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.


Reports To:

Associate Director, Accounting

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, South San Francisco, Stamford, CT, and Madrid, Spain.

Managing and overseeing the daily accounting operations of the finance department. Responsible for month-end close activities, analyzing accounting data, executing and maintaining policies and procedures. Review workpapers and ensuring accuracy and completion. Participate in Sarbanes-Oxley (SOX) compliance requirements that include updating documentation and testing of processes including assessments, planning and walk-throughs. Work closely with a cross-functional team and effectively communicate to ensure completion of tasks.

Roles and Responsibilities of the Position*
  • Manage the month-end, quarter-end and year-end accounting close process and ensure process is performed in a timely and accurate manner
  • Perform month-end close activities related to major balance sheet accounts such as Payroll, Related Benefits and Accrued Expenses
  • Prepare and post journal entries and prepare account reconciliations
  • Work directly with HR and Payroll Service to perform payroll activities
  • Responsible for recording accruals related to bonus and PTO along with reconciliations
  • Participate and support the maintenance of Sarbanes-Oxley internal control requirements
  • Monitor internal controls over financial reporting for internal and external purposes
  • Prepare tax documents related to property, sales tax and revenue
  • Post intercompany transactions and reconcile monthly
  • Oversee fixed assets process and research software implementation
  • Review and approve wires, ACH payments and check-runs
  • Evaluate posted vendor invoices for accuracy of input
  • Support internal and external audit requirements related to specific areas of responsibilities and prepare supporting documentation for SEC filings as needed
  • Maintain and update corporate accounting policies and procedures
  • Participate in special projects and perform other related duties as assigned
Required Qualifications and Background
  • Bachelor's degree in Accounting or Finance
  • 6+ years relevant professional experience is required (mix of private and public experience preferred)
  • Pharmaceutical or biotechnology industry experience is required
  • Intercompany transactions and reconciliations experience a plus
  • CPA is preferred
  • Strong understanding of U.S. GAAP accounting and reporting and SOX requirements
  • Strong analytical, problem solving, organizational & project management skills
  • High degree of dedication to improvement and strong sense of ownership
  • Team player, with the ability to work independently and willingness to take on challenges in dynamic environment
  • Excellent written and verbal communication skills, including ability to interact effectively with management team, peers, cross-functional teams and business partners
  • Extensive knowledge and use of Microsoft Excel
  • Experience with SaaS ERP and P2P systems
Physical Demands / Travel

The physical demands of this job are consistent with working in an office/lab. Travel expected to be around 25%.

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 each role and responsibility 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.


Reports To:

Executive Director, Medical Affairs

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, South San Francisco, 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 Breast 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 each role and responsibility 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.


Reports To:

Biophysics Director

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, South San Francisco, 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 Associate Protein Biophysicist 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 each role and responsibility 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.


Reports To:

Senior Director, Discovery Bioinformatics

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, South San Francisco, 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 work with scientists and engineers to facilitate deep exploration of 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 experience in software development, including database designs, maintaining full-stack applications and data pipelines
  • Documented track record delivering and deploying large-scale informatics production solutions in the cloud
  • Familiarity with containerization, RESTful web service development, relational and non-relational databases designs are highly desired
  • Experience with full stack web development with Python, SQL, Javascript or related programming/scripting language
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 each role and responsibility 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.


Reports To:

Biospecimen Manager

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, South San Francisco, Stamford, CT, and Madrid, Spain.

The Biospecimen Coordinator will be responsible for tracking inventory and overseeing the downstream processing of oncology research and clinical biomarker samples.  This individual collaborates with oncology clinical study teams and research teams including Clinical Trial Managers (CTMs), Data Managers, and a network of contract research labs. 

Roles and Responsibilities of the Position*
  • Utilize software tools to track inventory of oncology research and clinical biomarker samples
  • Maintain accurate and concise inventory of research and clinical/preclinical oncology biomarker samples across drug programs and third-party labs
  • Support clinical development teams to design biospecimen handling logistics with preferred vendors
  • Maintain regular metrics of biospecimen activities for studies
  • Track and resolve discrepancies with study team, sites, or CRO vendors within specified time frames
  • Assist in developing biospecimen collection plans with vendors by aligning with the clinical study protocol for sample collection requirements
  • Use monitoring tools to proactively identify trends and provide feedback to internal departments
  • Oversee shipments of biomarker samples from sample repositories to third party labs for testing
Required Qualifications and Background
  • Bachelors’ degree in Life Sciences, health related field or equivalent experience
  • Minimum of 3 years sample management experience in pharmaceuticals, laboratory, or biorepository setting
  • Oncology experience required across all phases of clinical trials
  • Good working knowledge of ICH, FDA, and GCP regulations and guidelines
  • 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
  • Excellent organizational skills with high attention to detail is required
  • Strong computer skills (spreadsheets, word processing, etc.) is required
  • 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 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 each role and responsibility 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.


Reports To:

Senior Director, Biostatistics

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, South San Francisco, 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 each role and responsibility 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.


Reports To:

TBD

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, South San Francisco, 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.
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 each role and responsibility 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.


Reports To:

Associate Director/Director, Clinical Operations

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, South San Francisco, 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.
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 encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility 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.


Reports To:

Associate Director, Clinical Scientist

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, South San Francisco, 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.

Roles and Responsibilities of the Position*

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 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. 

  • 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, Drug Safety, Translational Medicine, 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.
  • Assist 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, detailed 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, NP, or MD
  • 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 appearance, and integrity. 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 each role and responsibility 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.


Reports To:

Associate Director/Director, Clinical Operations

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, South San Francisco, 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.
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 encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility 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.


Reports To:

Associate Director/Director, Clinical Operations

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, South San Francisco, Stamford, CT, and Madrid, Spain.

The Clinical Trial Manager / Senior Clinical Trial Manager, Clinical Pharmacology 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.
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 encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility 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.


Reports To:

Senior Director, Discovery Bioinformatics

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, South San Francisco, 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
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 each role and responsibility 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.


Reports To:

Director, Computational Chemistry

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, South San Francisco, 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 of 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
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 each role and responsibility 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.


Reports To:

TBD

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, South San Francisco, Stamford, CT, and Madrid, Spain.

The DM 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.
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 each role and responsibility 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.


Reports To:

Director, Biomarker Operations

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, South San Francisco, 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.
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 each role and responsibility 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.


Reports To:

Senior Director, Medical Affairs

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, South San Francisco, Stamford, CT, and Madrid, Spain.

The Diagnostics Medical Science Liaison (DxMSL) is responsible for the identification and engagement of targeted groups of regional thought leaders within the pathology, laboratory, and oncology communities with specific responsibility for providing consistent delivery of educational and compliant scientific information surrounding clinical/scientific aspects of cancer diagnosis and biomarker/genomic testing.

Roles and Responsibilities of the Position*
  • Identify and develop relationships with clinical/community/academic thought leaders on a local and regional level.
  • Serve as Loxo Oncology’s scientific representative to the Pathology, Diagnostic and Medical communities and facilitate the appropriate exchange of scientific information.
  • Utilize approved resources to address inquiries, ensuring they are in compliance with all guidelines and regulations.
  • Communicate diagnostic and therapeutic market trends which may impact biomarker/genomic testing.  
  • Participate and support advisory boards and steering committees.
  • Lead and/or participate on committee/project teams which support Diagnostic MSL strategies as delegated by MSL leadership. 
  • Attend identified relevant national/regional/local education meetings and conferences, maximizing opportunities at these events.
  • Develop and implement educational speaker programs for the pathology/lab audience.
  • Educate on high quality comprehensive testing for relevant biomarkers in precision oncology and make ties to Loxo pipeline assets.
Required Qualifications and Background
  • Advanced doctoral degree strongly preferred (e.g. PharmD, MD, DO, or PhD). Candidates with a diagnostic laboratory and or clinical pathology background (e.g. MSN, PA) and extensive hematology/oncology MSL experience will also be considered.
  • 0-3+years’ MSL experience in Oncology or Oncology Diagnostics required
  • Ability to establish and maintain relationships with influential thought leaders.
  • Product launch experience a plus; Laboratory or Clinical Diagnostics experience beneficial.
  • Exceptional interpersonal skills.
  • Ability to excel in dynamic settings with short timelines.
  • Strong written/verbal communication and presentation skills.
  • Proficient in Microsoft Office suite and applications.
Physical Demands / Travel

Please note this role will require up to 50% travel, primarily within assigned region but also nationally and globally as 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 remote based, with significant travel on a regional basis to various sites.

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 each role and responsibility 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.


Reports To:

SVP, Small Molecule Discovery

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, South San Francisco, Stamford, CT, and Madrid, Spain.

Loxo Oncology at Lilly has an immediate opening for an experienced Director of Medicinal Chemistry. 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 accomplished medicinal chemistry professional with a proven track records of success in small molecule drug discovery. The ideal candidate will be passionate about leading from the bench to guide a team of Medicinal Chemists in solving 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*
  • Lead one or more teams of medicinal chemists to drive drug discovery programs from inception to candidate nomination.
  • Empower the medicinal chemists on the team to develop a deep expertise and practical knowledge in all aspects of medicinal chemistry design including structure-based design, multi-variant SAR analysis, selectivity optimization, ADME and PK optimization, and developing robust IP positions. Apply sound scientific methods to propose hypotheses and determine next steps.
  • Apply strategic thinking to advance projects quickly by employing the right strategic focus to solve the unique challenges each project presents.
  • Grow the chemistry team to be highly effective in reducing ideas to practice by employing a broad range of modern organic chemistry transformations, synthetic methods, purification, and characterization techniques.
  • Expand the group’s productivity by effectively leading CRO relationships and proactively investigating new or different technologies to improve the -efficiency of the drug discovery process.
  • Collaborate closely with the other Discovery disciplines to enable project success. Synergize with the broader team by communicating results, sharing insights, making plans, and setting goals in an open, honest way.
  • Champion bringing new classes of targets or new modalities of target inhibition (e.g. degraders) to expand the breadth of our portfolio.
  • Communicate often and well with translational and clinical groups to develop and refine clinically informed, mechanistically grounded Target Product Profiles with a high confidence in providing drugs candidates meaningful benefits to patients.
  • Present project updates that clearly convey progress and challenges to Loxo Leadership and Scientific Advisory Boards in formal and informal settings.
  • Contribute the business development evaluation of in-license opportunities.
  • Synergize with other Loxo Oncology at Lilly leaders on identifying and advancing new targets into the portfolio.  
Required Qualifications and Background
  • A passion for making drugs that can provide a real benefit for patients.
  • Deep expertise in leading small molecule drug discovery programs in a biotechnology or pharmaceutical company setting.
  • Proven track record of success in advancing programs from leads to advanced candidates.
  • Direct management experience leading medicinal chemistry teams.
  • An advanced degree (M.S. or Ph.D.) in synthetic organic chemistry and 12+ years of relevant experience.
  • An excellent leader and 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.
  • Strong passion for growing the organization’s talent and capabilities to stay abreast of new technologies and tackle new targets with the single-minded focus on helping patients.  
Physical Demands / Travel

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

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 and 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 each role and responsibility 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.


Reports To:

Executive Director, Medical

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, South San Francisco, 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 each role and responsibility 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.


Reports To:

Senior Director, Drug Safety

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, South San Francisco, 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 of the Position*
  • 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)
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 each role and responsibility 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.


Reports To:

Associate Director, Clinical Data Management

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, South San Francisco, Stamford, CT, and Madrid, Spain.

The Manager, Clinical Data Management 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 Data Management vendors to ensure database development, data review/cleaning, database auditing, database lock, and receipt  of final database deliverables follow standard operating procedures and regulatory agency guidelines. The Lead Data Manager ensures all Clinical Operations activities stay within full compliance of Loxo regulatory and legal policies.

Roles and Responsibilities of the Position*
  • Represents Data Management at study team meetings with responsibility for operational execution of DM activities
  • Executes/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
  • Effectively applies knowledge of applicable internal, external and regulatory requirements/expectations (MHRA, FDA, ICH, GCP, PhRMA, Privacy, etc.) to data collection and DM plans
  • Collaborates and oversees CRO/service providers on assigned studies
  • Executes/manages all data management activities on assigned studies to ensure project timelines are met
  • Continually seeks 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
  • Provides DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables
  • Works 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
  • 6+ years’ clinical data management experience
  • Demonstrated leadership and project management skills
  • Good working knowledge of ICH, FDA, and GCP regulations and guidelines
  • Strong well-rounded technical skills (EDC systems, MS Word, Excel, PowerPoint)
  • Knowledge of industry standards (CDISC, SDTM, ADaM, CDASH)
  • 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 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 both independently and/or 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
Additional Preferred Qualifications
  • 5+ years prior oncology/hematology experience highly desirable
  • 2+ years of Sponsor experience.
  • Recent Phase 3 registration study and submission experience preferred
Physical Demands / Travel

The physical demands of this job are consistent with light office duties. This position will travel occasionally (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 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 each role and responsibility 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.


Reports To:

Director, Diagnostic Development & Medical Affairs

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, South San Francisco, Stamford, CT, and Madrid, Spain.

The Diagnostic Development and Medical Affairs (DxDMA) team supports diagnostic aspects of late phase and on market assets as well as the robust pipeline of oncology therapeutic molecules. This role will provide strategic support for the DxDMA organization along with portfolio-level tracking of biomarker and diagnostic components of preclinical and clinical assets for the purposes of ensuring timely reviews by the Diagnostic Lead Team and building transparency for diagnostic activities across the portfolio. The Manager DxDMA will ensure cross functional communication across development, laboratory and medical affairs within the DxDMA organization.

Roles and Responsibilities of the Position*
  • Build strong partnership with Therapeutic Asset Operational Leaders, Project Managers and diagnostic lead team members to enable transparent communication of asset and diagnostics timelines and deliverables.
  • Track diagnostics development and Companion diagnostic requirements and timelines across geographies; Monitor and communicate regional changes impacting diagnostics development
  • Manage relationships with external vendors/partners as requested by the Director of Biomarker Operations
  • Align with diagnostics leadership to ensure cross-functional coordination across both Loxo Oncology at Lilly and Lilly’s Oncology Business Unit (OBU).
  • Develop process maps to gain efficiency and streamline cross-functional processes
  • Helps create process to monitor and track rational deployment of resources to support Dx needs of both early phase and OBU assets
  • Harmonize and integrate key project management processes and tools across diagnostics and both internal and external functional partners
  • Respond to inquiries in a timely and professional manner
  • Respects and leverages others expertise and work experience in a way that encourages learning, collaboration, innovation and commitment to a common vision
  • Facilitate preparation for working group meetings, including but not limited to, preparation of meeting agendas, meeting minutes and summaries
  • Deliver cross-functional results through people utilizing project management, influence and communication skills rather than direct or positional authority.
  • Drive documentation and communication of key decisions, actions, and key modifications in time, budget, scope, and risk to key stakeholders
  • Ensure that the team, key stakeholders and the broader organization understand key project risks. Drive risk management processes to ensure appropriate plans and actions are in place. 
  • Ensure accurate collection, analysis, and communication of metrics with key stakeholders.
  • Drive and support cross functional efforts for continuous improvement and transformation.
  • Various tracking responsibilities may include but are not limited to: budget (including planned vs. actuals), travel, seminars/education, decisions, publications and POs.
  • Ensure alignment with budget items and communication plan back to teams (LO@LLY and OBU)
  • Serve as a champion for the Loxo Oncology @ Lilly culture
Required Qualifications and Background
  • Minimum of a Bachelor's degree in a science-related health field. 
  • Experience in the pharmaceutical industry and/or drug development (5-7 years preferred)
  • Demonstrated project and portfolio management skills (e.g. management of integration, scope, time, cost, quality and communications). PMP certification preferred.
  • Experience within Oncology, integrated drug development and clinical trial operations a strong preference.
  • Experience working in a heavily matrixed organization
  • Excellent communication and interpersonal skills.  Attention to detail and organizational skills are required.
  • Able to effectively facilitate team meetings and team leadership interactions.
  • Drive effective and efficient team decision-making.
  • Good learning agility and flexibility to adjust quickly and effectively to changing business priorities and needs.  Must be able to manage working with a variety of different teams/organizations with varying styles and complexity and to independently manage workload and adjust priorities as needed.
  • Demonstration of leadership behaviors consistent with level expectations
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 each role and responsibility 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.


Reports To:

Associate Director, Regulatory Affairs

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, South San Francisco, Stamford, CT, and Madrid, Spain.

The Manager, Regulatory Affairs will provide support for one (or more) clinical programs and contribute to the execution of major submissions and responses to regulatory authorities related to IND/NDA submissions or international equivalents, Annual Reports, Clinical Protocols, Investigator’s Brochures, IND amendments for meetings with regulatory authorities as required.   

Roles and Responsibilities of the Position*
  • Responsible for supporting all aspects of regulatory submissions relevant to assigned projects or programs.
  • Assist in the coordination of meeting with health authorities and Contribute to the development of briefing packages for meetings with FDA and other global health authorities.
  • Support the implementation of regulatory strategy for assigned projects and programs for projects in all stages of development (IND through commercial).
  • Ensure 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.
  • Provide review of responses and other documents intended for submission to FDA and other global health authorities as needed.
  • Prepare and compile effective presentations for external and internal audiences as needed.
    • Representing the Regulatory Affairs function on assigned cross-functional project teams and to external partners.
    • Actively participate in regulatory sub-teams and lead meetings on defined topics with a clear objective.
  • Other duties as assigned.
Required Qualifications and Background
  • BS degree required; Advanced degree advantageous.
  • Minimum 3+ years’ regulatory experience within the biotech or pharmaceutical industry within the drug development space.
  • Experience and knowledge in the preparation of regulatory submissions and supportive amendments or supplements required.
  • Previous experience navigating successful submissions (INDs/NDAs) in the Oncology space is a plus.
  • Experience in interpretation and application of regulations, guidelines, policy statements, etc. strongly preferred.
  • Exposure to global regulatory requirements a plus.
  • Ability to work both independently and within project teams, to attain group goals.
  • Demonstrate strong organizational skills, including the ability to prioritize tasks.
  • Excellent oral and written 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 each role and responsibility 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.


Reports To:

Director, Regulatory CDx

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, South San Francisco, Stamford, CT, and Madrid, Spain.

The Manager/Senior, Manager 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 role for diagnostics projects.

He/She will be 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’s programs. This individual must perform with a high degree of independence and will work directly on programs. He/She is established as a 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), etc…), 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 Loxo’s bio specimen 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.
  • Work with CDx Program Management to support the development and maintenance of high level and detailed CDx timelines to assure that the functional timelines are aligned with global program timelines.
  • Bring issues to Manager, Project Team leaders or other individual’s attention when 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. Preferred: M.S., or Ph.D.
  • 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.
  • Knowledge of FDA or international HA guidance documents or guidelines relevant to CDx development/registration. E
  • 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.
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 each role and responsibility 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.


Reports To:

Vice President, Medical

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, South San Francisco, Stamford, CT, and Madrid, Spain.

The Medical Director will lead the direction, planning, execution, and interpretation of clinical trials or research activities of one or more clinical development programs. Participates in and may lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data supporting overall product, scientific and business strategy.

Roles and Responsibilities of the Position*
  • Leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, Loxo customers, markets, business operations, and emerging issues. Oversees project-related education of investigators, study site personnel, and Loxo study staff. Responsibility may extend from early translational development activities to mature product lifecycle management strategies for internal and/or partnered programs.
  • Has overall responsibility for leading clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule.  Along with Clinical Operations, is responsible for ensuring agreed-upon study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events.
  • 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 oversee and/or be the direct manager of the work of Clinical Scientists working on the same or related programs. 
  • Serves as an in-house clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific and medical activities with internal stakeholders as they relate to ongoing projects. 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 or equivalent required. Board Certification in Oncology or Internal Medicine preferred
  • PhD would be an advantage
  • Oncology therapeutic area knowledge required
  • At least 3-5 years of clinical trial experience in the pharmaceutical industry, academia, or equivalent, in a medical director role.
  • Proven experience running a complex clinical research program independently.
  • 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.
  • Extensive knowledge of phase 1-3 clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols.
  • Experience leading global regulatory interactions for preclinical, clinical and pivotal programs.
  • Prior management experience 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
  • Excellent English written and verbal communication skills. Strong document management skills, including proficiency with MS Word, EndNote, PowerPoint and Excel.
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 a remote, home based office/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 each role and responsibility 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.


Reports To:

Senior Principal Scientist, Structural Biology

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, South San Francisco, 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 Molecular Biologist 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 molecular biology support within a structural biology & enzymology setting.
  • Coordinate protein construct design with colleagues from varying disciplines, primarily for expression in baculovirus and E.coli expression systems.
  • 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
  • In the future, this position’s responsibilities may include supervision of scientists and associates.
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.
  • Experience with modern cloning technologies e.g. Gibson Assembly, gBlock utilization, high throughput cloning.
  • Experience with a variety of protein expression systems (E.coli, BV, mammalian, yeast) is desirable.
  • 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 each role and responsibility 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.


Reports To:

Director, Mechanistic Biology- Biophysics

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, South San Francisco, Stamford, CT, and Madrid, Spain.

The Principal Scientist will be responsible for design and execution experiments focused on understanding protein-protein and protein-small molecule interactions utilizing biochemical and biophysical methods and techniques.  The mechanistic biology team will work on multiple drug discovery project teams to provide rapid rigorous mechanistic characterizations to differentiate the activities of small molecule compounds, advance novel drug targeting strategies, develop specialized assays for drug discovery project teams, understand drug resistance, and evaluate new targets.  The mechanistic biology team will work closely with other project team members across disciplines including structural biology, cell biology, in vitro pharmacology, and medicinal chemistry.

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. 
  • Develop and continually advance one’s knowledge base on the molecular pathways being targeted by our discovery, clinical and research programs.
  • Proactively investigate new or different technologies and methods to advance our discovery projects.
  • Mentor biochemists and biophysicists engaged in Loxo Oncology at Lilly discovery projects to think deeply and work creatively while delivering excellent scientific results and insights to the project teams and their colleagues.
Required Qualifications and Background
  • PhD in Biochemistry, Chemistry, Molecular/Cellular Biology or related field with 8+ years hands-on biochemistry or biophysics experience in a biotech/pharma setting OR BS/MS in Biochemistry, Chemistry, Molecular/Cellular Biology or related field with 12+ years hands-on biochemistry or biophysics experience in a biotech/pharma setting.
  • Strong background in enzymology and experimental curve-fitting and statistics.
  • Proven track record in design and development of state-of-the-art biophysical methods including, but not limited to; Surface Plasmon Resonance (SPR), Isothermal Titration calorimetry (ITC), Protein small molecule binding/activity assays, mass spectrometry, and protein/protein interaction analysis. 
  • 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 the targeted oncology field from target identification through human clinical trials.
  • Good and thoughtful listener who values collaboration.
  • 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 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 each role and responsibility 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.


Reports To:

Director, Regulatory, CDx

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, South San Francisco, Stamford, CT, and Madrid, Spain.

The Manager Regulatory, CDx will provide project oversight and regulatory submission support for biomarker and diagnostic technologies for the Loxo Oncology at Lilly pipeline and the Lilly Oncology Business Unit (OBU) programs.

He/She will be supporting Biomarker testing related activities to support NDA/sNDA or BLA/sBLA filing and Companion Diagnostic (CDx) development plans. The successful candidate, in collaboration with both Diagnostic (Dx) and Drug (Rx) development teams, will advise on biomarker related testing such as bridging study strategies and deliverables to meet FDA (CDER and CDRH) expectations for both early and late stage clinical development programs.

In addition, he/she will assist/advise in managing the development, outsourcing, and validation of clinically applicable biomarker assays including testing execution and data analysis for the relevant Rx Regulatory submissions. This function will play a critical role in late stage clinical development to support the Eli Lilly Oncology Business Unit (OBU) programs but will also support the Loxo @ Lilly programs (early stage) as needed. This individual will be supervised and mentored/trained to become a regulatory expert in CDx development and will work directly on project teams as the CDx Regulatory representative.

Roles and Responsibilities of the Position*
  • Serve as primary CDx regulatory contact with project teams on OBU programs.
  • Responsible to help coordinating deliverables for regulatory agencies meetings that may include diagnostic partners and internal Dx and Rx teams.
  • Work with Rx Regulatory and CDx Development colleagues to determine best practices related to biomarker testing towards clinical development & global registration activities.
  • Identify potential impact of relevant Rx and CDx regulations on Rx and CDx development &/or registration activities for OBU programs, respectively.
  • Provide project coordination/oversight towards biomarker testing or CDx regulatory deliverables (e.g. SRD, IDE, CDRH pre-subs, CDER briefing documents for FDA meetings), technical feedback on CDx analytical/clinical or bridging study plans, regulatory support, strategic guidance and advisement on OBU project teams.
  • Help develop regulatory strategies related to Biomarker testing to enable timely Rx regulatory submissions and approvals by regulatory agencies (eg, NDA/sNDA), synchronizing with the Rx development plan.
  • Coordinate and support CDx development leads on interactions with diagnostic partners or testing laboratories to mutually align on regulatory needs and expectations for biomarker testing and Rx study endpoints.
  • Help coordinate interactions with FDA/CDRH and other health authorities (HA).
  • Generate/draft SRD, CDRH pre-subs and sections of CDER briefing documents as needed to support Rx Clinical Strategies.
  • Review and approve key regulatory deliverables generated for biomarker testing (ie, bridging study protocols and reports).
  • Help with clinical biomarker data and clinical samples in collaboration with bio specimen teams.
  • Coordinate Dx 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 biomarker/CDx regulatory needs.
  • Work with CDx Program Management to support the development and maintenance of high level and detailed Biomarker/CDx timelines to assure that the functional timelines are aligned with global program timelines.
  • Bring issues to Manager, Project Team leaders or other individual’s attention when necessary and participate in the resolution of delays or potential delays.
  • 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.
  • Minimum of 2-3 years of related work experience in Biotech/Pharma, Diagnostic or Laboratory (e.g., GCP/GMP, CLIA environments)
  • IVD or CDx development (IHC/ISH, PCR, NGS) or regulatory experience at a diagnostics or pharma company or laboratory (CLIA) a plus.
  • Prior therapeutic or diagnostic study protocol and ICF review experience required.
  • Experience with LEO, SharePoint and Box for document review and approvals.
  • Proficiency with Microsoft Office. Experience with Microsoft Office Project a plus.  
  • Strong understanding/knowledge of Biomarker testing required (PCR, IHC/ISH or NGS)
  • Knowledge of ICH and local regulatory authority regulations regarding drug trials a plus.
  • Familiar with planning and execution of biomarker testing to meet patient eligibility and clinical sample collection requirements.
  • Ability to identify or help identify potential challenges/risks associated with biomarker testing to meet patient eligibility and clinical sample collection requirements.
  • 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. Able to function effectively in a team setting within OBU and Loxo@Lilly.
  • Outstanding interpersonal, communication and negotiation skills.
  • Demonstrated ability to guide/coach teams to timely achievement of objectives.
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 each role and responsibility 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.


Reports To:

Executive Director, Global Regulatory Affairs

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, South San Francisco, Stamford, CT, and Madrid, Spain.

This individual will assist our Regulatory authors with formatting of all Regulatory documents as well as prepare and execute quality control over all Regulatory documents for submission to external vendors. Acting as the liaison between LOXO and external publishing vendors, this individual will maintain the submission tracker as well as be responsible for importing all submissions into Documentum. Act as Regulatory Affairs Documentum specialist in compiling and maintaining computerized files in support of all documentation systems.

Roles and Responsibilities of the Position*
  • Perform overall technical and developmental editing of clinical, regulatory, and development document types, including, but not limited to, protocols, protocol amendments, clinical study reports, Investigator’s Brochures, Investigational Medicinal Product Dossiers, INDs and IND amendments, briefing books, patient narratives, abstracts, and manuscripts.
  • Experience with document organization of Regulatory and CMC documents.
  • Perform full editorial reviews on above mentioned document types, ensuring correct grammar, mechanics, usage, style, template adherence, etc., according to company style guide and accepted standards.
  • Manage timelines/workload of document QC activities.
  • Perform document control quality reviews on controlled documents (e.g., SOPs, policies, forms) and department guidelines.
  • Review documents being logged within the quality document system to verify completeness, legibility, formatting, etc.
  • Assist with document control activities, as assigned, including electronic and paper logging, filing, and archiving of quality system documents; document change management; training documentation management, etc.
  • Assist with document logistics during regulatory inspections (e.g., retrieval, logging, review, notifications).
  • Other duties as assigned.
Required Qualifications and Background
  • BS/BA or higher in a relevant field.
  • At least 5 years of Regulatory Documentation/Publishing experience in an FDA (or equivalent) regulated industry.
  • Experience in quality control and/or quality assurance review of regulatory submissions / aggregate reports within the pharmaceutical/regulated industry is critical, including review of documents in an eCTD system.
  • Demonstrated analytical skills and extremely high attention to detail.
  • Demonstrated strength in oral/written communication and interpersonal skills; team player.
  • Demonstrated organizational skills. Experience with cloud based electronic document management systems (e.g., Veeva Vault, Documentum, NextDocs).
Physical Demands / Travel

The average travel for this position is 10-15% 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

No specific work demands.

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 each role and responsibility 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.


Reports To:

TBD

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, South San Francisco, Stamford, CT, and Madrid, Spain.

The Sample Bank Manager will oversee a small team (examples include Coordinator, Specialist, etc.) that will support Sample Bank management activities across multiple departments and external CROs. The Sample Bank Manager will work closely with Discovery leaders and team members to establish and oversee a newly created internal Sample Bank. This team will be accountable for establishing SOPs and processes related to storage inventory, preparation of samples for testing, and shipping/receipt of supplies/samples/compounds for internal assays.

Roles and Responsibilities of the Position*
  • Prepare samples for testing, manage organized storage of samples, provide samples to scientists for internal assays.
  • Experience with acoustic dispensing and automation.
  • The sample back team will prepare assay ready plates for weekly testing in 384 or 1536 plate formats.
  • 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.
  • Help 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.
  • Assist with obtaining quotes for external assays and the coordination of delivery of samples between lab and external vendors, both US and Globally.
  • Maintain effective oral and written communication to Discovery team members and provide support to ensure timelines, costs and risk assessments are met.
  • Provide additional support to the Discovery Team as requested.
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.
  • Working knowledge and experience with inventory/request database systems for compound and biological sample management is required.
  • 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 written, verbal and interpersonal communication skills are required, with ability to work with/across a range of disciplines including biology, medicinal chemistry and bioassay.
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 each role and responsibility 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.


Reports To:

Director, Mechanistic Biology

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, South San Francisco, Stamford, CT, and Madrid, Spain.

The Scientist, Cell Biology, Bioassay Screening will be responsible for identifying, developing, and performing robust, reproducible cell assays to support drug discovery and development in a team environment. The Scientist, Cell Biology, Bioassay Screening will provide hands-on compound testing to support the small molecule drug discovery oncology pipeline. The scientist fulfilling this position will be responsible for characterizing the effects of small molecule compounds on specific protein targets in cells using multiple cell-based assay formats, examples include HTRF, ELISA, In-Cell Western, Flow cytometry- based cell cycle analysis, Mesoscale, and proliferation.  A strong background in experimental curve-fitting, statistics, and assay optimization and execution is required.

Roles and Responsibilities of the Position*
  • Cell Culture Expertise
  • Develop robust cell-based assays
  • Design, execute, and trouble-shoot experiments
  • Experience in the following assay formats: HTRF, ELISA, In-Cell Western, Flow cytometry, Mesoscale, and Chemiluminescence 
  • CRISPR and Cloning experience is a plus
  • Perform comprehensive data analysis
  • Communicate experimental findings to team members
  • Operate, implement and troubleshoot laboratory automation
  • Actively engaged in advancing drug discovery programs 
  • This is a “hands-on” laboratory, based position
Required Qualifications and Background
  • BS/MS in biology, biochemistry or related fields
  • 3+ years of experience culturing cells and performing cell assays
  • A scientific foundation in the understanding and implementation of a wide range of cell-based screening assays and readouts
  • Excellent oral and written communication skills including experimental documentation
  • Works well with team members daily across functional areas
  • Continual learner who works independently and possesses a can-do attitude
  • Ability to multi-task and shift priorities rapidly to meet tight deadlines
  • Highly organized with exceptional attention to detail
  • Proficient in Microsoft Office suite and applications
Additional Preferred Qualifications
  • Experience in biotech or pharma environment
  • A scientific foundation in the understanding and implementation of a wide range of cell-based screening assays and readouts
  • Excellent oral and written communication skills including experimental documentation
  • Works well with team members daily across functional areas
  • Continual learner who works independently and possesses a can-do attitude
  • Ability to multi-task and shift priorities rapidly to meet tight deadlines
  • Highly organized with exceptional attention to detail
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 each role and responsibility 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.


Reports To:

Director, Mechanistic Biology

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, South San Francisco, Stamford, CT, and Madrid, Spain.

The Scientist, Molecular/Cell Biology will be part of the Loxo Oncology at Lilly’s Drug Discovery group in Alexandria Center, NY.  The Drug Discovery group is responsible for identifying molecular targets for life-changing oncology drugs, creating and evaluating novel drug candidates with a focus on small molecule drugs, and providing forward-thinking approaches to advance our clinical portfolio. 

The Scientist, Molecular/Cell Biology will be responsible for creating and evaluating cellular assays, execution strategies to quantitatively determine the potency and selectivity of small molecule compounds and interrogate signaling pathways.  This is a hands-on position for an experienced lab scientist who enjoys working in the lab. This scientist must have excellent people skills and be able to work with a positive, “can-do” attitude in a dynamic, fast-paced, team environment focused on high quality science to deliver innovative cancer drugs.

Roles and Responsibilities of the Position*
  • Create, develop and validate quantitative mammalian cellular assays to address the project team’s mechanistic and functional needs.
  • Establish robust screening assays to support medicinal chemistry lead optimization programs. Establish processes to efficiently and effectively communicate results to the project team. 
  • Design and manage in vivo pre-clinical studies.
  • Identify, evaluate, and manage vendors for outsourced services and studies.
  • Collaborate with colleagues throughout the company to ensure assays meet the program needs and results are appropriately interpreted.
  • 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. 
  • Develop and continually advance one’s knowledge base on the molecular pathways being targeted by our clinical and research programs.
  • 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.
  • In the future, this position’s responsibilities may include supervision of scientists and associates.
Required Qualifications and Background

Required:

  • PhD in Molecular/Cellular Biology, Biochemistry, or related field with 2+ years hands-on molecular biology and cell assay experience in a biotech/pharma setting or BS/MS in Molecular/Cellular Biology or Biochemistry with 5+ hands-on molecular biology and cell assay experience in a biotech/pharma setting.

Ideal candidate will also have:

  • Experience in creating, developing, and running cellular assays; engineering cell lines to express or knock-down genes of interest, interrogating cellular signal transduction pathways, and characterizing kinase activity.
  • Experience with general molecular biological techniques including plasmids engineering, Cloning and mutagenesis, q-PCR, ELISA, MSD and Western Blot etc.
  • Strong background in experimental curve-fitting and statistics.
  • 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 the targeted oncology field from target identification through human clinical trials.
  • Good and thoughtful listener who values collaboration.
  • 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 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 each role and responsibility 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.


Reports To:

Senior Principal Scientist, Structural Biology

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, South San Francisco, 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 Expression 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.
  • Experience with a variety of protein expression systems (E.coli, BV, mammalian, yeast).  Hands-on experience of a variety of insect cell cells (SF9, SF21, T.ni/Hi5) from culture, transfection and characterization is essential.  Utilization of BIICs and TIPS is highly desirable.
  • Experience with small scale analysis of biomass, particularly regarding soluble protein expression.
  • Hands-on experience of protein purification techniques such as IMAC, SEC, IEX are desirable as is experience with the Phynexus and Akta protein purification technology.
  • SDS-PAGE, Western Blot, Cell Counter experience as well as experience of modern cloning techniques such as Gibson Assembly 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 each role and responsibility 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.


Reports To:

Senior Principal Scientist, Structural Biology

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, South San Francisco, 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 each role and responsibility 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.


Reports To:

Translational Biology Group Leader

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, South San Francisco, Stamford, CT, and Madrid, Spain.

With their background in cell and molecular biology or related field, the scientific staff in Translational Biology will support translational research projects associated with Loxo Oncology at Lilly’s preclinical and early development programs. The successful candidate will achieve these objectives through exceptional attention to detail, scientific rigor and collaborations with Loxo’s discovery scientists.

Roles and Responsibilities of the Position*
  • Designing and executing in vitro and in vivo experiments aimed at understanding the mechanisms of action of our lead compounds and characterizing promising biomarkers for predicting clinical response.
  • Developing in vitro and in vivo models to characterize resistance mechanism of our lead clinical compounds.
  • Achieve these objectives through exceptional attention to detail, scientific rigor and collaborations with Loxo’s discovery scientists.
  • Work collaboratively and incorporate diverse perspectives into decision-making.
  • Work successfully in a nimble, fast-paced matrixed environment.
Required Qualifications and Background
  • BA/BS/MS/PhD in cellular and molecular biology or related disciplines with 1+ year of hands-on bench experience, preferably in an industry setting.
Additional Preferred Qualifications
  • Demonstrated expertise using molecular and biochemical assays toward mechanistic understanding of cellular and biological processes.
  • Extensive experience with aseptic mammalian cell culture and familiarity with solid tumor and/or hematologic cell lines is preferred.
  • Highly motivated and independent with strong critical thinking, analytical and excellent record keeping skills.
  • Continual learner and possesses a can-do attitude.
  • Excellent oral and written communication skills.
  • 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.

The ideal candidate will have experience with many of the following:

  • Gene expression in mammalian cells and engineering knock-in & knockdown cell lines using CRISPR, siRNA and/or other technologies.
  • Stable cell line generation
  • DNA and RNA extraction, including from FFPE samples.
  • PCR, qRT-PCR and NGS assays to evaluate DNA mutational status and RNA abundance.
  • IHC, Western blot, ELISA and mass spectrometry assays of protein abundance.
  • Mouse handling and experience with xenograft models is an advantage.
  • Experience with a variety of sample types, such as cancer cell lines, primary cells, organoids, whole blood, and FFPE tissue
  • Organization and coordination of multiple experiments in parallel.
  • Preparing and presenting scientific results internally and externally.
Physical Demands / Travel

It is expected that the successful candidate will spend ~15% of his/her time traveling on behalf of the company.

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

There are no specific work demands. 

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 each role and responsibility 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.


Reports To:

Associate Director, Clinical Scientist

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, South San Francisco, 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 each role and responsibility 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.


Reports To:

Associate Director, Clinical Data Management

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, South San Francisco, Stamford, CT, and Madrid, Spain.

The Senior 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 Data Management vendors to ensure database development, data review/cleaning, database auditing, database lock, and receipt of final database deliverables follow standard operating procedures and regulatory agency guidelines. The Senior Manager ensures all clinical trial operations activities stay within full compliance of Loxo regulatory and legal policies.

Roles and Responsibilities of the Position*
  • Represents Data Management at study team meetings with responsibility for operational execution of DM activities
  • Manages a study or compound team within the DM group
  • Creates and tracks 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
  • Effectively applies knowledge of applicable internal, external and regulatory requirements/expectations (MHRA, FDA, ICH, GCP, PhRMA, Privacy, etc.) to data collection and DM plans
  • Collaborates and oversees CRO/service providers on assigned studies
  • Executes/manages all data management activities on assigned studies to ensure project timelines are met
  • Continually seeks 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
  • Provides DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables
  • Works 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. Master’s degree in life sciences, math, computer science or related field preferred
  • Minimum 10 years’ clinical data management experience, of which 3 must be at a sponsor
  • Demonstrated leadership and project management skills
  • Good working knowledge of ICH, FDA, and GCP regulations and guidelines
  • Strong well-rounded technical skills (EDC systems, MS Word, Excel, PowerPoint)
  • Knowledge of industry standards (CDISC, SDTM, ADaM, CDASH)
  • 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 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 both independently and/or 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
Additional Preferred Qualifications
  • 5+ years prior oncology/hematology experience highly desirable
  • 5 + years of sponsor experience preferred
  • Recent Phase 3 registration study and submission experience preferred
  • Direct report experience preferred
Physical Demands / Travel

The physical demands of this job are consistent with light office duties. This position will travel occasionally (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 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 each role and responsibility 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.


Reports To:

Director, Medicinal Chemistry

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, South San Francisco, 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 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 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 each role and responsibility 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.


Reports To:

Associate Director, Medicinal Chemistry

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, South San Francisco, 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 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 each role and responsibility 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.


Reports To:

Senior Principal Scientist, Translational Medicine

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, South San Francisco, Stamford, CT, and Madrid, Spain.

With a strong background in cancer biology, the Senior Scientist, Translational Medicine will support lab-based translational research projects associated with Loxo Oncology at Lilly’s preclinical and early development programs. This entails independently planning and executing experiments aimed at characterizing our lead compounds, including their: (1) efficacy (in vitro and in vivo), (2) mechanism of action, (3) target patient populations, and (4) biomarkers predicting clinical response. The successful candidate will achieve these objectives by developing and executing in vitro assays, collaborating with Loxo Oncology at Lilly’s discovery scientists, and overseeing research at CROs.

Roles and Responsibilities of the Position*
  • Establish robust assays including a variety of cell-based assays (cell lines and primary cells), lentiviral transduction, enzymatic assays, ELISA, MSD, TR-FRET, Western blot, immunoprecipitation, RT-qPCR, and NGS.
  • Engineer knock-in & knockout cell lines with CRISPR and/or other technologies.
  • Execute high throughput siRNA and/or CRISPR screens of cell lines. 
  • Establish heme-oncology assays including immune cell isolation, flow cytometry, colony formation assay, and stromal cell co-culture assay.
  • 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
  • BS/MS or PhD in a biological discipline with at least 8 years of bench experience, preferably with industry experience in small molecule drug discovery programs.
  • Research experience in oncology, preferably with some exposure to heme-oncology and/or immuno-oncology.
  • Extensive experience with culturing adherent and non-adherent mammalian cell lines and primary cells using excellent sterile technique.
  • Experience with modern cloning technologies, generation of CRISPR-engineered cell lines, development of PD biomarker assays.  
  • 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 each role and responsibility 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.


Reports To:

Director, Statistical Programming

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, South San Francisco, 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.
  • Establish monitoring of data transfers for ongoing trials to identify study conduct or data quality issues.
  • Review Data Management Plan, Data Validation Plan and edit check specifications.
  • Interact cross functionally with Statisticians and other members of the clinical team to perform ad hoc analysis and generate outputs according to the requirements.
  • Implement and contribute to statistical analysis plans; provide additional expertise in the analysis of clinical trial as it relates to protocol development, case report form design and data collection. 
  • Recognize inconsistencies and initiate resolution of data problems
  • Act independently to determine methods and procedures on new assignments.
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 each role and responsibility 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.


Reports To:

Senior Principal Scientist, Structural Biology

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, South San Francisco, 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 Senior Structural Biologist will offer structural and mechanistic insights to a multi-disciplinary discovery team by providing high-resolution protein-ligand crystal structures.

Roles and Responsibilities of the Position*
  • Generate protein-small molecule complex x-ray crystal structures with hands-on lab involvement throughout the entire gene to structure process including protein expression, purification, crystallization, and structure determination.
  • Coordinate protein construct design, expression, and purification with the project team to support biochemical and biophysical assays.
  • Rapidly communicate scientific results and insights to the team.
  • Identify, evaluate, and manage vendors for outsourced services and studies.
  • Collaborate with colleagues throughout the company to ensure structural work meets the program needs and results are appropriately interpreted.
  • 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. 
  • Develop and continually advance one’s knowledge base on genetically targeted drugs and structure-based drug design.
  • 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.
  • In the future, this position’s responsibilities may include supervision of scientists and associates.
Required Qualifications and Background
  • PhD in Biochemistry, Chemistry, or related field
  • Ideal candidate will have with 5+ years hands-on gene to structure protein-small molecule crystallography experience in a biotech/pharma setting.
  • Highly skilled in crystallization of protein-small molecule complexes and high-resolution x-ray structure determination
  • Extensive experience in protein construct design, expression, purification, and characterization
  • 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 biophysical and structural biology, such as Cryo-EM, 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 each role and responsibility 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.


Reports To:

Senior Director, Discovery Bioinformatics

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, South San Francisco, 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
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 each role and responsibility 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.


Reports To:

Director, Medical Writing

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, South San Francisco, 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 each role and responsibility 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.


Reports To:

Director, Mechanistic Biology

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, South San Francisco, Stamford, CT, and Madrid, Spain.

The Senior/Principal Scientist, Cell Biology will be part of the Loxo Oncology at Lilly’s Drug Discovery group in Alexandria Center, NYC. The Drug Discovery group is responsible for identifying molecular targets for life-changing oncology drugs, creating and evaluating novel drug candidates with a focus on small molecule drugs, and providing forward-thinking approaches to advance our clinical portfolio.  The Senior/Principal Scientist, Cell Biology will be responsible for creating and evaluating cellular assays, execution strategies to quantitatively determine the potency and selectivity of small molecule compounds and interrogate signaling pathways. The Senior/Principal Scientist, Cell Biology will have a strong understanding of signal transduction pathways and experience in designing experiments to evaluate molecular interactions and pathways. The Senior/Principal Scientist, Cell Biology will be part of the team designing, managing and evaluating in vivo pre-clinical studies. This is a hands-on position for an experienced lab scientist who enjoys working in the lab. This scientist must have excellent people skills and be able to work with a positive, “can-do” attitude in a dynamic, fast-paced, team environment focused on high quality science to deliver innovative cancer drugs.

Roles and Responsibilities of the Position*
  • Create, develop and validate quantitative mammalian cellular assays to address the project team’s mechanistic and functional needs.
  • Establish robust screening assays to support medicinal chemistry lead optimization programs. Establish processes to efficiently and effectively communicate results to the project team. 
  • Design and manage in vivo pre-clinical studies.
  • Identify, evaluate, and manage vendors for outsourced services and studies.
  • Collaborate with colleagues throughout the company to ensure assays meet the program needs and results are appropriately interpreted.
  • 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. 
  • Develop and continually advance one’s knowledge base on the molecular pathways being targeted by our clinical and research programs.
  • 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
  • In the future, this position’s responsibilities may include supervision of scientists and associates.
Required Qualifications and Background

Required:

  • PhD in Molecular/Cellular Biology or Biochemistry, or related field with either:
    • 6+ years hands-on cell biology experience AND 2+ years work experience in a biotech/pharma setting or
    • 10+ years hands-on cell biology experience
  • OR a BS/MS in Molecular/Cellular Biology or Biochemistry with either

    • 10+ hands-on cell biology experience AND 4+ years work experience in a biotech/pharma setting or
    • 15+ years hands-on cell biology experience

Ideal candidate will also have:

  • Extensive experience in creating, developing, and running cellular assays; engineering cell lines to express or knock-down genes of interest, interrogating cellular signal transduction pathways, and characterizing kinase activity.
  • Experience with flow cytometry and general molecular biological techniques including q-PCR, ELISA, assays for protein-protein interactions and Western Blot etc.
  • Strong background in experimental curve-fitting and statistics.
  • Experience in designing and handling in vivo animal studies.
  • Experience in building up models (cell line, organoid or PDX) from patient samples and using them to test drug activities.
  • 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 the targeted oncology field from target identification through human clinical trials.
  • Good and thoughtful listener who values collaboration.
  • 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 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 each role and responsibility 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.


Reports To:

Senior Principal Scientist, Structural Biology

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, South San Francisco, 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 Structural Biologist will offer structural and mechanistic insights to a multi-disciplinary discovery team by delivering high quality protein, protein: small molecule complex crystals, and protein-ligand crystal structures.

Roles and Responsibilities of the Position*
  • Generate protein-small molecule complex x-ray crystal structures with hands-on lab involvement throughout the gene to structure process including protein expression, purification, crystallization, and structure determination.
  • Coordinate protein construct design, expression, and purification with the project team to support biochemical and biophysical assays.
  • Rapidly communicate scientific results and insights to the team.
  • Collaborate with colleagues throughout the company to ensure structural work meets the program needs and results are appropriately interpreted.
  • 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. 
  • Develop and continually advance one’s knowledge base on genetically targeted drugs and structure-based drug design.
  • 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
  • In the future, this position’s responsibilities may include supervision of scientists and associates.
Required Qualifications and Background
  • BA/BS, MS in Biochemistry, Chemistry, or related field
  • Ideal candidate will have with 2-5+ years hands-on gene to structure protein-small molecule crystallography experience in a biotech/pharma setting.
  • Highly skilled in crystallization of protein-small molecule complexes.
  • Extensive experience in protein construct design, expression, purification, and characterization.
  • 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 biophysical and structural biology, such as Cryo-EM, 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 each role and responsibility 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.


Reports To:

TBD

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, South San Francisco, 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 each role and responsibility 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.


Reports To:

Vice President, Discovery and Applied Genomics

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, South San Francisco, Stamford, CT, and Madrid, Spain.

The Translational Biology Group Leader will be responsible for leading a research team focused on in-depth studies to provide clinically-focused research to guide discovery projects, biomarker strategies, and early clinical development. The translational biology team will work on multiple drug discovery projects and early clinical programs across solid tumors and hematological malignancies providing mechanism-based studies to characterize prototype, literature, and clinical compounds in clinically relevant in vitro and in vivo assays. In addition, the translational biology team will develop and characterize drug resistance mechanisms in in vitro and in vivo models, identify and test drug combinations based on molecular mechanism, and analyze clinical trial patient molecular characterization results to inform discovery, clinical, and diagnostic programs. The translational biology team will work closely with other project team members across disciplines including cell biology, in vivo pharmacology, medicinal chemistry, biochemistry, bioinformatics, and clinical leads.

Roles and Responsibilities of the Position*
  • 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.
  • Actively participate in their team’s research activities (i.e. experimental work, experimental design, advanced analysis, etc.)
  • Effectively communicate biomarker strategies and assays to clinical teams, while also ensuring that insights from the clinical studies   inform discovery projects.
  • Supervise and mentor cell biologists and biochemists engaged in Loxo Oncology at Lilly translational research projects to think deeply and work creatively while delivering excellent scientific results and insights to the project teams and their colleagues.
  • Develop and continually advance one’s knowledge base on the molecular pathways being targeted by our discovery, clinical and research programs.
  • Proactively investigate new or different technologies and methods to advance our discovery projects
Required Qualifications and Background
  • PhD in Molecular/Cellular Biology, Biochemistry, or related field with 8+ years hands-on cell biology experience in a biotech/pharma setting OR BS/MS in Molecular/Cellular Biology, Biochemistry, or related field with 12+ years hands-on cell biology experience in a biotech/pharma setting
  • 2+ years of experience working on hematological malignancies
Additional Preferred Qualifications
  • Demonstrated experience supervising 2 or more scientists.
  • Expertise in designing and commissioning in vivo efficacy studies using cancer cell line and patient-derived xenograft models, to test oncology compounds
  • Strong background in cancer cellular signaling pathway experimentation and experimental curve-fitting and statistics
  • Thorough understanding of engineering knock-in and knockdown cell lines with CRISPR and/or other technologies
  • Experience with early clinical trial studies and the development and implementation of pharmacodynamic and patient selection biomarker assays
  • 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 the targeted oncology field from target identification through human clinical trials
  • Good and thoughtful listener who values collaboration
  • 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 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 each role and responsibility 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.


Position

Outstanding Team Member

Location

Stamford, CT, South San Francisco, CA, or Boulder, CO (or another location to be determined)

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.