego, CA

Physical Demands / Travel

The physical demands of this job are consistent with lab environment.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in a lab.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Contracts Specialist, Data Management (Multiple Locations)
Function:
Clinical Operations
Location:
Stamford, CT
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

The Data Management Contracts Specialist will help support the negotiation and finalization of master agreements, general services agreements, consultancy agreements, lab services, and any other DM vendor partner.  This role requires the ability to solve complex problems that require ingenuity, innovation, and creativity as well as experience working with clinical research phases I-IV.  The ability to collaborate with other clinical contracts team members, clinical trial teams, study start-up groups and vendors to verify and develop budget and negotiate cost savings is imperative. 
Roles and Responsibilities of the Position
  • Support the negotiation and execution of agreements and budgets including but not limited to master agreements, clinical trial agreements, general services agreements and amendments.
  • Collaborate with clinical contract team, clinical trial teams and other internal stakeholders, study start-up groups, investigational sites, and vendors to support the delivery of fully executed contracts in support of timely study start-up to meet departmental and organizational goal to meet departmental and organizational goals.
  • Assist with the formulation of request for proposals (RFP) for DM services including bidding process and scope of work (SOW).
  • Assist with the formulation of request for information (RFI) for DM services.
  • When required, act as liaison between clinical service groups (SMO, CRO), legal and clinical trial teams for outsourced trials.
  • Contribute to negotiation efforts to resolve complex and “deal breaker” issues with external parties.
  • Support the development of contract concepts and techniques and solves complex contractual problems that require ingenuity, innovation, and creativity. 
Required Qualifications and Background
  • BS degree in business administration, finance, science or related field or equivalent on the job experience may be considered; advanced degree a plus.
  • Minimum 3-5 years of experience in pharmaceutical services with 2+ years of contract management and/or study start-up activities including contract negotiations and management.
  • High degree of organizational, analytical, and team management skills.
  • Ability to handle complex budgets.
  • Computer literacy with document and spreadsheet applications.
  • Ability to work on complex, multi-faceted projects.
  • Proven negotiation skills and vast knowledge of clinical trial agreements. 
  • Demonstrated ability to work well with other accomplished professionals within and across functions/teams; Strong collaborator.
  • Strong communication skills both written and oral.
  • Ability to multi-task and shift priorities rapidly to meet tight deadlines.
  • Professional demeanor.
  • Detail oriented and well organized.
  • Good and thoughtful listener.
  • Enthusiastic, self-motivated and keen to improve processes and overcome any inefficiencies.
  • Proficient in Microsoft Office suite and applications.
Available locations for this role:
  • Stamford, CT
  • South San Francisco, CA
  • US Based-Remote
Physical Demands/ Travel:
 
The physical demands of this job are consistent with light office duties.
 
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
 
 
Work Environment:
 
This position’s work environment is in an office.  

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.
 

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Data Manager, Clinical & Biomarker Data Management (Multiple Locations)
Function:
Clinical Data Management
Location:
Remote
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

This position is uniquely situated to support the Clinical Data Management (DM) team as well as the Biomarker Operations (BMO) team. Clinical DM responsibilities include managing the data flow and transfers for clinical and biomarker data received or distributed by Loxo Oncology at Lilly. This individual will also work with all study DM teams in the creation, validation and distribution of clinical data review and data reporting listings. This position will work collaboratively with the BMO team to facilitate the data transfers of biomarker data from various labs, and also support diagnostic development data activities This individual will ensure that all operations activities stay within full compliance of Loxo Oncology at Lilly regulatory and legal policies.
Roles and Responsibilities of the Position
  • Create, execute and/or distribute data management metrics, listings, and reports, as required.
  • Receive, review the quality, and organize biomarker data and incorporate information into internal or external databases as needed.
  • Develop and update current data transfer specifications by gathering input from biomarker scientists to ensure consistent data transfers.
  • Coordinate data requirements with reference labs to ensure data collection are accurate and formatted appropriately for Data Transfer Specification.
  • Author, manage and track all Data Transfer Specifications for DM and BMO.
  • Perform import QC on all data transfers for DM and BMO.
  • Collaborate with study teams to oversee CRO/service providers for all clinical data transfer and biomarker data needs.
  • Coordinate data transfers with diagnostic development partners as needed.
  • Seek means of improving processes to reduce cycle time, increase accuracy, and decrease work effort.
  • Perform any and all other tasks and activities as requested.
Required Qualifications and Background:
  • Bachelor’s degree in life sciences, math, computer science or related field required.
  • 5+ years’ clinical development experience.
  • Knowledge of industry standards (CDISC, SDTM, ADaM, CDASH).
  • Laboratory background and/or working knowledge of commonly tested biomarkers in the oncology setting, with latest and advanced analytical tool and assay experience preferred.
  • Previous LIMS (Laboratory Information Management System) experience and working knowledge of the clinical drug development process.
  • Prior experience with data transfers or management for CDx or diagnostic developments programs in general is a plus Experience with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug.
  • Excellent verbal/written communication and interpersonal skills and ability to collaborate effectively with cross-functional teams.
  • Proven ability to work both independently and in a team setting.
  • Excellent time management skills and a proven ability to work on multiple projects at any given time in a fast-paced environment.
  • Demonstrated ability to stay abreast of trends and new information in the profession. Demonstrated leadership and project management skills.
  • Good working knowledge of ICH, FDA, and GCP regulations and guidelines.
  • Strong well-rounded technical skills (MS Office; MS Word, Excel, PowerPoint).
Additional Preferred Qualifications
  • 5+ years prior oncology/hematology experience highly desirable.
  • 4+ years of Sponsor experience.
Available Locations for this role:
  • Stamford, CT
  • South San Francisco, CA
  • US Based-Remote
Physical Demands / Travel

The physical demands of this job are consistent with light office duties.  This position will travel rarely; the average travel for this position is 0-10% with some variation based upon the demands of the business imperatives.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office setting.  

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Director, Regulatory Affairs
Function:
Regulatory Affairs
Location:
Remote
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

The Director, Regulatory Affairs will contribute to the formulation of regulatory strategy, serve as the regulatory lead on relevant project teams, and act as the regulatory contact for US/Global health authorities as required.  This individual will oversee the planning and execution of major submissions and responses to regulatory authorities related to IND/NDA submissions, Annual Reports, Investigator Brochures, IND amendments, briefing book for FDA meetings, as well as responses to requests.  
Roles and Responsibilities of the Position
  • Responsible for developing and implementing the regulatory strategy for assigned projects and programs for projects in all stages of development (IND through NDA/BLA approval).
  • Applies global regulatory knowledge governing responsible products to contribute to the overall development strategy.
  • Provide regulatory leadership & guidance to project teams.
  • Lead FDA meetings; develops briefing packages for meetings with FDA and other global health authorities.
  • Responsible for coordinating all aspects of regulatory submissions relevant to assigned projects or programs.
  • Develop response strategies and submissions to regulators.
  • Develop regulatory submission documents. Manage or delegate the management of the completion of documents and other assigned tasks within established timelines and with high quality – in terms of scientific content, organization, clarity, accuracy, format, consistency and adherence to regulatory guidelines, styles and processes.
  • Develop strategies and drafts and/or review responses and other documents intended for submission to FDA and other global health authorities.
  • Identify and assess regulatory risks for assigned projects or programs.
  • Prepare and deliver effective presentations for external and internal audiences.
  • Monitor newly published FDA guidelines and international guidance documents in the context of new and ongoing development programs.
  • Primary point of contact to regulatory agencies relevant to assigned projects or programs, as appropriate.
Required Qualifications and Background
  • 10+ years pharmaceutical/biotech drug development experience and 8+ years in Regulatory Affairs.  Advanced degree in a scientific discipline preferred.
  • Experience in successful submission of INDs/CTAs required, NDA/BLA/MAA submission experience preferred.
  • Proven experience navigating successful submissions in the oncology space is preferred.
  • Strong scientific foundation, including a good understanding of oncology.
  • Knowledge and understanding of global regulatory requirements.
  • Self-motivated in accelerating work to meet challenging timelines.
  • Ability to work both independently with minimal direction and within project teams, committees, corporate partners, etc. to attain group goals.
  • Demonstrate excellent communication skills.
  • Ability to represent the group in project teams.
  • Demonstrate strong organizational skills, including the ability to prioritize tasks.
  • Experience in interfacing with relevant regulatory authorities.
  • Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
  • Experience in interpretation and application of regulations, guidelines, policy statements, etc.
Physical Demands/ Travel:
 
The physical demands of this job are consistent with light office duties. Travel < 10%.
 
 
Work Environment:
 
This position’s work environment is in an office and/or remote.
 
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
DMPK/ADME/BAPK Associate Scientist/Scientist/Sr Scientist
Function:
Discovery Small Molecule
Location:
Boulder, CO
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.
Roles and Responsibilities for the Position
  • Design and execute preclinical studies to understand the pharmacokinetics (PK) and absorption, metabolism, distribution and excretion ADME of drug candidates.
  • Participate in the management of CROs in the conduct of in vitro and in vivo ADME studies
  • Analyze in vitro and in vivo sample utilizing LC-MS/MS
  • Perform non-compartmental pharmacokinetic analysis on data
  • QC in vivo protocols and study reports
  • Collate data and present to program team
  • Contribute to authoring and review of regulatory reports and documents
  • Maintain accurate and timely electronic lab notebook
  • Work effectively both independently and in a team environment
Required Qualifications and Background
  • BS or MS degree in chemistry, biochemistry or related discipline
  • 2-6 years of experience laboratory experience
  • 1+ year LC-MS/MS experience (Sciex systems preferred)
  • Experience with bioanalysis method and assay development
  • Good written and oral presentation capabilities
  • Must have experience with pharmacokinetic modeling

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Drug Safety Physician
Function:
Drug Safety
Location:
Remote
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

The Drug Safety Physician will lead and support the expansion of clinical development programs (or one large, complex program) in support of the overall product development plan with a focus on development of the safety profile. This physician will serve as an ambassador and resource to various physicians and clinical trial sites, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, Loxo Oncology at Lilly customers, markets, business operations, and emerging issues, and perform other responsibilities as requested.
Roles and Responsibilities of the Position
  • Primary responsibility for daily safety case review and will contribute to the design, analysis, interpretation, and reporting of safety findings within a program and will review and contribute to the content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents.
  • Primary responsibility for reviewing safety data periodically and on an ongoing basis to ensure quality control (QC) as required by program needs.   
  • May participate in or lead review of protocol deviations (PD) which may impact patient safety as required by program needs.
  • May participate in, or lead safety development contributions to, due diligence or other business development activity.  As required by program needs, contributes in partnership with research colleagues to design and implement translational strategies.
  • Actively solicits opinion leader interactions related to the disease area(s); partners with Clinical leads, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Safety Development Plans and protocols as appropriate.
  • Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic and safety area. May represent Loxo at key external meetings.
  • Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. May serve as a safety representative for key regulatory discussions.
  • Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures, organization policies and to all other quality standards in conducting research. 
Required Qualifications and Background
  • MD, Board certified or eligible; PhD advantageous.
  • At least 2 years of oncology experience strongly preferred.
  • Ability to exercise judgment and address complex problems and create solutions for one or more projects.
  • Ability to develop collaborative working relationships with physicians, expert consultants, and contracted vendors.
  • Strong analytical mind and problem-solving skills, attention to detail, strong organizational skills, and ability to work independently and as part of a team.
  • Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be able to lead through influence.
  • Proven ability to interact externally and internally to support a global scientific and business strategy.
  • Excellent English written and verbal communication skills. Strong document management skills, including proficiency with MS Word, EndNote, PowerPoint and Excel.
  • Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
  • Strong communication skills both written and oral.
  • Ability to multi-task and shift priorities rapidly to meet tight deadlines.
  • Professional demeanor and appearance and an excellent written and verbal communicator.
  • Good and thoughtful listener.
  • Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.
Physical Demands / Travel

The physical demands of this job are consistent with light office duties. This role will require 10-20% travel.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s primary work environment is in an office / traveling in the field to both US and International locations as indicated.  

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Drug Safety Specialist
Function:
Drug Safety
Location:
South San Francisco, CA
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

The Drug Safety Specialist will be responsible for providing Drug Safety/Pharmacovigilance support for new and ongoing clinical trials including the collection, processing, and reporting of adverse events/endpoints while adhering to International Council for Harmonization (ICH) guidelines, Good Clinical Practices (GCP), applicable regulatory guidelines, data protection guidelines and study procedures. 
Roles and Responsibilities
  • Perform triage of incoming Serious Adverse Event (SAE) reports and consider assessments of seriousness, listedness, and causality; coordinate triage review with medical monitor.   
  • Review case narratives, including identifying relevant information from source documents and write/review queries when additional information needed 
  • Review data entry of SAEs in safety database including MedDRA coding
  • Coordinate medical monitor case review
  • Assist with the management of case processing deadlines
  • Assist in reconciliation between the safety and clinical databases for serious adverse events.
  • Compile safety information for aggregate safety reports and other safety related reports.
  • Assist with ongoing safety surveillance
  • Assist with compilation and updating of safety related spreadsheets including metrics and SUSAR submissions
  • Review and update existing standard operating procedures (SOPs) and assist with creation of new SOPs for safety department as indicated  
  • May oversee work performed by a safety Contract Research Organization (CRO)
Required Qualifications and Background
  • RN, BSN or pharmacy degree with at least 3-5 years of industry experience in Clinical Trial Safety; industry experience from CRO or pharmaceutical/biotech setting will be considered.
  • Previous experience in Health care is strongly preferred
  • Hands on experience with SAE case processing including narrative and analysis of similar event (AOSE) writing, and safety report generation.
  • Working knowledge of MedDRA and WHODrug and FDA safety regulations, ICH guidelines, and global safety regulations.
  • Hands on experience with global safety database(s); experience with Argus strongly preferred.
  • Demonstrated ability to work well with other accomplished professionals within and across functions/teams.
  • Willing collaborator with strong written and oral communication skills.
  • Ability to multi-task and shift priorities rapidly to meet tight deadlines.
  • Detail oriented and well organized.
  • Self-motivated and keen to improve processes and overcome inefficiencies.
  • Proficient in Microsoft Office suite and applications.
*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Lab Operations Manager, Discovery Biology (Multiple Locations)
Function:
Target Discovery
Location:
South San Francisco, CA
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

The Lab Operations Manager will assist in setting up the new Loxo Oncology at Lilly labs at the SSF or NYC site with primary responsibility for management and oversight for the Loxo Discovery Biology labs. The role will also provide support to Loxo Discovery Biology operations in meeting the emerging needs of all programs and projects including maintaining tissue culture stocks and cell line validation. 
Roles and Responsibilities of the Position
  • Coordinate with Loxo Discovery Biology team members and facilities to understand the overall scope for each lab and work directly with  relevant team members to gather, revise, finalize and ensure delivery of the lab requirements (and associated documents) to the lab construction lead coordinators.
  • Actively engage in preparing lab equipment list and coordinate with internal and external resources to finalize and manage all changes to the list.
  • Actively engage in identifying equipment vendors and liaise in enabling purchase and delivery of the equipment to the SSF or NYC site.
  • Coordinate with SSF or NYC internal Facilities to actively monitor the overall progress of the lab build up to ensure alignment with the agreed upon lab build up plan.
  • Actively engage in operationalizing SSF or NYC Loxo Discovery Biology labs.
  • Facilitate in understanding lab ordering needs and coordinate with Loxo operations to create/extend existing procurement set up.
  • Lead in ordering and stocking up all lab reagents and materials once the labs are commissioned and maintain inventory to meet the labs’ daily operational needs.
  • Lead in setting up lab management processes, create necessary documentation, and manager user training to the lab personnel.
  • Contribute to cell line expansion, authentication, and banking.
  • Facilitate in managing day-to-day lab operational activities by coordinating with different team members to ensure the stated set up is appropriate.
  • Apply creative problem solving and resourcefulness to navigate through unknown events, able to find solution with moderate supervision.
  • Adaptive to change in priorities and able to navigate through identifying and managing the changes effectively.
  • Able to effectively communicate and navigate through technical and non-technical audiences across cross-functional departments within the company, vendors, and external collaborators.
  • Contribute to building positive, collaborative teams across various scientific disciplines and encouraging sharing of new ideas, and creative ways to problem solving. 
Required Qualifications and Preferred Background
  • 5+ years of Biotech and Pharmaceutical industry experience in working in the scientific field with up to 2 years of lab management experience, and a bachelor’s degree or advanced degree in relevant scientific fields (e.g., biology) required. Experience in working with diverse set of scientific environments and able to execute requests with moderate supervision
  • Clearly understand the distinction between high-level scope and day-today operations
  • Comfortable in collaborating with the vendors
  • Good verbal, written communication, and interpersonal skills
  • Excellent organizational skills, efficient, with strong attention to detail
  • Ability to anticipate problems and proactively propose solutions
  • Experience with standard tissue culture protocols.
  • Proficient in MS Office suite 
Available locations for this role
  • South San Francisco, CA
  • New York City, NY
Physical Demands/ Travel:
 
The physical demands of this job are consistent with a laboratory bench setting.
 
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
 
 
Work Environment:
 
This position’s work environment is in a lab.  
 
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Lab Operations Manager, Large Molecule Discovery R&D
Function:
Discovery Biologics
Location:
South San Francisco, CA
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

The Lab Operations Manager will assist in setting up the new Loxo@Lilly Biologics labs at the SSF site with primary responsibility  for management and oversight for the Loxo Biologics labs. The role will also provide support to Loxo Biologics Operations in meeting the emerging needs of all programs and projects. 
Roles and Responsibilities of the Position
  • Coordinate with Loxo Discovery team members and Facilities to understand the overall scope for each lab and work directly with  relevant team members to gather, revise, finalize and ensure delivery of the lab requirements (and associated documents) to the lab construction lead coordinators.
  • Actively engage in preparing lab equipment list and coordinate with internal and external resources to finalize and manage all changes to the list.
  • Actively engage in identifying equipment vendors and liaise in enabling purchase and delivery of the equipment to the SSF site.
  • Coordinate with SSF internal Facilities  to actively monitor the overall progress of the lab build up to ensure alignment with the agreed upon lab build up plan.
  • Actively engage in operationalizing SSF Loxo Biotherapeutics labs.
  • Facilitate in understanding lab ordering needs and coordinate with Loxo operations to create/extend existing procurement set up.
  • Lead in ordering and stocking up all lab reagents and materials once the labs are commissioned and maintain inventory to meet the labs’ daily operational needs.
  • Lead in setting up lab management processes, create necessary documentation, and manager user training to the lab personnel.
  • Facilitate in managing day-to-day lab operational activities by coordinating with different team members to ensure the stated set up is appropriate.
  • Apply creative problem solving and resourcefulness to navigate through unknown events, able to find solution with moderate supervision.
  • Adaptive to change in priorities and able to navigate through identifying and managing the changes effectively.
  • Able to effectively communicate and navigate through technical and non-technical audiences across cross-functional departments within the company, vendors, and external collaborators.
  • Contribute to building positive, collaborative teams across various scientific disciplines and encouraging sharing of new ideas, and creative ways to problem solving. 
Required Qualifications and Preferred Background
  • 5+ years of Biotech and Pharmaceutical industry experience in working in the scientific field with up to 2 years of lab management experience, and a bachelor’s degree or advanced degree in relevant scientific fields (e.g., Biology) required. Experience in working with diverse set of scientific environments and able to execute requests with moderate supervision
  • Clearly understand the distinction between high-level scope and day-today operations
  • Comfortable in collaborating with the vendors
  • Good verbal, written communication, and interpersonal skills
  • Excellent organizational skills, efficient, with strong attention to detail
  • Ability to anticipate problems and proactively propose solutions
  • Proficient in MS Office suite 
Physical Demands/ Travel:
 
The physical demands of this job are consistent with a laboratory bench setting.
 
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment:
 
This position’s work environment is in a lab.  
 
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Lead Clinical Data Manager (Multiple Locations)
Function:
Clinical Data Management
Location:
Remote
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

The Lead Clinical Data Manager is responsible for leading and overseeing data management tasks from study start-up through database lock for clinical trials.  This individual works collaboratively across multiple cross functional groups including Clinical Trial Managers (CTM’s), Biostatistics and Clinical Data Management vendors to ensure database development, data review/cleaning, database auditing, database lock, and receipt of final database deliverables are in compliance with standard operating procedures and regulatory agency guidelines. The Lead Clinical Data Manager ensures all Clinical Operations activities stay within full compliance of Loxo standard operating procedures (SOP) and regulatory agency guidelines.
Roles and Responsibilities of the Position
  • Represents Clinical Data Management at study team meetings with responsibility for operational execution of CDM activities.
  • Executes and manages data management timelines to coordinate and synchronize deliverables with the overall study timelines.
  • Generates and/or reviews/approves study documents (e.g. Data Management Plans, Case Report Forms, data transfer specifications, SAE and/or external data reconciliation plans, coding conventions, study protocols, UAT execution).
  • Executes and/or distributes data management metrics, listings, and reports, as required.
  • Escalate resource need to PL to meet the current study needs.
  • Effectively apply knowledge of applicable internal, external and regulatory requirements/expectations (MHRA, FDA, ICH, GCP, PhRMA, Privacy, etc) to data collection and DM plans.
  • Collaborate and oversee CRO/service providers on assigned studies.
  • Executes/manages all data management activities on assigned studies to ensure project timelines are met.
  • Continually seek means of improving processes to reduce cycle time and decrease work effort.
  • Provides training on the CRF completion guidelines and EDC system at Investigator meetings and to internal or external team members, as needed.
  • Proactively identifies potential study issues/risks and recommends/ implements solutions.
  • Responsible for the accuracy and completeness of the clinical data collected during a clinical trial for all data deliverables.
  • Provide DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables.
  • Work with partners to increase vendor/partner efficiencies.
  • Performs any and all other tasks and activities as requested.
Required Qualifications and Background
  • Bachelor’s degree in life sciences, math, computer science or related field required.
  • Minimum of 6+ years’ clinical data management experience. 
  • Demonstrated leadership and project management skills.
  • Thorough and broad knowledge of data management processes, including EDC and interactive voice response system (IVRS)experience.
  • Demonstrated proficiency in MS Office (Outlook, MS Word, Excel, PowerPoint).
  • Experience with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug.
  • Good working knowledge of regulatory guidelines such as GCP, 21 CFR Part 11 etc.
  • Knowledge of industry standards (CDISC, SDTM, ADaM, CDASH).
  • Excellent verbal, written and interpersonal skills required for working successfully in a cross-functional team environment.
  • Able to communicate and collaborate effectively with cross-functional teams in face-to-face conversation, by telephone and by email.
  • Proven ability to work independently as well as in a team environment.
  • Excellent time management skills and a proven ability to work on multiple projects at any given time in a fast-paced environment.
  • Demonstrated ability to stay abreast of trends and new information in the profession.
  • Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment.
  • Able to communicate and collaborate effectively with cross-functional teams in face-to-face conversation, by telephone, and by email.
Additional Preferred Qualifications
  • 5+ years prior oncology/hematology experience highly desirable.
  • 2+ years prior sponsor experience preferred.
  • Recent Phase 3 registration study and submission experience preferred.
Available locations for this role
  • Stamford, CT
  • South San Francisco, CA
  • US Based-Remote
Physical Demands / Travel

The physical demands of this job are consistent with light office duties. This position will travel occasionally; the average travel for this position is 15-20% with some variation based upon the demands of the business imperatives.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in a home-based office setting.  

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Manager Project Management, Large Molecule Discovery Biologics (Multiple Locations)
Function:
Discovery Biologics
Location:
South San Francisco, CA
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

The Manager, Project Management will play a prominent role in implementing strategic goals through project execution as a part of Loxo Oncology Large Molecule Discovery Biologics portfolio. Loxo Biologics focuses on research, preclinical, and early development within Loxo Oncology at Lilly.

The role will be responsible for understanding strategic goals and facilitating the planning and execution of deliverables within scope, budget, and timeline in a cross-functional, dynamic environment. The role will work closely with team members across Loxo Oncology Large Molecule group to assess needs for outsourcing as well as actively engaging in identifying, establishing and managing external collaborators and vendors to meet any outsourcing needs.
Roles and Responsibilities of the Position
  • Facilitate in translation of strategic program goals into project plan(s) clearly outlining deliverables, milestones, no-go decisions.
  • Engage with functional team leads of antibody discovery, translational, mechanistic biology, and protein engineering (and other key stakeholders) to plan, execute, and track project activities ensuring alignment of project deliverables with strategic goals.
  • Create and manage project meetings with internal and external stakeholders (create agendas, minutes, and track action items).
  • Proficient in adaptive communications; effectively manage communications vertically and horizontally in a cross-functional environment involving external and internal stakeholders.
  • Proactively contribute and manage project communications. Identify gaps and ambiguities in communication channels and address them to maintain alignment across the team.
  • Actively contribute to create project updates, reports, presentations, and memos and maintain project document repository.
  • Identify and assess the needs for outsourcing, establish relationships with external collaborators, and manage alliances on an ongoing basis.
  • Manage day-to-day operational activities by coordinating with stakeholders from different functional departments - legal/Business operations, procurement, finance, and other relevant functional areas.
  • Adaptive to change in priorities and able to drive project outcomes ensuring re-alignment with program deliverables in changing landscape.
  • Contribute to implementing visions of building and operationalizing large molecule discovery labs.
  • Contribute to building positive, collaborative teams across various scientific disciplines, and encouraging sharing of new ideas, and creative ways to solve problems often needed in discovery research.
  • Support the creation of an organizational project framework for different functional groups and build operational guidelines and processes.
Required Qualifications and Background
  • Bachelor’s Degree in relevant scientific discipline (i.e.; biology, biochemistry, etc.) and a minimum 5-6 years of project management experience in project management roles in Biotech and pharmaceutical research and early phase large molecule discovery set up. 
  • Excellent verbal, written communication and interpersonal skills.
  • Excellent organizational skills, efficient, with strong attention to detail.
Additional Preferred Qualifications
  • Advanced degree in relevant scientific fields (e.g., Biology) strongly preferred.
  • PMP certification  desirable, but not required.
  • Experience managing projects in early stage, large molecule discovery in large molecule discovery operations.
  • Understand distinctions between high-level program goals and day-today operations.
  • Experience in managing external suppliers, vendors, and other external alliances.
  • Ability to anticipate key challenges and proactively propose solutions.
  • Adaptive to changes and apply creative problem-solving skill to meet project and other operational needs.
  • Proficient in identifying and applying tools to effectively manage and track projects - MS Office suite, MS Project.
  • Create and implement new tools and work towards creating and implementing processes customized for furthering discovery research.
Available locations for this role
  • South San Francisco, CA
  • US Based-Remote
Physical Demands / Travel

The physical demands of this job are consistent with light office duties.  Travel (post-COVID) TBD.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office or remote based.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Manager, CMC Analytical Chemistry
Function:
CMC
Location:
Boulder, CO
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

The Loxo Oncology at Lilly Chemical Manufacturing Controls (CMC) team has an immediate opening for an experienced analytical chemist in the CMC group. The individual will be responsible for analytical testing associated with non-clinical through cGMP manufacturing operations, including laboratory development work and analytical testing at external contract research, development, and manufacturing organizations (CDMOs).  The current position is remotely based, however, will require a physical presence in Boulder, CO upon completion of laboratory buildout.

Loxo Oncology at Lilly is looking for an independent self-starter to assist with method development, method transfers, and method qualifications/validations of IND stage molecules into phase I/II clinical trials. This individual will be responsible for troubleshooting drug substance and drug product analytical issues that arise during development, the preparation of technical reports, and authoring/reviewing drug product and drug substance sections of CMC regulatory submissions.
Roles and Responsibilities of the Position
  • Work collaboratively with process chemistry, pharmaceutics, QA, medicinal chemistry, CMC regulatory, and clinical development to support the delivery and release of test articles for different phases of animal and human studies.
  • Manage the development, transfer and qualification/validation of analytical methods to support starting material, intermediate, drug substance and drug product testing at CMOs/CTOs.
  • Author and review technical documents, analytical development reports, and CMC sections for IND, IMPD and global marketing applications.
  • Manage multiple projects, set priorities, and work in a fast-paced environment.
  • Collaborate with CMC and regulatory colleagues to establish and justify specifications for drug substances, starting materials, intermediates and drug products.
  • Review and approval of analytical results, protocols and reports.
  • Monitor and evaluate results of drug product and drug substance stability studies.
  • Collaborate with QA, CMC team and CMOs towards timely generation and approval of documents.
  • Other duties as assigned.
Required Qualifications and Background
  • BS/MS/Ph.D. in analytical chemistry or related discipline with a minimum of 5 years experience in the pharmaceutical industry.
  • Requires a strong background in analytical method development, applying analytical techniques to solve challenging problems, and experience in IND-enabling and clinical stability study design/management.
  • Demonstrated proficiency in both hands-on analytical work, as well as managing activities, reviewing and organizing analytical data and solving analytical challenges at third party pharmaceutical manufacturers.
  • Experience authoring and reviewing technical documents including, but not limited to, development reports, analytical testing methods, specifications, and evaluation of stability data.
  • Experience in drafting or reviewing CMC sections of INDs and IMPDs.
  • Experience in responding to inquiries from regulatory agency review.
  • In-depth knowledge of USP, regulatory, ICH and cGMP requirements.
  • Experience in late stage drug development.
  • Demonstrated ability to work well with other accomplished professionals within and across functions/teams.
  • Strong written and oral communication skills.
  • Ability to multi-task and shift priorities rapidly to meet tight deadlines.
  • Self-motivated, and keen to improve processes and overcome inefficiencies.
Physical Demands / Travel

The physical demands of this job are consistent with light office duties. This position requires occasional travel.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office with some traveling in the field.  

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Manager, Facilities (Multiple Locations)
Function:
Facilities/EHS
Location:
South San Francisco, CA
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

The Facilities Manager will oversee and coordinate all site-related activities for Loxo Oncology at Lilly personnel in their designated site. The Manager, Facilities will identify and manage external vendors to ensure safe and efficient laboratory and office spaces for Loxo scientists on site. Working cross functionally, the Facilities Manager will excel at relationship building at all levels of the organization and thrive in a fast-paced environment. The Manager, Facilities will work closely with the Loxo Facilities and IT department teams to set strategy, develop long-term planning, oversee construction and successfully execute projects. The goal is to ensure Loxo’s business accommodation is problem-free and safe so that employees can work under the best conditions.
Roles and Responsibilities of the Position
  • Identify and manage external vendors across multiple functions within the facility operation to ensure alignment with Loxo Oncology department heads and scientists.
  • Responsible for oversight of the installation and qualification of laboratory equipment.
  • Work with the Loxo Facilities and IT department teams on strategy, long-term planning, new construction, and project execution.
  • Manage and review service contracts.
  • Oversee the design, construction and occupancy of laboratory and office spaces for the Loxo employees on site.
  • Check completed work by vendors and contractors.
  • Contribute to the creation of Site Operational Budget and annual Site Capital Budget for Loxo.  Ensure site budgets are managed and maintained.  Provide budget forecasts for site as required.
  • Frequent contact and interaction with department heads, outside agencies/architects, and government and municipal representatives.
  • Allocate office space according to needs of Loxo personnel.
  • Keep financial and non-financial records.
  • Forecast, allocate, and supervise the financial and physical resources of the facility management.
  • Recommend maintenance, mechanical, electrical, and facility design modifications.
  • Prepare cost estimates for moves and equipment.
  • Ensure that the facility is clean and maintained according to company policy and procedures.
  • Negotiate bids and contracts for third-party services.
  • Manage and coordinate work with 3rd-party vendors including tracking work order completion, vendor and client follow up, validating/approving subcontractor invoices.
  • Oversee the implementation of Environmental, Health and Safety programs for Loxo personnel on site.
  • Conduct and document regular facilities & EHS inspections.
  • Manage the upkeep of equipment and supplies to meet the required health and safety standards.
  • Responsible for preparing for, responding to and taking corrective action for any EHS or other site audits.
  • Maintaining a safe work environment for all employees.
  • Serve as emergency response coordinator for Loxo and attend site emergency preparedness meetings.
  • Maintain regular communication with building, landlord or Lilly Facilities staff, staying current on building requirements that could impact Loxo.
  • Other duties as required.
Required Qualifications and Background
  • 5+ years of experience in a Facilities role with a strong preference for pharma/biotech experience specifically in a laboratory setting.
  • Excellent verbal and written communication skills.
  • Excellent organizational and leadership skills.
  • Good analytical/critical thinking.
  • Knowledge of basic accounting and finance principles.
  • Adept at building and managing relationships with local vendors, government and municipalities.
  • Assists team members when needed to accomplish company goals.
  • Able to multitask, prioritize, and manage time efficiently.
  • Goal-oriented, organized team player.
  • Encouraging to team and support personnel; able to mentor and lead.
  • Self-motivated and self-directed.
  • Experienced at compiling and following budgets.
  • Accurate and precise attention to detail.
  • A positive attitude and excellent problem-solving skills.
  • Computer skills; including Microsoft Office Suite.
  • Strict adherence to company philosophy/goals.
Available locations for this role
  • South San Francisco, CA
  • San Diego, CA
  • New York, NY
Physical Demands / Travel

The physical demands of this job are consistent with office duties/working in a lab space. Ability to physically stand, bend, squat, and lift, up to 25 pounds.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office/lab.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Manager, Small Molecule Biology Operations
Function:
Discovery Small Molecule
Location:
Remote
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

Loxo Oncology at Lilly has an immediate opening for a Small Molecule Biology Operations Manager. The Loxo Oncology at Lilly Drug Discovery team’s mission is to invent life-changing targeted therapies for cancer patient populations that are poorly treated by existing therapies. To that end, we have built a multi-disciplinary team of dedicated drug discovery scientists who are passionate about driving the science forward to create highly selective drugs for known oncogenic drivers. We are currently looking for a Small Molecule Biology Operations Manager to assist with the coordination and execution of biology initiatives and projects. This position will provide direct support to our Vice President, Small Molecule Biology. This position will have direct accountability for administrative deliverables while interacting regularly with cross-functional teams and scientists. The manager will be required to build a thorough understanding of all teams within Small Molecule Biology and the broader discovery organization and apply that knowledge to effectively support strategic and tactical initiatives consistent with the organizational strategy. 
Roles and Responsibilities
  • Coordinate implementation and tracking of activities across small molecule biology teams, at the direction of the VP, Small Molecule Biology
  • Facilitate successful program and task execution
  • Working with project stakeholders and technical leaders to enable open lines of communication
  • Track, prioritize and manage critical issues
  • Help to consolidate suggestions and share back with VP, Small Molecule Biology
  • Keep pulse on a high level overview of work taking place in small molecule biology, recommend efficiencies as needed
  • Provide strategic oversight of Loxo Oncology at Lilly’s in vivo network, manage CROs and help coordinate the use of our various locations to meet the needs of new work
  • Work with scientific team to establish guidelines and streamline a variety of processes such as: attendance at scientific meetings, internal training
  • The successful candidate will have a high-level understanding of science, but will primarily be focused on strategic, logistics, and administrative management
  • Summarize and present information in PowerPoint
  • Collate information from technical documents
Required Qualifications
  • Bachelor’s in biological field
  • 5+ years of experience in R&D within the pharmaceutical, biotech or related industry
Preferred Background
  • The ideal candidate will be: highly organized, a strong communicator, flexible, accountable and able to take initiative and see tasks through to completion
Physical Demands/Travel:
The physical demands of this job are consistent with light office duties.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment:
This position’s work environment is in an office or remote based.   

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.


*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Manager/Senior Manager, Clinical Supply Management
Function:
Clinical Supply
Location:
Remote
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

Position Summary:
The Manager/Senior Manager, Clinical Supply Management will support Clinical Supply Management by conducting various work streams with internal and external team members for the on-time delivery of clinical supplies across the Loxo Oncology at Lilly portfolio.
Roles and Responsibilities of the Position:
  • Support Clinical Supply Management by contributing to various work streams with internal and external team members for the on-time delivery of clinical supplies across the oncology portfolio.
  • Update and maintain study supply plans including drug supply forecasts for manufacturing, packaging, and labeling operations.
  • Provide oversight of packaging and distribution collaboration partners including, but not limited to document review of packaging specifications, master, and executed batch records, distribution instructions and order processing and delivery.
  • Provide on-going monitoring of inventory and expiration dates for assigned program/study. Ensures alignment with supply forecast and study/program requirements.
  • Manage global accountability tracking including destruction for assigned programs.
  • Support clinical label development process including creation of master label text, translations, and label proofs.
  • Review and provide input to documents including, but not limited to: pharmacy manuals, IMPDs, request for proposals, and IRT/IWRS specifications.
  • Participate on project teams and sub-teams as needed and assigned
  • Track progress versus timelines and goals.
  • Ensure documents and records are kept in compliance with regulations and SOPs including the Trial Master File (TMF).
Required Qualifications and Preferred Background:
  • BA/BS and 8+ years of experience working in a Biotech or Pharmaceutical FDA regulated industry in Clinical Supply Management or a related field or an equivalent combination of education, training and/or experience from which comparable knowledge, skills and abilities have been attained.
  • Solid understanding of pharmaceutical development, manufacturing, packaging, and labeling.
  • Eager to communicate and collaborate with team members across functions including but not limited to: clinical operations, CMC, regulatory affairs, and QA.
  • Working knowledge of cGMP’s (CFR/ICH) and GCP and applicable international regulations/guidelines.
  • Prefer experience working with third-party vendors and contractors, knowledge of QP requirements, and import/export.
  • Global experience with phase 1-4 clinical trials.
  • Experience writing and presenting clearly on clinical supply topics.
  • Ability to work in a virtual environment.
Physical Demands:
The physical demands of this position are consistent with light office duties.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
 
Work Environment:
This position’s work environment is based in a typical office setting.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
 

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Manager/Sr. Manager, Pipeline Medical Affairs
Function:
Diagnostic Medical Affairs
Location:
Stamford, CT
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

Position Summary:
In this role, you will lead the strategic planning, development and approval of pipeline asset material generation and management. This can include medical decks, trial recruitment materials, congress materials, trial logo branding, lexicon, etc. You will be responsible for external thought leaders (TL) engagement (i.e. planning and execution of advisory boards, congress planning support), and scientific platform development. Additionally, you will be expected to provide strategic input for data disclosure plans.

Roles and Responsibilities of the Position:
  • Manage vendors for creation of asset materials and for external thought leader (TL)engagement activities
  • Provide medical review in MRC
  • Bring relevant and current external clinical insights to early phase team relevant to their molecule/program plans, etc.
  • Attend relevant conferences and highlight important sessions
  • Interface with various functional groups in the Oncology Business Unit (OBU) (centralized congress team, medical information, MSLs, etc.)
  • Work with the TL advisor group/other relevant teams to ensure integration of external engagement plans for early phase assets into the broader overall US/Global/OBU KOL engagement plans
  • Provide and review quarterly pipeline updates to the external engagement team in the OBU
  • Liaise between the early phase clinical development teams and the OBU
  • Transfer asset knowledge to OBU teams for early launch planning
Required Qualifications and Preferred Background:
  • Minimum of a Bachelor's degree in a science-related health field advanced degree, PharmD/PhD/MD strongly preferred
  • 1-3 years related experience in the pharmaceutical or biotech industry required
  • Oncology and/or Medical Affairs experience heavily preferred
  • Excellent communication and interpersonal skills
  • Attention to detail and organizational skills are required
  • Good learning agility and flexibility to adjust quickly and effectively to changing business priorities and needs
Physical Demands/ Travel:
 
The physical demands of this job are consistent with office duties. Up to 25% travel may be required.
 
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
 
 
Work Environment:
 
This position’s work environment is in an office based environment.   
 
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
 

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Medical Monitor (Multiple Locations)
Function:
Medical
Location:
South San Francisco, CA
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

The Medical Monitor will lead and support the expansion of clinical development programs (or one large, complex program) in support of the overall product development plan and serve as an ambassador and resource to various physicians and clinical trial sites, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, Loxo customers, markets, business operations, and emerging issues, and perform other responsibilities as requested.
Roles and Responsibilities of the Position
  • Primary responsibility for and ownership of design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents.   
  • May participate in or lead clinical development contributions to due diligence or other business development activity.  As required by program needs, contributes in partnership with research colleagues to design and implement translational strategies.
  • Acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
  • Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. May represent Loxo at key external meetings.
  • Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions.
  • Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research. 
Required Qualifications and Background
  • MD, Board certification in Oncology or equivalent.
  • PhD would be an advantage.
  • 1+ years Clinical Trials/Research experience in pharmaceutical industry, academia, or equivalent.
  • Ability to exercise judgment and address complex problems and create solutions for one or more projects.
  • Ability to develop collaborative working relationships with physicians, expert consultants, and contracted vendors.
  • Strong analytical mind and problem-solving skills, attention to detail, strong organizational skills, and ability to work independently and as part of a team.
  • Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be able to lead through influence.
  • Proven ability to interact externally and internally to support a global scientific and business strategy.
  • Strong document management skills, including proficiency with MS Word, EndNote, PowerPoint and Excel.
  • Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
  • Strong communication skills both written and oral.
  • Ability to multi-task and shift priorities rapidly to meet tight deadlines.
Available locations for this role
  • South San Francisco, CA
  • Stamford, CT
Physical Demands/ Travel:
 
The physical demands of this job are consistent with light office duties. This role will require 50-60% travel.
 
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
 
Work Environment:
 
This position’s work environment is in an office / traveling in the field to both US and International locations.  
 
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Pharmacology Principal Scientist
Function:
Pharmacology
Location:
Indianapolis, IN
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

The Pharmacology Principal Scientist will be responsible for identifying, developing, and performing robust, reproducible in vitro and in vivo assays to support tier 1-3 assays.  The Scientist will provide hands-on compound testing to support the small molecule drug discovery oncology pipeline and will be responsible for characterizing the effects of small molecule compounds on specific protein targets using multiple assay formats. A strong background in experimental curve-fitting, statistics, and assay optimization and execution is required.
Roles and Responsibilities of the Position
  • Develop robust Tier 1 - 3 assays including biochemical (enzyme and binding), cell based (e.g. target inhibition, proliferation etc), tumor models (development and analysis).
  • Design, execute, and trouble-shoot experiments.
  • Perform comprehensive data analysis.
  • Communicate experimental findings to team members.
  • Actively engage in advancing drug discovery.
  • This is a “hands-on” laboratory based position.
Required Qualifications and Background
  • BS/MS/PhD in oncology, biology, biochemistry or related fields with 8+ years of related experience.
  • Ability to leverage multiple assay platforms to measure target engagement, pathway modulation and cell sensitivity in response to compounds.
  • Strong understanding of oncology and signaling pathways.
  • Continual learner and possesses a can-do attitude.
  • Excellent oral and written communication skills including experimental documentation.
  • Ability to multi-task and shift priorities rapidly to meet tight deadlines.
  • Possess personal accountability for excellent and timely results.
  • Highly organized with exceptional attention to detail.
  • Demonstrate ability and willingness to work effectively in a highly collaborative research environment.
  • Proficient in Microsoft Office suite and applications.
  • Experience with biochemical and kinetic-based assay technologies (e.g. FP, TR-FRET, AlphaScreen, Luminescence).
  • Experience with laboratory instrumentation and automation.
  • Cell culture expertise (cell lines and primary cells) including clonal cell isolation techniques. Solid and liquid tumor cell lines.
  • Hands-on experience in lentivirus production, titration, and transduction.
  • Demonstrated experience in developing cell-based assay to monitor protein levels and modifications including the following methods:   ELISA, In-Cell Westerns, Mesoscale, HTRF, AlphaScreen, MALDI-TOF MS.
  • Cell viability, proliferation and apoptosis assays.
  • Experience with multiplexed antibody-based detection methods (e.g. Luminex, Mesoscale).
  • Tumor and/or tissue sample handling and processing for biomarker analysis.
  • Ability to perform quantitative data analysis, curve fitting, statistics etc.
  • Experience developing multi-channel flow cytometry based screening assays including sample preparation, staining, operating flow cytometers, and analyzing flow.
  • Tumor biology including cell line xenograft and/or PDX models in oncology setting.
Additional Preferred Qualifications
  • Metabolite analysis in cells and tumors.
  • Experience with small molecule compound testing.
  • Proficient in CRISPR, shRNA and/or siRNA gene regulation.
  • Organoid or 3D culture method development.
  • Colony formation assay experience.
  • High content cellular imaging skills.
  • Expertise in running high-throughput and automated cancer cell proliferation panels.
  • Experience in confocal microscopy.
  • Gene expression profiling of tumor samples.
  • Experience in the generation and analysis of mouse cancer models.
  • Experience with tumor implantation techniques and dosing, tumor measurement, health monitoring, and data collection and analysis.
  • In vitro and ex vivo experience analyzing biomarkers (examples include flow cytometry, IHC, ELISA, RT-PCR, Westerns, Luminex).
  • Experience with bioluminescent imaging studies.
  • Understanding of PK, PD, and PK/PD relationship.
Physical Demands / Travel

The physical demands of this job are consistent with a laboratory setting.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office and a lab. 

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Principal Scientist, Genome Engineering Team Lead, Discovery Technologies
Function:
Discovery Biologics
Location:
New York, NY
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

The Principal Scientist, Genome Engineering Team Lead in the Discovery Technologies group, will lead a large and dynamic group of scientists conducting various research projects to identify large molecule/biologics which can effectively treat various forms of cancer. This individual will design, perform and oversee experiments involving extensive use of molecular biology techniques designed to engineer various biological systems including cell lines, organoids and primary cells.  The Team Lead will be responsible for working both with internal capabilities and managing external collaborations.  They will report their findings to both the Loxo scientific and executive leadership, and will be a key member of the Loxo at Lilly organization, where you will be responsible for maintaining the scientific quality and efficiency of your organization, as well as assist and guide the strategic direction of the company.
Roles and Responsibilities of the Position
  • Scientific roles and responsibilities:
  • Oversee and/or perform assays designed to modulate targets of interest in various biological systems including cell lines and organoid systems (i.e. CRISPR, siRNA)
  • Liaise with CROs and vendors to outsource activities, provide input to management team on vendor selection
  • Identify, construct and source (as needed) appropriate models for drug testing as needed by project teams in large and small molecule teams
  • Provide scientific expertise when determining organizations to strategically partner with
  • Interrogate experimental conduct of third parties/vendors
  • Additional responsibilities:
  • Lead, coach, develop, and manage teams
  • Liaise with internal teams (within Loxo, or Lilly) and provide guidance on key strategic decisions of the business
  • Indirectly oversee work of third parties/vendors (e.g., CROs)
  • Manage resource allocation effectively
  • Build roadmaps to execute on specific targets, and overall strategic projects
Required Qualifications and Background
  • PhD in cellular biology, immunology, or allied disciplines with minimum 3 years experience
  • Expertise in organoid models and 3D co-cultures
  • Experience in isolating primary cells, establishing viable co-cultures
  • Familiarity with CRISPR, siRNA, ADC, CD3, biologic assays
  • Proven success leading, managing, and coaching large cross functional teams in dynamic organizations
  • Experience writing reports including preclinical data summaries and INDs
  • Demonstrated experience in working collaboratively across various scientific disciplines to meet end goals of business
  • Demonstrated business acumen
  • Demonstrated excellence in making key strategic decisions in support of broader business goals
  • Excellent written and verbal communication skills
Physical Demands / Travel

TBD ~10% or less. The physical demands of this job are consistent with working in a lab.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in a lab.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Principal Scientist, Histology Lead, Discovery Technologies
Function:
Discovery Biologics
Location:
New York, NY
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

The Histology Group Lead in Discovery Technologies will lead a dynamic team of scientists focused on applying cutting edge imaging technologies to support projects across Loxo discovery and clinical assets. The team will execute experiments needed to support the various research programs for identified targets. The team lead will utilize expertise in histology, imaging, and pathology to establish critical capabilities and applications. The group will be responsible for optimization and validation of target antibodies for various project immune-imaging applications and implementation of sample and assay quality control. The Histology Group Team Lead will also be responsible for maintaining the IHC equipment and facilities.  They will also be encouraged to develop their own ideas and contribute these to the broader group. This role is expected to be a dynamic and motivated lead scientist who can drive team research activities, while collaborating extensively with other cross-functional teams to execute on various research programs.
Roles and Responsibilities of the Position
  • Scientific roles and responsibilities:
  • Lead a team of experienced histology scientists to provide high quality data, imaging, analysis, and interpretation in support of projects across the oncology portfolio
  • Develop critical histology assays for targets specified by project teams
  • Expertly analyze and quantitate imaging data
  • Supervise the design and execution of studies within the group and in collaboration with multi-functional teams across Loxo discovery
  • Manage IHC laboratory assay and equipment protocols, including all required instrument maintenance to ensure proper calibration and function
  • Work collaboratively with the clinical biomarker team to perform to support retrospective and exploratory efforts for clinical programs
  • Responsible for upgrading the histology facility as technology grows in order to continue to provide cutting-edge resources to Loxo Oncology at Lilly scientists
  • Provide scientific expertise on histology to the entire R&D organization
  • Interrogate experimental conduct of third parties/vendors and outsource experiments as needed
  • Additional responsibilities:
  • Communicate results at project team meetings, be involved in the coordination and preparation of presentations
  • Discuss results with technical as well as non-technical personnel
  • Work in cross functional environments via extensive collaboration with other parts of the organization
  • Responsible for leading a team of scientists in the IHC core facility
Required Qualifications and Background
  • PhD in biological sciences with 3-5+ years of histology experience in pharmaceutical or biotech environment.
  • Extensive experience with IHC, multiplex, and high-resolution histology platforms
  • Prior experience running a histology core facility is essential
  • Deep expertise in cancer disease states (indications, mutational status, tumor cell drivers)
  • Extensive expertise in antibody validation for IHC
  • Experience with multi-color IHC
  • Expertise in quantification of stained slides
  • Demonstrated experience in working collaboratively across various scientific disciplines to meet end goals of business
  • Excellent communication and interpersonal skills
  • Demonstrated ability to succeed in a fast-paced environment, working on multiple projects with constantly changing priorities and deadlines
  • Excellent written and verbal communication skills
Physical Demands / Travel

TBD <5%. The physical demands of this job are consistent with working in a lab.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in a lab. 

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Principal Scientist, In-Vivo Pharmacology Team Leader
Function:
Discovery Biologics
Location:
New York, NY
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

Position Summary:
The In Vivo Pharmacology Team Lead, Discovery Technologies will lead a dynamic group of scientists conducting various research projects to test large molecule/biologics or small molecules which can effectively treat various forms of cancer. This individual will collaborate with teams in NYC, South San Francisco, Indianapolis and Boulder for design and execution of studies as needed. The Team Lead will design and oversee experiments involving humanized mouse models, in vivo pharmacology, and will also be responsible for overseeing, collaborating, or performing in vivo PK/PD studies done in preclinical models including ex vivo assays. Members of the In Vivo Pharmacology Team will collaborate closely with multi-disciplinary teams, providing expertise throughout all stages of the lifecycle of new target development to advance our portfolio. Oversight and/or contribution to ADME work during drug development may be required. The In Vivo Pharmacology Team Lead will report findings directly to both the Loxo Oncology at Lilly scientific and executive leadership, and will be a key member of the large molecule organization being responsible for maintaining the scientific quality and efficiency of the organization, as well as assist and guide the strategic direction of target priorities for the preclinical portfolio.
 
Roles and Responsibilities of the Position:
  • Design and execute in vivo studies using humanized mouse models, xenografts and syngeneic mouse model systems
  • Lead and work collaboratively across multiple laboratory-based functions to establish the mechanisms, phenotypes, and biology of new targets
  • Provide strategic input, in partnership with Discovery leadership, into all facets of in vivo target identification and validation studies
  • Develop model systems and platforms for mechanism-based studies of targets and new target discovery internally, or acquire through partnerships in collaboration with Discovery leadership and business development
  • Develop key capabilities for the generation of necessary cellular models for detailed functional characterization
  • Communicate results at project team meetings and strong involvement in the coordination and preparation of team presentations; responsible for study report drafting for internal record keeping as well as regulatory filings
  • Discuss results with technical as well as non-technical personnel
  • Work in cross-functional environments via extensive collaboration with other areas and teams of the discovery organization
  • Interrogate experimental conduct of third parties/vendors
  • Provide strategic input on the development of key experimental resources, experimental platform-based discovery business development
Required Qualifications and Background:
  • PhD in biological discipline including but not limited to biochemistry; molecular, cellular, or cancer biology with 5-10 years of experience (pharmaceutical experience strongly preferred)
  • Extensive expertise in in vivo techniques, small animal handling, carrying out preclinical rodent oncology modeling
  • Diverse experience in cell biology and biochemical techniques to monitor PK/PD relationships is essential
  • Experience in drug discovery with regulatory reporting
  • Demonstrated ability to succeed in a fast-paced environment, working on multiple projects with constantly changing priorities and deadlines
  • Excellent communication and interpersonal skills
Physical Demands/ Travel:
 
The physical demands of this job are consistent with work in a lab.
 
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
 
 
Work Environment:
 
This position’s work environment is in a lab. 
 
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Principal/Senior Principal Scientist, Toxicology
Function:
Toxicology
Location:
Boulder, CO
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

The Toxicologist will be responsible for the planning, execution, and monitoring of DMPK and toxicology studies for advancing candidates through early target assay development, lead optimization, candidate selection and into IND-enabling studies and beyond.
Roles and Responsibilities of the Position
  • Evaluate new targets for potential toxicological liabilities.
  • Create novel experimental designs for mechanistic toxicology studies, including DMPK considerations, designed to assess hypotheses for and evaluate mechanisms of toxicity related to physiological or biochemical functions.
  • Support predictive toxicology experimental efforts within Discovery (e.g., in vitro cell-culture based, animal models of disease) analyze safety-related data and use it to make decisions.
  • Develop early safety assessment and ensure appropriate toxicology studies and liability screens are performed to support nomination of drug candidates for further development.
  • Communicate results clearly and concisely in both oral and written reports and presentations.
  • Perform in depth pathway/network analysis on data derived from toxicology and other studies and disseminate results to the wider toxicology community (internally and externally).
  • Closely interact with scientists in other functional areas.
Required Qualifications and Background
  • Ph.D. in toxicology required, along with 10+ years’ experience as a toxicologist within the biopharmaceutical industry. Board certification in Toxicology strongly preferred.
  • Previous small molecule oncology therapeutic product development experience in a pharmaceutical or biotechnology company is preferred.
  • Familiarity with GLP regulations and regulatory guidelines for the testing of biopharmaceutical products and experience with compilation of toxicology information into various regulatory submission documents is desirable. 
  • Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
  • Strong written and oral communication skills.
  • Ability to multi-task and shift priorities rapidly to meet tight deadlines.
  • Excellent written and verbal communicator.
  • Detail oriented and well organized.
  • Good and thoughtful listener.
  • Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.
  • Proficient in Microsoft Office suite and applications.
Physical Demands / Travel

The physical demands of this position are consistent with working in an office / laboratory/ environment. Some light lifting, and maneuvering may be required.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office and lab with some remote responsibilities.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Project Manager, Large Molecule Discovery R&D (Multiple Locations)
Function:
Discovery Biologics
Location:
South San Francisco, CA
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

The Project Manager will play a prominent role in managing projects within the Large Molecule Discovery R&D program portfolio with a focus on research, preclinical, and early development within Oncology. The role will be responsible for understanding project goals and facilitating the planning and execution of  deliverables within scope, budget, and timeline in a cross-functional, dynamic environment. The role will work closely with team members across Loxo Oncology Large Molecule group to assess any needs for outsourcing and actively engage in identifying, evaluating, engaging and managing external collaborators and vendors to meet outsourcing needs. 
Roles and Responsibilities of the Position
  • Coordinate with functional leads of translational, mechanistic biology, antibody, and protein engineering (and other key stakeholders) to plan, execute, track, and deliver project tasks and activities meeting project deliverables within scope, timeline, and budget.
  • Facilitate project meetings with internal and external stakeholders (if applicable) including establishing agendas, drafting minutes and tracking action items ensuring project deliverables are met.
  • Facilitate the drafting of project updates and reports, PowerPoint slide presentations, memos as needed for projects and maintain project document repository.
  • Support the creation of an organizational project management framework to be utilized across different functional groups including the build out of new process(es).
  • Actively engage in meeting project outsourcing needs by coordinating with team members to identify, assess, establish, and manage activities involving external collaborators and vendors.
  • Facilitate in managing day-to-day operational activities by coordinating with different functional teams, legal, procurement, finance, and other internal and external stakeholders.
  • Assist in building and operationalizing large molecule discovery labs.
  • Proactively navigate changes occurring in priorities and adapt to drive project outcomes ensuring re-alignment with program deliverables in changing landscape.
  • Proficient in adaptive communications. Able to effectively communicate and navigate through technical and non-technical audiences across cross-functional departments within the company and external collaborators.
  • Contribute to building positive, collaborative teams across various scientific disciplines and encouraging sharing of new ideas, and creative ways to solve problems often needed in discovery research.
Required Qualifications and Preferred Background
  • BS degree in relevant scientific fields (e.g., Biology) required; advanced degree preferred. PMP certification is desirable, not required.
  • 3-5+ years project management experience in within Biotech and pharmaceutical research within early phase large molecule discovery set up.
  • Experience in managing projects in early stage large molecule discovery in large molecule discovery operations.
  • Understand differences between high-level program goals and day-today operations.
  • Experience in managing external suppliers, vendors, and other external alliances.
  • Excellent verbal, written communication and interpersonal skills.
  • Excellent organizational skills, efficient, with strong attention to detail.
  • Ability to anticipate key challenges and proactively propose solutions.
  • Adaptive to changes and apply creative problem-solving skill to meet project and other operational needs.
  • Proficient in identifying and applying tools to effectively manage and track projects - MS Office suite, MS Project.
  • Create and implement new tools and work towards creating and implementing processes customized for furthering discovery research.
Available locations for this role
  • South San Francisco, CA
  • US Based-Remote
Physical Demands/ Travel:
 
The physical demands of this job are consistent with light office duties.
 
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
 
 
Work Environment:
 
This position’s work environment is in an office.  
 
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Record Retention Consultant
Function:
Clinical Development
Location:
Remote
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

Position Summary: The Record Retention Consultant will drive critical projects within LO@LLY, related to broader Lilly integration efforts. This role will focus in two areas: 1) Records retention across functional areas and 2) Technical processes related to integration processes (eg Box folder management, team member access and permissions, etc)
Roles and Responsibilities of the Position:
  • Serve as the internal expert on Enterprise Records Retention – fully familiarize self with Lilly’s Global Record Retention Schedule
  • Work within each functional area at LO@LLY to develop a plan and process for implementation of Lilly’s Record Retention Schedule, including any Legal Holds
  • Ability to work cross functionally between LO@LLY and Lilly to share best practices and implementation strategies.
  • Completes projects by coordinating resources and timetables with department leads and designees
  • Develops strategies for managing complex record repositories (e.g. hard copy and IT Systems)
  • Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; completing all necessary training
  • Establishes and maintains strong partnership with IT Systems SMEs
  • Manage integration Box repositories in both content and organizational access for integration work
  • Manage and oversee routine or periodic updates of integration practices, processes and supporting content; drive updating content as necessary with functional owner or SME
  • Proficient in self-management and organizational skills; able to manage workload, set priorities and adjust as needed
  • Strong interpersonal and teambuilding skills; able to develop effective teamwork between team members with diverse styles
  • Monitor and prioritize team risks to suggest ways to avoid/mitigate risks and initiate contingency plans as needed
  • Bring forward areas for continual process improvement
  • Liaise with cross-functional teams to identify, share, and incorporate best practices into future processes, tools and training
Required Qualifications and Background:
  • Bachelor’s degree preferably in a health-related, scientific or engineering field.
  • Minimum of 3 years of work experience in the pharmaceutical industry, IT, and/or QA.
  • Working knowledge in pharmaceutical records management, including electronic and hard copy media
  • Experience in implementing complex records management program/schedules across functional areas (legal, finance, clinical, etc.)
  • Strong organizational and communication skills
  • “Self-starter”, who works with minimal supervision
  • Solution oriented and works with a sense of urgency
  • Knowledge of or previous experience with technical/digital tools and/or application of compliance/QA SOPs across functional areas.
  • Proficiency with Microsoft Word, Excel, PowerPoint, Project and capable of maintaining appropriate project documentation.
  • Proficiency with Box structure, appropriate access levels and content management 
 
Physical Demands/ Travel:
 
The physical demands of this job are consistent with light office duties
 
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
 
 
Work Environment:
 
This position’s work environment is in an office/remote based
 
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Research Associate, Mechanistic Biology/Proteomics
Function:
Discovery Small Molecule
Location:
South San Francisco, CA
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

This position is an opportunity to learn and grow within a dynamic structural biology team dedicated to creating specific targeted therapeutics for genetically defined oncology targets. The Research Associate, Mechanistic Biology/Proteomics characterize the interactions of our highly selective inhibitors with their target proteins.
Roles and Responsibilities of the Position
  • Characterize protein ligand interactions using a variety of methods including but not limited to; Intact protein and peptide base Mass Spectrometry, Fluorescence Spectroscopy, and Surface plasmon resonance
  • Some experience in recombinant protein purification from a variety of cell sources to support biophysical/biochemical studies.
  • Collaborate with colleagues throughout the company to ensure timely delivery of assay data
  • Adapt to highly dynamic project priorities, with diligent and rapid communication of scientific results and insights to the team
  • Participate in discussions with vendors for outsourced services and studies.
  • Learn and develop technical expertise in protein biochemical and biophysical characterization
  • Develop and continually advance one’s knowledge base on genetically targeted drugs and structure-based drug design.
Required Qualifications and Background
  • BA/BS, MS, PhD in Biochemistry, Chemistry, or related field +
  • Ideal candidate will have with 2+ years hands-on protein characterization
  • Some experience in protein purification and construct design
  • Excellent interpersonal skills with ability to communicate and interact well with colleagues, vendors, contractors, scientific advisors, and staff at all levels.
  • Highly organized with excellent analytical, documentation and multi-tasking skills
  • Committed to staying current with the latest scientific breakthroughs in structure-based drug design and structural biology.
  • Expertise in other methods of enzymology or biophysical characterization and structural biology is a plus
Physical Demands / Travel:

The physical demands of this job are consistent with light office duties.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment:

This position’s work environment is in an office / lab / traveling in the field.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Scientific Programmer/Software Engineer, Scientific Systems (Multiple Locations)
Function:
Discovery Small Molecule
Location:
Boulder, CO
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

We are in need of a talented and creative Scientific Programmer to drive implementation and customization of software to support our growing drug discovery team. This position will be highly integrated with the science team to empower smooth collection, efficient distribution and empowered visualization on the scientific data that drives our programs. The Scientific Programmer/Software Engineer, Scientific Systems will provide programming support for the implementation of multiple Scientific Software Systems, interact with vendors to ensure successful system implementation, upgrade, integration, patching, and validation as well as documentation. 
Roles and Responsibilities of the Position
  • Work with Subject Matter Experts to define scientific user requirements and convert them into functional requirements.
  • Modify existing and develop new custom code using industry best practices.
  • Support troubleshooting, debugging, and testing of technical solutions.
  • Develop queries that process and report on complex data sets.
  • Develop system integrations using Restful APIs.
  • Prepare custom scientific reports.
  • Train end users on the use of the custom coded applications and integrations.
  • Contribute to the development of Standard Operating Procedures for Scientific Systems.
Required Qualifications and Preferred Background
  • BS degree required in Computer Science or Scientific/STEM related discipline.
  • 3+ years programming experience in a software development environment using object-oriented programming languages and current technologies such as Python, Javascript, and C++.
  • Experience with managing large data sets and developing workflows to automate complex data updates.
  • Experience with Web Services and REST APIs. 
  • Experience with building and deploying web services.
  • Experience with Web Servers (i.e. Apache, Nginx, IIS, etc).
  • Experience with SQL and databases such as Oracle, SQL Server, PostgreSQL, and/or MySQL.
  • Demonstrated ability to learn and apply new technologies according to the changing needs of the project and organization.
  • Excellent written and verbal communication skills / ability to document and communicate complex scientific concepts for a variety of audiences.
Available locations for this role
  • Boulder, CO
  • US Based-Remote
Physical Demands/ Travel:
 
The physical demands of this job are consistent with an office/laboratory bench setting
 
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
 
 
Work Environment:
 
This position’s work environment is in an office/lab.  
 
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Scientist, BioImaging, Discovery Technologies
Function:
Discovery Biologics
Location:
New York, NY
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

As a Scientist in the Discovery Technologies, Imaging group, you will be joining a large and dynamic group focused on executing experiments on the cutting edge of pharmaceutical sciences. You will design and conduct experiments needed to support the various research programs for identified targets. You will be expected to demonstrate expertise with high-quality imaging needed for biological sciences (e.g., confocal, live cell imaging, 3D assays) and well versed in all aspects of image analysis. You will be responsible for maintenance of the imaging facilities and to liaise with instrument manufacturers to ensure Loxo’s imaging facilities remain state-of-the-art. You will also be encouraged to develop your own ideas and contribute these to the broader group. You are expected to be a dynamic and motivated scientist who can drive their own experiments and research activities, while collaborating extensively with the rest of the organization to execute on various research programs.
Roles and Responsibilities of the Position
  • Scientific roles and responsibilities:
  • Design and execute studies using confocal microscopy and live cell imaging instruments
  • Assay development and cell line engineering to generate fluorescent fusions and novel signaling reporter assays
  • Image cell-cell interactions (i.e., CD3 redirection), cells expressing proteins of interest (i.e., cytokines, tumor associated antigens, organelles etc.), subcellular localization, trafficking, plasma membrane dynamics
  • Image analysis and algorithm development, data management
  • Maintain imaging facility instruments and become point of contact for any and all imaging needs for entire R&D organization
  • Interrogate experimental conduct of third parties/vendors
  • Facilitate experiments with in vivo pharmacology group
  • Additional responsibilities:
  • Communicate results at project team meetings, be involved in the coordination and preparation of presentations
  • Responsible for writing reports (internal and/or regulatory)
  • Discuss results with technical as well as non-technical personnel
  • Work in cross functional environments via extensive collaboration with other parts of the organization
  • Opportunity to directly manage junior scientists in the future
Required Qualifications and Background
  • BSc. in biological sciences with 5+ years of experience or MSc or PhD in biological sciences with 2-3 years of experience
  • PhD preferred
  • Extensive expertise in confocal microscopy and live cell imaging, assay development, high content imaging, signaling reporter assays, TIRF and image analysis
  • Experience with super resolution microscopy highly desirable
  • Experience in drug discovery an asset
  • Experience in automation and high throughput screening an asset
  • Deep expertise in translational biology concepts, history of working with organoids and 3D assays, as well as in vivo models (e.g., mice models) considered an asset
  • Expertise in cancer disease states (indications, mutational status, tumor cell drivers)
  • Demonstrated experience in working collaboratively across various scientific disciplines to meet end goals of business
  • Demonstrated ability to succeed in a fast-paced environment, working on multiple projects with constantly changing priorities and deadlines
  • Excellent written, verbal communication and interpersonal skills
Physical Demands / Travel

Travel for this role will be <5%. The physical demands of this job are consistent with a laboratory/bench setting. 

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in a lab. 

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Scientist, Genome Engineering - Discovery Technologies
Function:
Discovery Biologics
Location:
New York, NY
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

Position Summary:
The Scientist in the Genome Engineering Group, Discovery Technologies, will be joining a large and dynamic group focused on executing experiments on the cutting edge of pharmaceutical sciences. This individual will execute experiments needed to support the various research programs for identified targets. They will be required to perform various molecular biology techniques including CRISPR, siRNA, basic cloning and other related genetic modifications to test specific target expression and activity.  They will also be encouraged to develop their own ideas and contribute these to the broader group. The candidate is expected to be a dynamic and motivated scientist who can drive their own experiments and research activities, while collaborating extensively with the rest of the organization to execute on various research programs.
 
Roles and Responsibilities of the Position:
  • Scientific roles and responsibilities
  • Extensive expertise with molecular biology techniques
  • Support R&D projects across Loxo at Lilly with various genome engineering approaches
  • Employ various molecular biology techniques to genetically modify cell lines and organoids
  • Deep knowledge of expression vectors and systems
  • CRISPR for knock in and knock out model generation
  • siRNA for genetic manipulation
  • Cell line development including over-expression for imaging experiments, screening and related experiments
  • Perform experiments that modulate target expression in various biological systems including cell lines and organoids.
  • Interrogate experimental conduct of third parties/vendors

  • Additional responsibilities:
  • Communicate results at project team meetings, be involved in the coordination and preparation of presentations
  • Discuss results with technical as well as non-technical personnel
  • Work in cross functional environments via extensive collaboration with other parts of the organization
  • In some cases, direct leadership of a junior scientist may be required
Required Qualifications and Background:
  • BSc. in biological sciences with 5 years of experience or MSc or PhD in biological sciences with 2-3 years of experience
  • Deep expertise in cancer disease states (indications, mutational status, tumor cell drivers)
  • Demonstrated experience in working collaboratively across various scientific disciplines to meet end goals of business
  • Excellent communication and interpersonal skills
  • Demonstrated ability to succeed in a fast-paced environment, working on multiple projects with constantly changing priorities and deadlines
  • Excellent written and verbal communication skills
Physical Demands/ Travel:
 
The physical demands of this job are consistent with laboratory setting.
 
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
 
 
Work Environment:
 
This position’s work environment is in a lab. 
 
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Scientist, Molecular Characterization, Discovery Technologies
Function:
Discovery Biologics
Location:
New York, NY
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

The Scientist in the Molecular Characterization Group, within Discovery Technologies, will be joining a dynamic group focused on executing experiments on the cutting edge of pharmaceutical sciences. This scientist will work closely with Project Teams and Discovery Informatics to design studies, execute analyses, and interpret data to support the various research programs for identified targets. The successful candidate is expected to demonstrate expertise with basic molecular techniques as well as various innovative, high throughput, high content molecular platforms profiling DNA, RNA and proteins. The Scientist will also be expected to provide related training to other group members and be responsible for inspecting, calibrating, cleaning the instruments within the facility at Loxo. Finally, this role will be responsible for operationalizing new techniques in collaboration with the Molecular Characterization Team.  In this role, the incumbent will also be encouraged to develop their own ideas and contribute these to the broader group. They are expected to be a dynamic and motivated scientist who can drive their own experiments and research activities, while collaborating extensively with the entire organization to execute on various research programs.
Roles and Responsibilities of the Position
  • Scientific roles and responsibilities:
  • Interact and collaborate with various Discovery functional teams to design and execute studies supporting all projects across the oncology portfolio
  • Work collaboratively with the clinical biomarker team to perform and support retrospective and exploratory efforts for clinical programs
  • Provide quality data and analyses from a variety of high throughput, high content genomic, transcriptomic, and proteomic platforms.
  • Develop and implement novel molecular platforms and applications
  • Work with the entire molecular characterization team to ensure all instrumentation is properly maintained and calibrated
  • Provide scientific expertise on practical implementation of molecular platforms and applications across the entire Loxo organization
  • Proper documentation and archiving of data and analyses.
  • Work interactively with project teams and discovery informatics to interpret data and prepare formal study reports
  • Additional roles and responsibilities:
  • Communicate results via written and oral presentations as needed
  • Discuss results with technical as well as non-technical personnel
  • Extensive cross functional communication and collaboration with internal and external parties
  • Interrogate experimental conduct of third parties/vendors
  • Opportunity to directly lead junior scientists
Required Qualifications and Background
  • BSc. in biological sciences with 5 years of experience or MSc or PhD in biological sciences with 2-3 years of experience
  • Extensive experience with multiple nucleic acid and protein expression platforms, including assay design and development
  • Experience with high content, high throughput laboratory workflows with emphasis on quality and efficiency.
  • Working experience with any of the following platforms: Illumina, Fluidigm, Nanostring, Quanterix, Isoplexis, or Luminex.
  • Demonstrated experience in working collaboratively across various scientific disciplines to meet project goals and timelines
  • Flexibility to adjust priorities over time to meet organizational and scientific goals.
  • Ability to work independently and as an integral part of a larger collaborative team.
  • Demonstrated ability to succeed in a fast-paced environment, working on multiple projects with constantly changing priorities and deadlines
  • Excellent interpersonal, written, and verbal communication skills
  • Knowledge and experience documenting and processing clinical samples.
  • Experience processing, analyzing, and interpreting large biological data sets.
  • Experience with Spotfire data visualization software and pathway analysis tools.
  • Deep understanding of cancer disease states (indications, mutational status, tumor cell drivers)
Physical Demands / Travel

TBD <5%. The physical demands of this job are consistent with working in a lab.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in a lab. 

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Scientist, Organoid Team, Discovery Technologies
Function:
Discovery Biologics
Location:
New York, NY
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

Position Summary:
The Scientist in the Discovery Technologies, Organoid Group, will be joining a large and dynamic group focused on executing experiments on the cutting edge of pharmaceutical sciences. The candidate will execute experiments needed to support the various research programs for identified targets. They will be expected to demonstrate expertise with various organoid and patient derived models, to be able to troubleshoot technical difficulties encountered in organoid growth, and to interrogate the work of third parties/collaborators. The candidate will also be encouraged to develop their own ideas, contribute these to the broader organoid group as well as project teams, and is expected to be a dynamic and motivated scientist who can drive their own experiments and research activities, while collaborating extensively with the rest of the organization to execute on various research programs. The candidate will collaborate with project teams in NYC, Indianapolis, SSF, and Boulder for design and execution of studies, and will work closely with multi-disciplinary teams, providing expertise throughout all stages of the lifecycle of target modulation and validation to advance our portfolio. 
Roles and Responsibilities of the Position
  • Scientific roles and responsibilities
  • Develop key capabilities for the generation of necessary patient-derived organoid models for detailed functional characterization
  • Design and execute studies to profile candidate molecules in organoid systems
  • Troubleshoot technical difficulties encountered in organoid establishment, growth and testing
  • Test biologics or small molecules in organoid tumor models (dose response experiments, profiling, comparing to control compounds)
  • Grow organoids of various types; have extensive knowledge of media and growth factors on organoid development
  • Perform experiments that modulate target expression in organoid systems
  • Interrogate experimental conduct of third parties/vendors

  • Additional responsibilities
  • Communicate results at project team meetings, be involved in the coordination and preparation of presentations
  • Discuss results with technical as well as non-technical personnel
  • Lead, and work collaboratively across multiple laboratory-based functions to establish the mechanisms, phenotypes, and biology of new targets using modern approaches in molecular and cellular biology and biochemistry
  • Work in cross functional environments via extensive collaboration with other parts of the organization
  • In some cases, direct leadership of a junior scientist may be required

Required Qualifications and Background:
  • BS degree in biological sciences with 5 years of experience or MS/PhD in biological sciences with 2-3 years of experience required.
  • Extensive expertise working with organoid models
  • Deep expertise in cancer disease states (indications, mutational status, tumor cell drivers) strongly
  • Demonstrated experience in working collaboratively across various scientific disciplines to meet end goals of business
  • Excellent communication and interpersonal skills
  • Demonstrated ability to succeed in a fast-paced environment, working on multiple projects with constantly changing priorities and deadlines
  • Excellent written and verbal communication skills
Physical Demands/ Travel:
 
The physical demands of this job are consistent with laboratory setting.
 
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
 
 
Work Environment:
 
This position’s work environment is in a lab. 
 
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Scientist, Protein Purification
Function:
Discovery Small Molecule
Location:
San Diego, CA
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

This position offers the opportunity to be part of Loxo’s discovery teams focused on creating novel, highly specific and selective drugs for genetically identified targets. The Scientist, Protein Purification will employ modern cloning methods to support the gene-to-structure pipeline across multiple projects and project teams.  This is an extremely important role where the right person will be able to have a real impact on cutting-edge science, making a real difference in patient’s lives.
Roles and Responsibilities of the Position
  • Provide recombinant protein expression support within a structural biology & enzymology setting.
  • Execute projects in an efficient manner, working within aggressive timelines.
  • Rapidly communicate scientific results and insights to the team.
  • Prepare reports for internal and external purposes including regulatory submissions.
  • Participate and lead project-based and technical team meetings to identify and solve problems, guide work towards project goals, communicate on-going work and progress, and plan forward thinking strategies.
  • Continually advance your understanding of current methodology and new/emerging technologies by reading scientific literature.
  • Proactively investigate new or different technologies, methods, and service providers to ensure our work is being done in a scientifically sound, efficient, and reasonable way.
Required Qualifications and Background
  • BA/BS/MS/PhD in biology, genetics, biochemistry, molecular biology or a related field.
  • Ideal candidate will have with 5+ years hands-on experience, working in a gene to structure laboratory in a biotech/pharma setting, but less experienced, motivated individuals are encouraged to apply.
  • Expertise with FPLC protein purification techniques such as IMAC, SEC, IEX, HIC is required, ideally utilizing the Akta FPLC systems.
  • Expertise with protein characterization techniques such as Mass Spectrometry (Orbitrap, QTOF, hybrid traps) and Thermal Denaturation assays such as differential scanning fluorimetry (DSF) is highly desirable.
  • Familiarity with biophysical techniques such as SPR, ITC, Fluorescent binding assays, enzyme kinetic assays is desirable.
  • Experience with a variety of protein expression systems (E.coli, BV, mammalian, yeast) as well as modern cloning technologies e.g. Gibson assembly, gBlock utilization is a plus.
  • The candidate must be self-motivated but always maintain focus on why we are here and who is important i.e. the patients and their families/caregivers.
  • Excellent interpersonal skills with ability to communicate and interact well with colleagues, vendors, contractors, scientific advisors, and staff at all levels.
  • Desire to cross-train and flex between sub-groups (protein expression/purification/characterization) is a must.
  • Highly organized with excellent analytical, documentation and multi-tasking skills.
  • Experience across the gene-to-structure pipeline is a plus.
Physical Demands / Travel

The physical demands of this job are consistent with light office duties.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office and the lab. 

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Scientist/Senior Scientist, Pharmacology
Function:
Pharmacology
Location:
Indianapolis, IN
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

The Pharmacology Scientist will be responsible for identifying, developing, and performing robust, reproducible in vitro and in vivo assays to support tier 1-3 assays.  The Scientist will provide hands-on compound testing to support the small molecule drug discovery oncology pipeline and will be responsible for characterizing the effects of small molecule compounds on specific protein targets using multiple assay formats. A strong background in experimental curve-fitting, statistics, and assay optimization and execution is required.
Roles and Responsibilities of the Position
  • Develop robust Tier 1 - 3 assays including biochemical (enzyme and binding), cell based (e.g. target inhibition, proliferation etc), tumor models (development and analysis).
  • Design, execute, and trouble-shoot experiments.
  • Perform comprehensive data analysis.
  • Communicate experimental findings to team members.
  • Actively engage in advancing drug discovery.
  • This is a “hands-on” laboratory based position.
Required Qualifications and Background
  • BS/MS/PhD in oncology, biology, biochemistry or related fields.
  • Ability to leverage multiple assay platforms to measure target engagement, pathway modulation and cell sensitivity in response to compounds.
  • Strong understanding of oncology and signaling pathways.
  • Continual learner and possesses a can-do attitude.
  • Excellent oral and written communication skills including experimental documentation.
  • Ability to multi-task and shift priorities rapidly to meet tight deadlines.
  • Possess personal accountability for excellent and timely results.
  • Highly organized with exceptional attention to detail.
  • Demonstrate ability and willingness to work effectively in a highly collaborative research environment.
  • Proficient in Microsoft Office suite and applications.
  • Experience with biochemical and kinetic-based assay technologies (e.g. FP, TR-FRET, AlphaScreen, Luminescence).
  • Experience with laboratory instrumentation and automation.
  • Cell culture expertise (cell lines and primary cells) including clonal cell isolation techniques. Solid and liquid tumor cell lines.
  • Hands-on experience in lentivirus production, titration, and transduction.
  • Demonstrated experience in developing cell-based assay to monitor protein levels and modifications including the following methods:   ELISA, In-Cell Westerns, Mesoscale, HTRF, AlphaScreen, MALDI-TOF MS.
  • Cell viability, proliferation and apoptosis assays.
  • Experience with multiplexed antibody-based detection methods (e.g. Luminex, Mesoscale).
  • Tumor and/or tissue sample handling and processing for biomarker analysis.
  • Ability to perform quantitative data analysis, curve fitting, statistics etc.
  • Experience developing multi-channel flow cytometry based screening assays including sample preparation, staining, operating flow cytometers, and analyzing flow.
  • Tumor biology including cell line xenograft and/or PDX models in oncology setting.
Additional Preferred Qualifications
  • Metabolite analysis in cells and tumors.
  • Experience with small molecule compound testing.
  • Proficient in CRISPR, shRNA and/or siRNA gene regulation.
  • Organoid or 3D culture method development.
  • Colony formation assay experience.
  • High content cellular imaging skills.
  • Expertise in running high-throughput and automated cancer cell proliferation panels.
  • Experience in confocal microscopy.
  • Gene expression profiling of tumor samples.
  • Experience in the generation and analysis of mouse cancer models.
  • Experience with tumor implantation techniques and dosing, tumor measurement, health monitoring, and data collection and analysis.
  • In vitro and ex vivo experience analyzing biomarkers (examples include flow cytometry, IHC, ELISA, RT-PCR, Westerns, Luminex).
  • Experience with bioluminescent imaging studies.
  • Understanding of PK, PD, and PK/PD relationship.
Physical Demands / Travel

The physical demands of this job are consistent with a laboratory setting.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office and a lab. 

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Scientist/Senior Scientist, Toxicology
Function:
Toxicology
Location:
Boulder, CO
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

The Toxicologist will be responsible for the planning, execution, and monitoring of DMPK and toxicology studies for advancing candidates through early target assay development, lead optimization, candidate selection and into IND-enabling studies and beyond.
Roles and Responsibilities of the Position
  • Evaluate new targets for potential toxicological liabilities.
  • Create novel experimental designs for mechanistic toxicology studies, including DMPK considerations, designed to assess hypotheses for and evaluate mechanisms of toxicity related to physiological or biochemical functions.
  • Support predictive toxicology experimental efforts within Discovery (e.g., in vitro cell-culture based, animal models of disease) analyze safety-related data and use it to make decisions.
  • Develop early safety assessment and ensure appropriate toxicology studies and liability screens are performed to support nomination of drug candidates for further development.
  • Communicate results clearly and concisely in both oral and written reports and presentations.
  • Perform in depth pathway/network analysis on data derived from toxicology and other studies and disseminate results to the wider toxicology community (internally and externally).
  • Closely interact with scientists in other functional areas.
Required Qualifications and Background
  • Ph.D. in toxicology is required, along with 5+ years’ experience as a toxicologist within the biopharmaceutical industry. Board certification in Toxicology preferred.
  • Previous small molecule oncology therapeutic product development experience in a pharmaceutical or biotechnology company is preferred.
  • Familiarity with GLP regulations and regulatory guidelines for the testing of biopharmaceutical products and experience with compilation of toxicology information into various regulatory submission documents is desirable. 
  • Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
  • Strong written and oral communication skills.
  • Ability to multi-task and shift priorities rapidly to meet tight deadlines.
  • Excellent written and verbal communicator.
  • Detail oriented and well organized.
  • Good and thoughtful listener.
  • Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.
  • Proficient in Microsoft Office suite and applications.
Physical Demands / Travel

The physical demands of this position are consistent with working in an office / laboratory/ environment. Some light lifting, and maneuvering may be required.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office and lab with some remote responsibilities.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Senior Clinical Scientist
Function:
Clinical Science
Location:
South San Francisco, CA
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

This position offers the opportunity to participate in the entire spectrum of the drug development process. We design our drugs “from the ground up”, starting with the selection of a target we hypothesize is critical for cancer survival and producing a highly potent and specific inhibitor of that single target. In your role, you will have the opportunity to move this drug “from the bench to the bedside”, from initial planning of the first-in-human clinical trial to the pivotal studies necessary to prove its clinical efficacy and gain regulatory approval. You will participate directly in improving the lives of people fighting their cancers.

In your role, you will team with the medical monitor and other team members to design, implement execute and analyze results for Phase 1, 2 and 3 clinical trials for ultimate culmination in clinical study reports and NDA/MAA submissions. Excellent communication skills are important, as you will interact with a variety of collaborators, including colleagues, outside consultants, clinical research sites, and key opinion leaders.

We are a small company, but we are highly focused on clinical and regulatory execution. As a key member of our team, you will have the opportunity to work and learn in a fast-paced, team-oriented and exciting work environment that will literally change the lives of cancer patients for the better.

The Senior Clinical Scientist will help translate preclinical discoveries into developing the next generation of cancer therapies and will be responsible for the design, implementation, and monitoring of clinical development programs. These programs include early proof of concept through registration in a variety of targets and may involve collaborations with corporate development partners. Responsibilities encompass strategic planning to ensure optimized clinical development plans for assigned projects. This person must be interested in working in a fast-paced, team-oriented environment and be adaptable to rapidly changing priorities. 
Roles and Responsibilities of the Position
  • Serve as the clinical science representative on global and regional clinical execution teams.
  • Create and foster strong strategic partnerships with colleagues that include Clinical Operations/Development, Global Regulatory Affairs, Clinical Pharmacology, Statistics, Medical Affairs, Data Management and pre-Clinical Development. 
  • Lead the design and interpretation of clinical trials. 
  • Assist in the writing and/or development of protocols, informed consent forms, case report forms, Statistical Analysis Plans, Data Management plans, clinical study reports and regulatory-related documents.
  • Assistance in the development of abstracts, manuscripts, study/program design and presentations; collaborate with external consultants as needed.
  • Review, interpret, and present clinical data from development program and the relevant literature at relevant scientific meetings.
  • Support the writing of subsequent regulatory briefing documents.
  • Lead and accountable for interpretation of interim data analyses, clinical data review, and preparation of dose escalation meetings.  
  •  Demonstrate substantial and relevant knowledge of scientific and medical literature in oncology and its application to strategic design and operational achievements.
  • Along with Clinical Operations, work closely and liaise regularly with clinical sites and investigators to oversee study enrollment and success in clinical trials.
  • Apply scientific and operational knowledge to identify and analyze problems and information of considerable complexity and implement effective plans and solutions.
  • Ability to prioritize effectively and meet multiple deadlines successfully with attention to detail, setting high performance standards.
  • Proactively generate ideas for improvements and take action to solve problems and achieve goals beyond what is required.
Required Qualifications and Background
  • PhD, PharmD or M.D.
  • The ideal candidate will have 5 years of biopharma experience in an academic or industry setting and at least 2+ years’ medical/clinical scientist experience in oncology. At least 5 years’ clinical research experience preferred, particularly in drug development in oncology.
  • Clinical trial expertise along with experience in oncology with drug development highly desirable. Must possess a strong background in clinical trials in an academic or industry setting.
  • Extensive academic/industry experience in laboratory-based cancer research or clinical trials is preferred.
  • The skills required for success in the job include scientific and analytic ability, ability to think strategically and tactically, an interest in applied clinical research, an ability to work effectively in multifunctional teams and excellent organizational and communication skills.
  • The candidate must demonstrate proven ability to evaluate, interpret and present complex scientific data to both technical and non-technical audiences.
  • Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
  • Strong communication skills both written and oral.
  • Ability to multi-task and shift priorities rapidly to meet tight deadlines.
  • Professional demeanor and appearance and an excellent written and verbal communicator.
  • Detail oriented and well organized.
  • Good and thoughtful listener.
  • Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.
  • Proficient in Microsoft Office suite and applications.
Physical Demands / Travel

The physical demands of this job are consistent with light office duties.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.
 


*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Senior Medical Monitor (Multiple Locations)
Function:
Medical
Location:
Stamford, CT
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

The Senior Medical Monitor will lead and support the expansion of clinical development programs (or one large, complex program) in support of the overall product development plan and serve as an ambassador and resource to various physicians and clinical trial sites, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, Loxo customers, markets, business operations, and emerging issues, and perform other responsibilities as requested.
Roles and Responsibilities of the Position
  • Primary responsibility for and ownership of design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents.   
  • May participate in or lead clinical development contributions to due diligence or other business development activity.  As required by program needs, contributes in partnership with research colleagues to design and implement translational strategies.
  • Acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
  • Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. May represent Loxo at key external meetings.
  • Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions.
  • Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research. 
Required Qualifications and Background
  • MD, Board certification in Oncology or equivalent.
  • PhD would be an advantage.
  • 1+ years Clinical Trials/Research experience in pharmaceutical industry, academia, or equivalent.
  • Ability to exercise judgment and address complex problems and create solutions for one or more projects.
  • Ability to develop collaborative working relationships with physicians, expert consultants, and contracted vendors.
  • Strong analytical mind and problem-solving skills, attention to detail, strong organizational skills, and ability to work independently and as part of a team.
  • Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be able to lead through influence.
  • Proven ability to interact externally and internally to support a global scientific and business strategy.
  • Strong document management skills, including proficiency with MS Word, EndNote, PowerPoint and Excel.
  • Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
  • Strong communication skills both written and oral.
  • Ability to multi-task and shift priorities rapidly to meet tight deadlines.
Available locations for this role
  • South San Francisco, CA
  • Stamford, CT
Physical Demands / Travel

The physical demands of this job are consistent with light office duties. This role will require 50-60% travel.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office / traveling in the field to both US and International locations.  

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Senior Medicinal Chemist
Function:
Discovery Small Molecule
Location:
San Diego, CA
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

Loxo Oncology at Lilly’s Drug Discovery team has an immediate opening for an experienced medicinal chemist. The Loxo Oncology at Lilly team’s mission is to invent life-changing targeted therapies for cancer patient populations that are poorly treated by existing therapies. To that end, we have built a multi-disciplinary team of dedicated drug discovery scientists who are passionate about driving the science forward to create highly selective drugs for known oncogenic drivers. We are currently looking for accomplished medicinal chemists with a proven track records of success in small molecule drug discovery. The ideal candidate will be passionate about leading from the bench to solve medicinal chemistry challenges and will excel at working closely with scientists across disciplines. The position requires excellent people skills, a positive can-do attitude, and the ability to thrive in a highly interactive, fast-paced, team environment.
*Roles and Responsibilities for the Position
  • Drive the team forward with new medicinal chemistry analogs that consistently move the project toward the next breakthrough drug candidate.
  • Optimize lead series for potency, selectivity, physiochemical properties, in vitro ADME, and PK by coupling multivariant SAR analysis with hypothesis-driven medicinal chemistry design principles. Use sound scientific methods to propose hypotheses and determine next steps even with complex or ambiguous data.
  • Work closely with structural biology and computational chemistry colleagues to design novel compounds and hypotheses that address key drug optimization goals.
  • Reduce ideas to practice in the lab quickly by effectively employing a broad range of modern organic chemistry transformations, synthetic methods, purification and characterization techniques.
  • Synergize with the broader team by communicating results, sharing insights, making plans, and setting goals in an open, honest way.
  • Provide medicinal chemistry insight for new target and lead identification and evaluation initiatives in the oncology space.
  • Proactively investigate new or different technologies to improve the effectiveness of the drug discovery process.
Required Qualifications and Background
  • B.S., M.S. or Ph.D. in Chemistry with a focus on synthetic organic chemistry.
  • 5+ years of experience in small molecule drug discovery in a biotechnology or pharmaceutical setting.
  • Proven track record of success in advancing programs from leads to advanced candidates.
  • Extensive experience in lead compound optimization for potency, selectivity, ADME and PK.  
  • Experienced in the use of synthetic chemistry instrumentation: HPLC, LC-MS, NMR, and purification systems.
  • Expert in using common medicinal chemistry software: electronic notebook, ChemDraw, Excel; data visualization; structure viewing; literature, chemical and database searching.
  • Committed to staying current with the latest scientific breakthroughs in the medicinal chemistry field through continued reading of the literature and attendance of scientific conferences. 
  • An excellent team player with ability to communicate synergistically with a multidisciplinary team and be accountable for the medicinal chemistry progress of the project. Highly organized with excellent analytical, documentation, time management, and multi-tasking skills.
*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Senior Medicinal Chemist
Function:
Discovery Small Molecule
Location:
Boulder, CO
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

Loxo Oncology at Lilly’s Drug Discovery team in Boulder, Colorado has an immediate opening for an experienced medicinal chemist. The Loxo Oncology at Lilly team’s mission is to invent life-changing targeted therapies for cancer patient populations that are poorly treated by existing therapies. To that end, we have built a multi-disciplinary team of dedicated drug discovery scientists who are passionate about driving the science forward to create highly selective drugs for known oncogenic drivers. We are currently looking for accomplished medicinal chemists with a proven track records of success in small molecule drug discovery. The ideal candidate will be passionate about leading from the bench to solve medicinal chemistry challenges and will excel at working closely with scientists across disciplines. The position requires excellent people skills, a positive can-do attitude, and the ability to thrive in a highly interactive, fast-paced, team environment.
Roles and Responsibilities of the Position
  • Drive the team forward with new medicinal chemistry analogs that consistently move the project toward the next breakthrough drug candidate.
  • Optimize lead series for potency, selectivity, physiochemical properties, in vitro ADME, and PK by coupling multivariant SAR analysis with hypothesis-driven medicinal chemistry design principles. Use sound scientific methods to propose hypotheses and determine next steps even with complex or ambiguous data.
  • Work closely with structural biology and computational chemistry colleagues to design novel compounds and hypotheses that address key drug optimization goals.
  • Reduce ideas to practice in the lab quickly by effectively employing a broad range of modern organic chemistry transformations, synthetic methods, purification and characterization techniques.
  • Synergize with the broader team by communicating results, sharing insights, making plans, and setting goals in an open, honest way.
  • Provide medicinal chemistry insight for new target and lead identification and evaluation initiatives in the oncology space.
  • Proactively investigate new or different technologies to improve the effectiveness of the drug discovery process.
Required Qualifications and Background
  • B.S., M.S. or Ph.D. in Chemistry with a focus on synthetic organic chemistry.
  • 5+ years of experience in small molecule drug discovery in a biotechnology or pharmaceutical industry setting.
  • Proven track record of success in advancing programs from leads to advanced candidates.
  • Extensive experience in lead compound optimization for potency, selectivity, ADME and PK.  
  • Experienced in the use of synthetic chemistry instrumentation: HPLC, LC-MS, NMR, and purification systems.
  • Expert in using common medicinal chemistry software: electronic notebook, ChemDraw, Excel; data visualization; structure viewing; literature, chemical and database searching.
  • Committed to staying current with the latest scientific breakthroughs in the medicinal chemistry field through continued reading of the literature and attendance of scientific conferences. 
  • An excellent team player with ability to communicate synergistically with a multidisciplinary team and be accountable for the medicinal chemistry progress of the project. Highly organized with excellent analytical, documentation, time management, and multi-tasking skills.
Physical Demands / Travel

The physical demands of this position are consistent with working in a laboratory/ bench environment. Some light lifting and maneuvering may be required.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is based in a laboratory/ bench environment.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Senior Principal Scientist, Discovery Biology, Team Leader
Function:
Target Discovery
Location:
South San Francisco, CA
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

The Senior Principal Scientist, Discovery Biology, Team Leader will be responsible for leading a research team identifying the next generation of molecular targets for cancer therapeutics. The Senior Principal Scientist, Discovery Biology, Team Leader will lead the discovery and early validation of oncology targets through close collaborations with other discovery and translational functions. Experience in molecular biology, cell engineering, and biochemistry through in vitro and in vivo model systems is required. In addition, candidates should be familiar with computational and data-driven tools mining large-scale datasets. The Discovery Biology team will be part of a multi-disciplinary effort focused on high-quality, truth-seeking science to bring forward innovative cancer drug therapy.
Roles and Responsibilities of the Position
  • Lead cross-functional teams that will be responsible for novel target discovery and validation.
  • Supervise and mentor cell biologists and biochemists engaged in target identification and validation to think deeply and work creatively while delivering excellent scientific results and insights to the project teams and their colleagues.
  • Develop and continually advance internal drug development efforts through our discovery, clinical and research programs.
  • Proactively investigate new or different technologies and methods to advance our discovery projects.
  • Collaborate closely with leaders across Loxo Oncology at Lilly to identify, validate and advance new targets into portfolio.
Required Qualifications and Background
  • PhD in Molecular/Cellular Biology, Biochemistry, or related field.
  • Minimum of 5-8 years postdoctoral and/or research experience with prior experience in target discovery/validation and cancer biology in the biotech or pharma setting.
  • Deep experience in areas of cancer biology, molecular biology, biochemistry, and cancer genomics.
  • Outstanding communication, writing, and presentation skills is a must.
Additional Preferred Qualifications
  • Demonstrated experience supervising scientists.
  • Expertise in designing and commissioning studies using cancer cell line and patient-derived xenograft models, to test oncology compounds.
  • Experience with cell engineering such as knock-in and knockdown cell lines with CRISPR and/or other technologies.
  • Experience working with external CROs (for PDX models, target screening, etc.).
  • Experience with early clinical trial studies and the development and implementation of pharmacodynamic and patient selection biomarker assays.
  • Highly organized with excellent analytical, documentation and multi-tasking skills.
  • Provide strategic input to target identification and validation strategy to leadership team.
  • Ability to collaborate, lead, and influence others.
Physical Demands / Travel

The physical demands of this job are consistent with light office duties and some laboratory work. Some light lifting, and maneuvering may be required.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office and laboratory environment.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Senior Principal Scientist, Discovery Biology, Team Leader
Function:
Target Discovery
Location:
New York, NY
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

The Senior Principal Scientist, Discovery Biology, Team Leader will be responsible for leading a research team identifying the next generation of molecular targets for cancer therapeutics. The Senior Principal Scientist, Discovery Biology, Team Leader will lead the discovery and early validation of oncology targets through close collaborations with other discovery and translational functions. Experience in molecular biology, cell engineering, and biochemistry through in vitro and in vivo model systems is required. In addition, candidates should be familiar with computational and data-driven tools mining large-scale datasets. The Discovery Biology team will be part of a multi-disciplinary effort focused on high-quality, truth-seeking science to bring forward innovative cancer drug therapy.
Roles and Responsibilities of the Position
  • Lead cross-functional teams that will be responsible for novel target discovery and validation.
  • Supervise and mentor cell biologists and biochemists engaged in target identification and validation to think deeply and work creatively while delivering excellent scientific results and insights to the project teams and their colleagues.
  • Develop and continually advance internal drug development efforts through our discovery, clinical and research programs.
  • Proactively investigate new or different technologies and methods to advance our discovery projects.
  • Collaborate closely with leaders across Loxo Oncology at Lilly to identify, validate and advance new targets into portfolio.
Required Qualifications and Background
  • PhD in Molecular/Cellular Biology, Biochemistry, or related field.
  • Minimum of 5-8 years postdoctoral and/or research experience with prior experience in target discovery/validation and cancer biology in the biotech or pharma setting.
  • Deep experience in areas of cancer biology, molecular biology, biochemistry, and cancer genomics.
  • Outstanding communication, writing, and presentation skills is a must.
Additional Preferred Qualifications
  • Demonstrated experience supervising scientists.
  • Expertise in designing and commissioning studies using cancer cell line and patient-derived xenograft models, to test oncology compounds.
  • Experience with cell engineering such as knock-in and knockdown cell lines with CRISPR and/or other technologies.
  • Experience working with external CROs (for PDX models, target screening, etc.).
  • Experience with early clinical trial studies and the development and implementation of pharmacodynamic and patient selection biomarker assays.
  • Highly organized with excellent analytical, documentation and multi-tasking skills.
  • Provide strategic input to target identification and validation strategy to leadership team.
  • Ability to collaborate, lead, and influence others.
Physical Demands / Travel

The physical demands of this job are consistent with light office duties and some laboratory work. Some light lifting, and maneuvering may be required.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office and laboratory environment.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Senior Principal Scientist, Flow Cytometry Lead, Discovery Technologies
Function:
Discovery Biologics
Location:
New York, NY
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

The leader of the Flow Cytometry Group, Discovery Technologies will be joining a dynamic group focused on executing experiments on the cutting edge of pharmaceutical sciences. This individual will be responsible for overseeing the flow cytometry core group where they will deliver flow data, and support the various research programs for identified targets. They will be expected to demonstrate expertise with flow cytometry experiments (multi color flow cytometry, cell sorting), as well provide flow cytometry training to other group members. The leader of the Flow Cytometry Group will be responsible for oversight of the flow cytometry facilities at Loxo including instrument maintenance and related upgrades. They will also be encouraged to develop their own ideas and contribute these to the broader group. The leader is expected to be a dynamic and motivated scientist who can drive their own experiments and research activities, while collaborating extensively with the rest of the organization to execute on various research programs.
Roles and Responsibilities of the Position
  • Scientific roles and responsibilities:
  • Oversee the flow cytometry facility and staff
  • Design and execute studies using flow cytometry; oversee experimental designs and execution
  • Undertake multi color flow cytometry and cell sorting experiments
  • Provide flow cytometry training to other group members as needed and desired
  • Work collaboratively with the clinical biomarker team to perform to support retrospective and exploratory efforts for clinical programs
  • Oversee equipment in the flow cytometry group, including maintenance and upgrades as needed
  • Provide scientific expertise on flow cytometry to rest of R&D organization
  • Interrogate experimental conduct of third parties/vendors
  • Train and oversee junior scientists in the flow cytometry core
  • Additional responsibilities:
  • Communicate results at project team meetings, be involved in the coordination and preparation of presentations
  • Discuss results with technical as well as non-technical personnel
  • Work in cross functional environments via extensive collaboration with other parts of the organization
  • Report results in formal documents for internal and external submission
  • Maintain meticulous and accurate laboratory notebooks with timely entries
Required Qualifications and Background
  • PhD in biological sciences with 3-5 years of experience, preferably in a pharmaceutical company or biotech and/or leading a core flow cytometry facility
  • Extensive expertise in flow cytometry work with at least 12 color panels
  • Ability to establish flow panels to address portfolio programs (heme and solid tumor cell surface markers, intracellular protein staining)
  • Strong expertise in data analysis (FlowJo, FACS Diva etc..)
  • Deep expertise in cancer disease states (indications, mutational status, tumor cell drivers)
  • Demonstrated experience in working collaboratively across various scientific disciplines to meet end goals of business
  • Leadership experience in a flow cytometry lab
  • Excellent communication and interpersonal skills
  • Demonstrated ability to succeed in a fast-paced environment, working on multiple projects with constantly changing priorities and deadlines
  • Excellent written and verbal communication skills
Physical Demands / Travel

TBD <5%. The physical demands of this job are consistent with working in a lab.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in a lab. 

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Senior Principal Scientist/Fellow, Enzymology
Function:
Discovery Small Molecule
Location:
Boulder, CO
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

Loxo Oncology at Lilly has an opening for an expert enzymologist. The Drug Discovery team’s mission is to invent life-changing targeted therapies for cancer patient populations that are poorly treated by existing therapies. The position requires strong drug discovery experience in order to help guide the design and execution of enzyme screening strategies, mechanism of action, and target engagement studies. 
Roles and Responsibilities
  • Provide enzymology expertise and guidance to project teams
  • Develop strategies to address covalent inhibitor in enzyme and cellular assays
  • Design and execution of enzyme screening strategies, mechanism of action, and target engagement studies across the portfolio
  • Manage a team of biochemists
Required Qualifications
  • Degree in Biochemistry, Chemistry, Biophysics, or related field
  • Ph.D. with > 8 years pharmaceutical, biotech or related industrial experience
  • 5+ years of experience   in covalent inhibitor drug discovery development
Preferred Background
  • An experienced scientist with extensive expertise in enzymology
  • Expertise in enzyme mechanism characterization for reversible and irreversible inhibitors
  • Highly talented and innovative scientist
  • Extensive knowledge of assay development, mechanism-of-action studies, enzyme characterization, kinetics, and protein biochemistry is required.
  • Strong troubleshooting, organization, and planning skills
  • Experience working on structure-driven projects is a plus.
  • Experience with general biochemical and kinetic-based assay technologies (e.g. FP, TR-FRET, AlphaScreen, Luminescence)
  • Experience leading, mentoring, supervising, and developing scientific staff 
  • Strong background in kinetic analysis and mechanistic modelling
  • Demonstrate ability and willingness to work effectively in a highly collaborative research environment.
  • Excellent oral and written communication skills including experimental documentation
  • Strong publication record
Physical Demands / Travel
The physical demands of this job are consistent with a lab.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment
This position’s work environment is in a lab. 

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.


*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Senior Principal Scientist/Principal Scientist, Large Molecule Biology, Team Leader
Function:
Discovery Biologics
Location:
New York, NY
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

The Senior Principal Scientist/Principal Scientist will lead a dynamic group of scientists (internal team as well as external CRO) conducting various research projects to identify large molecule/biologics which can effectively treat various forms of cancer.  This is a hands-on role where you will lead from the bench.  The Senior Principal Scientist/Principal Scientist will design and perform experiments that determine the efficacy of pipeline agents through a variety of techniques such as in vitro and ex vivo assays, target validation, and functional screening. Collaboration across functional areas within Loxo Oncology at Lilly is required including Large Molecule and Oncology Biologics senior leadership.  The Senior Principal Scientist/Principal Scientist will be a key member of the large molecule organization, where you will be responsible for maintaining the scientific quality and efficiency of your organization, as well as assist and contribute to the strategic direction of large molecule discovery.
Roles and Responsibilities of the Position
  • Design and oversee the execution of key mechanistic and discovery biology experiments involving diverse oncogenic mechanisms (i.e., tumor indications, signaling, cancer targets, biologic mechanisms of tumor inhibitions).
  • Maintain focus on project deliverables and prioritize experiments and efforts accordingly.
  • Oversee/perform assays to identify the drug candidate evaluate the candidate for clinical testing.
  • Liaise with CROs and vendors to outsource activities, provide input to management team on vendor selection.
  • Provide scientific expertise when determining organizations to strategically partner with.
  • Interrogate experimental conduct of third parties/vendors.
  • Participate in target identification in collaboration with leadership.
  • Build, lead, and manage team of Scientists at various levels.  
  • Indirectly oversee work of third parties/vendors (e.g., CROs).
  • Manage resource allocation effectively.
  • Build roadmaps to execute on specific targets, and overall strategic projects.
Required Qualifications and Background
  • PhD in cellular biology, immunology, or allied disciplines with minimum 3+ years’ industry experience OR BS/MS with 10+ years of direct pharmaceutical/biotechnology experience.
  • Laboratory experience with ADC and CD3 platforms and biologic assays.
  • Knowledge on immune targets and myeloid biology/targets.
  • Strong attention to detail and highly goal oriented with demonstrated critical thinking capabilities.
  • Ability to trouble shoot effectively and think outside of the box.
  • Ability to collaborate with translational biology functions (PK/PD, toxicology, Ab discovery).
  • Proven success leading, managing, and coaching others (either directly or indirectly).
  • Demonstrated ability and track record in managing work overseen by third parties/vendors/strategic partners.
  • Demonstrated experience in working collaboratively across various scientific disciplines to meet end goals of business.
  • Demonstrated excellence in making key strategic decisions in support of broader business goals.
  • Excellent written and verbal communication skills.
Physical Demands/ Travel:
 
The physical demands of this job are consistent with laboratory/bench setting
 
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
 
 
Work Environment:
 
This position’s work environment is in a lab.  
 
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Senior Scientist, Translational Medicine
Function:
Translational Medicine
Location:
South San Francisco, CA
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

With strong background in biochemistry and small molecule drug discovery, the Senior Scientist, Translational Medicine will support lab-based research projects associated with Loxo Oncology at Lilly’s preclinical and early development programs. This entails independently planning and executing experiments focused on understanding protein-protein and protein-small molecule interactions utilizing biochemical and biophysical techniques. 
Roles and Responsibilities of the Position
  • Establish robust biochemical and biophysical assays to study protein-protein and protein-small molecule interactions including HTRF, AlphaLISA, SPR (surface plasmon resonance), affinity purification, co-immunoprecipitation, chemical cross-linking, mass spectrometry, and CETSA.
  • Design and execute cross-assay validation studies.
  • Analyze and interpret data, with ability to troubleshoot assays.
  • Organize and coordinate multiple projects in parallel.
  • Identify, evaluate, and manage vendors for outsourced services and studies.
  • Prepare and present scientific results at congresses and in peer-reviewed journals.
Required Qualifications and Background
  • PhD in in biology, molecular biology, cell biology, biochemistry or related discipline, with 3+ years lab-based experience in a biotech/pharma setting.
  • Proven track record in design and development of state-of-the-art biochemical and biophysical methods to study protein-protein, protein-small molecule interactions and protein turnover.
  • Hands-on experience in protein construct design, protein expression and purification, and mammalian cell culture.
  • Self-organized, detail-oriented, self-directed, highly motivated with strong critical thinking and analytical skills.
  • Willingness to work collaboratively and incorporate diverse perspectives into decision-making.
  • Demonstrated ability to work successfully in a nimble, fast-paced matrixed environment.
Physical Demands / Travel

The physical demands of this job are consistent with working in a laboratory/ bench environment. Some light lifting, and maneuvering may be required.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in a laboratory/bench environment.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Senior Statistical Programmer
Function:
Biostatistics
Location:
South San Francisco, CA
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

The Statistical Programmer is responsible for providing Statistical Programming activities across in support of one or more clinical stage programs. Responsibilities will include: support of workflow in generation of study-specific and ad-hoc clinical data listings, summary tables and figures; performing data analysis, statistical analysis, generate safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
Roles and Responsibilities of the Position
  • Perform data analysis using primarily the SAS programming language for the summary and interpretation of clinical trial data.
  • Create and review CDISC, SDTM and ADaM files, SAS export files and Define.xml use for Electronic Submission from the data received in non-standard form from various sources.
  • Perform data analysis, statistical analysis, generate safety and efficacy tables, listings, and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
  • Develop SAS coding and table templates for preparing, processing and analyzing clinical data.
Required Qualifications and Background
  • Bachelor/Master’s degree in Statistics, Life Sciences, Computer Sciences, or Mathematics with a minimum 3-5 years Pharmaceutical/Biotech programming experience.
  • Experience in the analysis of complex oncology and/or hematology clinical trial data.
  • Solid knowledge of SAS Programming language.
  • Experience with integrated summaries (ISE/ISS) and Clinical Study Reports.
  • Proven ability to work both independently and in a team setting.
  • Strong well-rounded technical skills (EDC systems, MS Word, Excel, PowerPoint).
  • Excellent verbal/written and interpersonal skills.
  • Ability to communicate and collaborate effectively with cross-functional teams in face-to-face conversation, by telephone, and by email
  • Ability to work effectively in a fast-paced environment with a positive “can-do” proactive attitude.
Physical Demands / Travel

This position will travel occasionally based upon the demands of the business imperatives.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is based in a typical office setting.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Senior/Principal Computational Biologist (Multiple Locations)
Function:
Discovery Bioinformatics
Location:
South San Francisco, CA
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

We are seeking a talented and highly motivated experienced Computational Biologist to join our Discovery Bioinformatics group. The candidate will lead bioinformatics efforts across multi-disciplinary teams to rapidly advance small molecule drug development efforts. This position is expected to lead and oversee broader strategic involvement in shaping the next generation of cancer therapies through data-driven approaches.
Roles and Responsibilities of the Position
  • The successful candidate will join a dynamic team and oversee computational biology efforts across multiple functions. They will lead a team, develop scientists, and help build a research strategy that leverages deep cancer biology knowledge and high-dimensional data. Success critically depends on the ability to effectively present complex analyses and results in a clear and concise manner to a diverse audience of scientists.
Required Qualifications and Background
  • PhD in Bioinformatics, Biostatistics, Computational Biology, or similar area of study required. Post-doctoral training or equivalent prior work experience (2-5+ years) is preferred but not necessary if supported by substantial publication record and/or similar achievements.
  • Demonstrated track record of strategic scientific leadership in the computational biology field with leading and developing scientists.
  • Strong understanding of relevant concepts in cancer biology and molecular biology.
  • Experience in large-scale data analyses involving high-throughput molecular assays such as DNA/RNA-Seq, ATAC/CHiP-Seq, single-cell technologies, etc.
  • Understanding of current best-practices for high-throughput genomics/molecular data analyses and familiarity of their underlying statistical principles.
  • Experience using programming languages such as R, Python, or similar for statistical analysis.
Available Locations for this role:
  • South SF, CA
  • New York City, NY
  • US Based-Remote
Physical Demands / Travel:

The physical demands of this job are consistent with light office duties.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment:

This position’s work environment is in an office.  

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Senior/Principal Medical Writer
Function:
Medical Writing
Location:
Remote
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

The Senior/Principal Medical Writer will be responsible for the writing and editing of high-quality, strategically aligned medical writing deliverables that support the clinical development, safety, and regulatory requirements of a clinical program.
Roles and Responsibilities of the Position
  • In collaboration with clinical and regulatory, manages the authoring and document life cycle of clinical protocols and amendments, clinical study reports (CSRs), Investigator’s Brochures (IBs), electronic Common Technical Document (eCTD) summaries and other documents for submission to the Food and Drug Administration (FDA) or other regulatory agencies.
  • Compiles, analyzes, and summarizes data from statistical tables and other sources, as needed.
  • Liaises with cross-functional team members (e.g., clinical operations, clinical science, regulatory affairs, biostatistics, nonclinical) to ensure that information is accurately captured in documents.
  • Coordinates document reviews; schedules and hosts meetings to resolve team comments.
  • Acts as the medical writing representative for a program; may work with medical writing contractors on a program to ensure consistency in messaging across a program.
  • Participates in the development/update of departmental procedures and templates.
  • Other duties as needed.
Required Qualifications and Background
  • BS and at least 4 years of related experience; advanced degree (e.g., MS/PhD/PharmD) may compensate for years of experience.
  • Prior medical technical writing experience within the biotech/pharmaceutical/clinical research organization (CRO) realm.
  • Experience and significant participation in preparation of clinical documents for regulatory submissions (e.g., clinical protocols, Investigational New Drug applications [INDs], New Drug Applications [NDAs], Biologic License Applications [BLAs]).
  • Familiarity with therapeutic area of oncology desirable.
  • Exceptional written and oral communication skills; strong attention to detail.
  • Ability to write and edit complex material to ensure accuracy, clarity, and effectiveness.
  • Knowledge of International Council for Harmonisation (ICH) guidelines for clinical and regulatory submission documents.
  • Expert abilities in Microsoft Office.
  • Ability to work in a fast-paced dynamic environment that involves frequent communication with project team.
  • Excellent time management skills and ability to manage several projects simultaneously.
  • Ability to communicate with cross-functional team members (e.g., clinical development, biometrics, regulatory affairs, quality assurance, manufacturing, nonclinical) and incorporate diverse feedback into a high-quality document.
Physical Demands / Travel

The physical demands of this job are consistent with light office duties.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Senior/Principal Scientist, Discovery Biology
Function:
Target Discovery
Location:
New York, NY
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

The Senior/Principal Scientist, Discovery Biology will be part of the Loxo Oncology at Lilly’s Discovery group identifying the next generation of molecular targets for cancer therapeutics.  The Senior/Principal Scientist, Discovery Biology will be responsible for creating and executing strategies toward discovery and early validation of oncology targets through close collaboration with other discovery and translational functions. The Senior/Principal Scientist, Discovery Biology will have a strong understanding of oncogenic pathways and experience in designing experiments to evaluate molecular interactions and pathways. The Senior/Principal Scientist, Discovery Biology will be part of a multi-disciplinary effort focused on high-quality, truth-seeking science to bring forward innovative cancer drug therapy.
Roles and Responsibilities of the Position
  • Create, develop and validate quantitative mammalian cellular assays to credential novel targets.
  • Establish robust high-throughput screening assays.
  • Design and manage in vivo pre-clinical studies.
  • Conceive and lead collaborative projects on biomarker-driven programs.
  • Evaluate emerging technologies, methods, and service providers to ensure our work is being done in a scientifically sound, efficient, and reasonable way.
  • Collaborate with colleagues throughout the company to ensure assays meet the program needs and results are appropriately interpreted.
  • Participate and thrive in an interactive, team-oriented culture.
  • Directly manage and mentor lab-based staff.
Required Qualifications and Background
  • PhD in Molecular/Cellular Biology or Biochemistry, or related field.
  • Minimum of 3-6 years of postdoctoral and/or hand-on research experience, preferability in biotech/pharma setting.
  • Experience in relevant areas of cancer and molecular biology.
  • Outstanding communication, writing, and presentation skills is a must.
Additional Preferred Qualifications
  • Experience with cell engineering such as knock-in and knockdown cell lines with CRISPR and/or other technologies.
  • Experience with flow cytometry and general molecular biological techniques including q-PCR, signaling experiments, assays for protein-protein interactions and Western Blot etc.
  • Experience in designing and handling in vivo animal studies.
  • Experience in building models (cell line, organoid or PDX) from patient samples and using them to test drug activities.
  • Experience working with external CROs.
  • Excellent interpersonal skills with ability to communicate and interact well with colleagues, vendors, contractors, scientific advisors, and staff at all levels and problem solving skills.
  • Ability to summarize complex experiment and results for non-specialists.
  • Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.
Physical Demands / Travel

The physical demands of this job are consistent with working in a laboratory/ bench environment. Some light lifting, and maneuvering may be required.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in a lab/bench environment.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Senior/Principal Scientist, Discovery Biology
Function:
Target Discovery
Location:
South San Francisco, CA
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

The Senior/Principal Scientist, Discovery Biology will be part of the Loxo Oncology at Lilly’s Discovery group identifying the next generation of molecular targets for cancer therapeutics.  The Senior/Principal Scientist, Discovery Biology will be responsible for creating and executing strategies toward discovery and early validation of oncology targets through close collaboration with other discovery and translational functions. The Senior/Principal Scientist, Discovery Biology will have a strong understanding of oncogenic pathways and experience in designing experiments to evaluate molecular interactions and pathways. The Senior/Principal Scientist, Discovery Biology will be part of a multi-disciplinary effort focused on high-quality, truth-seeking science to bring forward innovative cancer drug therapy.
Roles and Responsibilities of the Position
  • Create, develop and validate quantitative mammalian cellular assays to credential novel targets.
  • Establish robust high-throughput screening assays.
  • Design and manage in vivo pre-clinical studies.
  • Conceive and lead collaborative projects on biomarker-driven programs.
  • Evaluate emerging technologies, methods, and service providers to ensure our work is being done in a scientifically sound, efficient, and reasonable way.
  • Collaborate with colleagues throughout the company to ensure assays meet the program needs and results are appropriately interpreted.
  • Participate and thrive in an interactive, team-oriented culture.
  • Directly manage and mentor lab-based staff.
Required Qualifications and Background
  • PhD in Molecular/Cellular Biology or Biochemistry, or related field.
  • Minimum of 3-6 years of postdoctoral and/or hand-on research experience, preferability in biotech/pharma setting.
  • Experience in relevant areas of cancer and molecular biology.
  • Outstanding communication, writing, and presentation skills is a must.
Additional Preferred Qualifications
  • Experience with cell engineering such as knock-in and knockdown cell lines with CRISPR and/or other technologies.
  • Experience with flow cytometry and general molecular biological techniques including q-PCR, signaling experiments, assays for protein-protein interactions and Western Blot etc.
  • Experience in designing and handling in vivo animal studies.
  • Experience in building models (cell line, organoid or PDX) from patient samples and using them to test drug activities.
  • Experience working with external CROs.
  • Excellent interpersonal skills with ability to communicate and interact well with colleagues, vendors, contractors, scientific advisors, and staff at all levels and problem solving skills.
  • Ability to summarize complex experiment and results for non-specialists.
  • Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.
Physical Demands / Travel

The physical demands of this job are consistent with working in a laboratory/ bench environment. Some light lifting, and maneuvering may be required.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in a lab/bench environment.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Specialist Quality Assurance, GMP (Multiple Locations)
Function:
Quality Assurance
Location:
South San Francisco, CA
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

The Specialist, Quality Assurance - GMP supports Loxo QA. The Specialist, Quality Assurance - GMP will function as a QA Generalist. The Specialist, Quality Assurance-GMP will work closely with Loxo Regulatory, Drug Supply, CMC and the contract organizations those departments are partnering with. The Specialist, Quality Assurance – GMP will also support Document Control by routing SOPs for review/approval in the QMS system at Loxo.
Roles and Responsibilities for the Position:
  • Ensure GMP work at Loxo and contract organizations is done in compliance with applicable laws, regulations, guidelines, and SOPs.
  • Work closely with Loxo QA, CMC, Regulatory, and Drug Supply colleagues through all phases of drug development, particularly early phase to ensure compliance and timeliness of GMP work.
  • Work closely with CMOs to ensure compliance and timeliness of GMP work.
  • Execute all Quality System elements, which include but are not limited to investigation of product complaints, deviations, CAPAs, document creation and control, change control, validation (e.g. analytical method,.), stability, batch record review, and product disposition. 
  • QC IMPD/IND CMC sections.
  • Facilitate documentation reviews with Qualified Persons (QPs)
  • Review and approve labeling.
  • Participate on project teams and sub-teams as needed and assigned.
  • Ensure documents and records are kept in compliance with regulations and SOPs.
  • Routing SOPs for review/approval in the QMS System.
  • Additional tasks as required.
Required Qualifications and Background:
  • BA/BS in science or engineering. 
  • A minimum of 5-7 years of experience working in the Biotech or Pharmaceutical FDA regulated industry in QA or a related area.
  • Experience in Batch Review and Release.
  • Experience writing and reviewing Deviations, CAPAs, and Change Controls.
  • Experience working with solid oral dosage products.
  • Working knowledge of cGMP’s (CFR/ICH) and applicable international regulations/guidelines.
  • Experience working with Contract Manufacturing Organizations.
  • Strong understanding of GMP requirements for early phase drug development.
  • Attention to detail and accuracy of work.
  • Ability to multitask and work in a fast-paced environment to meet tight deadlines.
  • Ability to work in a matrixed environment.
  • Ability to work in a virtual manufacturing environment.
  • Ability tDemonstrated ability to work well with other accomplished professionals.
  • Willing Collaborator
  • Strong communication skills both written and oral.
Available Locations for this role
  • Stamford, CT
  • South San Francisco, CA
  • Boulder, CO
  • Remote (US Based)

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Structural Biologist, Cryo-Electron Microscopy
Function:
Discovery Small Molecule
Location:
San Diego, CA
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

This position offers the opportunity to be part of Loxo’s discovery teams focused on creating novel, highly specific and selective drugs for genetically identified targets.  The scientist will offer structural and mechanistic insights to a multi-disciplinary discovery team by delivering high quality protein structures to advance our knowledge of mechanistic biology.
Roles and Responsibilities of the Position
  • Deliver cryo-EM protein: ligand structures to drug discovery teams utilizing their expertise in the cryo-EM process from construct design through structure refinement and analysis.
  • Coordinate cryo-EM data collection on multiple protein targets.
  • Optimize sample vitrification conditions and collect high magnification data.
  • Analyze cryo-EM data collections including contrast transfer function estimation, particle picking through neural network algorithms, frame alignment, 2D classification, 3D ab-initio reconstructions, 3D classification through heterogeneous refinement, homogeneous refinement, masked local refinement, particle polishing, and 3D variability.
  • Provide scientific expertise to cross-functional project teams  on recent advances and explore the feasibility of experiment proposals.
  • Train scientists in cryo-EM data processing using various state-of-the-art software for 3D reconstructions, atomic model building and in fundamentals of cryo-EM sample handling and preparation.
Required Qualifications and Background
  • Ph.D. or equivalent in structural biology, biophysics, or a related field with postdoctoral/industrial experience in structural biology and 2+ years of documented experience in cryo-EM of proteins.
  • Experience with cryo-EM sample preparation protocols including negative staining and sample vitrification.
  • Experience with operation of Krios microscopes or similar.
  • Experience with cryo-EM software packages for collecting and processing data such as RELION and EMAN2.
  • Experience with software for model building and refinement such as Phenix, CCP4-em, Chimera, Rosetta etc.
  • Experience with Micro-ED, protein crystallography, and protein:ligand mechanistic studies is desired.
  • A true team player with a track record of successful collaborations.
Physical Demands / Travel

The physical demands of this job are consistent with working in a lab.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office and the lab. 

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Study Sample Manager, Discovery Technologies
Function:
Discovery Biologics
Location:
New York, NY
Position Summary:
Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

The Study Sample Manager will be responsible for managing samples and tracking project studies within the Discovery Technologies group.  The Study Sample Manager will work closely with Discovery leaders and team members to establish a seamless workflow from study design to reporting. They will be responsible for monitoring study timelines and progress, as well as sample tracking and downstream processing of oncology research and clinical samples. Establishment, implementation, and maintenance of an integrated tracking system for project samples and data for internal as well as external CRO studies is required.  In addition, the manager will be responsible for establishing SOPs and processes related to storage inventory, preparation of samples for testing, and shipping/receipt of supplies/samples/compounds for internal assays. This individual collaborates with study team leads, discovery technologies group leads, and the discovery informatics group to ensure timely delivery of results. 
Roles and Responsibilities of the Position
  • Establish study templates for projects conducted in the Discovery Technologies group
  • Ensure scientific alignment with Discovery teams and verify clear deliverables and timelines for studies
  • Establish a network of CROs to supplement internal assay platforms and capabilities
  • Establish a tracking system (i.e. LIMS) for oncology research and clinical biomarker samples
  • Manage organized storage of samples, monitor study workflows, and ensure proper communication among all Discovery functional teams. Monitor sample read-outs (raw data and reports generated by the DT organization) to Discovery scientists
  • Coordinate incoming and outgoing sample shipments with external vendors for all Discovery projects, including diligent preparation of all associated documentation, manifests, packing slips, shipping labels, and release documents
  • Support ordering of laboratory supplies and reagents as well as manage receipt and delivery of incoming packages, checking for expired reagents, following up on orders, etc. 
  • Maintenance of compound inventory for short/long term storage, and update sample tracking system with LIMS database
  • Work collaboratively with the clinical biomarker team to support retrospective and exploratory efforts for clinical programs
  • Assist with obtaining quotes for external assays and the coordination of delivery of samples between lab and external vendors
  • Maintain effective oral and written communication to Discovery team members to provide support to ensure timelines, costs and risk assessments are met
  • Maintain accurate and concise inventory of research and clinical/preclinical oncology biomarker samples across drug programs and third-party labs
  • Establishing and maintaining a quality assurance program on testing for clinical samples
Required Qualifications and Background
  • A BS/MS or equivalent degree in chemistry and/or biological sciences with at least 6+years working full time in a laboratory setting either in academia or industry
  • Basic understanding of high content molecular profiling (RNA, DNA) and related techniques desired
  • Knowledge of imaging and flow cytometry techniques
  • Strong organizational skills and attention to detail
  • Ability to work both independently and within a multidisciplinary team.
  • Must have high proficiency in MS Office Suite; experience with project management software is a plus
  • Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment
  • Able to communicate and collaborate effectively with cross-functional teams in face-to-face conversation, by telephone, and by email.
  • Experience using sample management database is preferred
  • Ability to manage, prioritize, and routinely report progress on multiple projects and tasks
Physical Demands / Travel

The physical demands of this job are consistent with working in a lab.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in a lab.   

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Apply Now

Position:
Outstanding Team Member
Reporting To:
Dedicated, Knowledgeable Supervisor
Location:
United States and Beyond
Position Summary

Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by that goal. We pursue this goal with a tenacity, focus and commitment to excellence that defines who we are and how we work.

We seek dedicated, passionate, hardworking intelligent, thoughtful and authentic individuals who thrive within a collaborative and fast-paced environment and will bring their experiences, unique perspectives and problem-solving skills to the team. In return, we cultivate an environment that rewards and recognizes hard work and provides opportunities for learning and growth as part of a team making a meaningful difference in the field of medicine and for individual patients.

If you share our passion, please let us know how you could contribute to our team. We don't want to pass up an opportunity for the right candidate to join us just because you found us before we found you.

Connect With Us

Submit your resume and your "Who", "What" and "Why" (see below) to careers@loxooncology.com.

Your "Who", "What" and "Why":

  • Who are you?
  • What will you bring to Loxo?
  • Why do we need you on the team?

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

For more information about Loxo Oncology’s privacy practice, please view the Privacy Statement.