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:

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 Hematologic cancer diagnostic tests in pathology
  • Experience with both anatomic and molecular pathology laboratories and test methods
  • Experience and knowledge of IVD and CDx market, regulatory processes and reimbursement
  • Prior direct management experience
  • Experience interacting with pathologists and pathology laboratories
Physical Demands / Travel

The physical demands of this job are consistent with light office duties. This role requires up to 40% travel primarily to US offices but also with global travel for international business meetings several times per year.

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

Work Environment

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

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

*To perform this job successfully, an individual must be able to perform 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.

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


Reports To:

Director, Toxicology

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 is seeking a Scientific Communications - Associate Manager. The successful candidate for this position can work remotely or be based at one of our discovery research facilities in Boulder, CO, Indianapolis, IN, San Diego, CA or South San Francisco, CA. This position provides support for the preparation and editing of: internal publications and presentations, external publications and presentations and regulatory submission-supporting documents and the associated summaries covering nonclinical pharmacokinetics, safety pharmacology, and toxicology studies of novel oncology treatments. We are looking for someone who can independently draft and manage reviews of such documents/publications. This includes reviewing, editing and organizing scientific study reports and associated documentation in support of regulatory submission. This also includes the preparation of PowerPoint presentations summarizing key experiments using tables, figures and graphs.

Roles and Responsibilities of the Position*
  • Collaborate closely with the scientific Subject Matter Experts (SMEs) to prepare the first draft of assigned documents
  • Develop and maintain document templates for standardized document styles
  • Provide editorial support; this includes ensuring quality of all scientific content, with a focus on clarity, accuracy, and consistency while maintaining adherence to the original scientific content, proper format and regulatory requirements
  • Work with CROs as needed to deliver high quality reports for inclusion in regulatory filings
  • Initiate and manage multiple rounds of document review and ensuing revisions by proactively interacting with all levels of reviewers from SME to Quality Assurance to senior management
  • Effectively manage multiple overlapping projects at different stages and on separate development programs while ensuring timely completion and high quality of assigned documents

This role may be for you if:

  • You can critically analyze and communicate complex scientific information across a range of nonclinical pharmacology and drug metabolism areas including in vivo pharmacokinetics, toxicokinetics, efficacy, safety pharmacology,  toxicology, metabolism and in vitro ADMEstudies
  • You pay strong attention to detail while completing multiple projects and documents at once
  • You have excellent communication and interpersonal skills, verbal and written
  • You can work independently and take initiative to complete tasks in a deadline-oriented environment
Required Qualifications and Background

Education and year of experiences consisting of 1 of the following:

  • BS/MS with 4+ years of post-graduate experience in a non-research setting working in the role of a technical, medical or regulatory writer within the CRO/Pharma/Biotech industry, OR
  • PhD with 1+ years of post-graduate experience in a non-research setting working in the role of a technical, medical or regulatory writer within the CRO/Pharma/Biotech industry
Additional Preferred Qualifications
  • Must be proficient in preparing accurate, written reports
  • Fluent in English
Physical Demands / Travel

The physical demands for the job are consistent with light office duties. This job requires travel less than 10% of the time.

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.

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


Reports To:

Chief of Staff/VP, Program & Alliance 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.

Loxo Oncology at Lilly (LO@LLY) is seeking a Project Manager to provide strategic and operational drug development leadership across the Research and Development portfolio, integrating drug development across all functions and translating strategy into execution to deliver medicines to patients.

Roles and Responsibilities of the Position*

Responsible for Facilitating and Supporting Asset Strategy and Portfolio    Delivery including the following:

  • Manage scope and support creation of a global integrated development plan that articulates the strategy for the molecule and provides the foundation for operational objectives
  • Create and execute project plans and delivery of project milestones.
  • Develop and implement team communication plans and drive communication of key decisions/results to stakeholders.
  • Drive development of a global integrated project budget that ensures alignment with functional representatives and leadership.
  • Proficient in self-management and organizational skills; able to manage workload, set personal and team priorities and adjust as needed.
  • Strong interpersonal and teambuilding skills; able to develop effective teamwork between team members with diverse styles.
  • Project Management Tools/IT Management:
    • Provide quality and timely content using project management tools
    • Monitor and prioritize team risks to suggest ways to avoid/mitigate risks and initiate contingency plans as needed
  • Bring forward areas for continual process improvement to decrease drug development cycle times and cost.
  • Liaise with Project Management Office (PMO) and Resource Modeling and Forecasting (RMF) teams to identify, share, and incorporate best practices into future processes, tools and training.
Required Qualifications and Background
  • Bachelor’s degree preferably in a health-related, scientific or engineering field.
  • Advanced degree or certifications (e.g. MS., MBA, Master’s degree in Project Management or PMP) preferred.
  • Minimum of 3 years of work experience in the pharmaceutical industry, drug development, and/or project management.
  • Knowledge of or previous experience with drug development processes and application of project management tools and processes in cross-functional settings.
  • Proficiency with Microsoft Word, Excel, PowerPoint, Project and capable of maintaining appropriate project documentation.
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.

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


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.

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


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.

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


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.

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


Reports To:

Associate Director or Senior Manager, 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 Data Management Support position is responsible for performing clinical data management tasks from study start-up through eTMF archiving as directed by the study Lead Data Manager (LDM). This individual collaborates with the cross-functional study team to develop Sponsor clinical data review listings,  perform Sponsor Data Manager data review/cleaning, post and QC data transfers to and from Loxo, generate and report on study data metrics, and draft the Sponsor Data Management Plans for LDM review. The Data Management Support position ensures all actions are in full compliance with Loxo standard operating procedures (SOP) and regulatory agency guidelines. 

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

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

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

Work Environment

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

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

*To perform this job successfully, an individual must be able to perform 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.

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


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.

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


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.

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


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.

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


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.

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


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.

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


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.

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


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.

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


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.

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


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.

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


Reports To:

Senior Director, Discovery 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 Discovery Biology Group Leader will be responsible for leading a research team identifying the next generation of molecular targets for cancer therapeutics. The Discovery Biology Group Leader will lead the discovery and early validation of oncology targets through close collaborations with other discovery and translational functions. Experience in molecular biology, cell engineering, and biochemistry through in vitro and in vivo model systems is required. In addition, candidates should be familiar with computational and data-driven tools mining large-scale datasets. The Discovery Biology team will be part of a multi-disciplinary effort focused on high-quality, truth-seeking science to bring forward innovative cancer drug therapy.

Roles and Responsibilities of the Position*
  • Lead cross-functional teams that will be responsible for novel target discovery and validation
  • Supervise and mentor cell biologists and biochemists engaged in target identification and validation to think deeply and work creatively while delivering excellent scientific results and insights to the project teams and their colleagues
  • Develop and continually advance internal drug development efforts through our discovery, clinical and research programs
  • Proactively investigate new or different technologies and methods to advance our discovery projects
  • Collaborate closely with leaders across Loxo Oncology at Lilly to identify, validate and advance new targets into portfolio
Required Qualifications and Background
  • PhD in Molecular/Cellular Biology, Biochemistry, or related field
  • Minimum of 5-8 years postdoctoral and/or research experience with prior experience in target discovery/validation and cancer biology in the biotech or pharma setting
  • Deep experience in areas of cancer biology, molecular biology, biochemistry, and cancer genomics
  • Outstanding communication, writing, and presentation skills is a must
Additional Preferred Qualifications
  • Demonstrated experience supervising scientists
  • Expertise in designing and commissioning studies using cancer cell line and patient-derived xenograft models, to test oncology compounds
  • Experience with cell engineering such as knock-in and knockdown cell lines with CRISPR and/or other technologies
  • Experience working with external CROs (for PDX models, target screening, etc.)
  • Experience with early clinical trial studies and the development and implementation of pharmacodynamic and patient selection biomarker assays
  • Highly organized with excellent analytical, documentation and multi-tasking skills
  • Provide strategic input to target identification and validation strategy to leadership team
  • Ability to collaborate, lead, and influence others
Physical Demands / Travel

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

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

Work Environment

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

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

*To perform this job successfully, an individual must be able to perform 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.

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


Reports To:

Associate Director/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 Lead Clinical Data Manager is responsible for leading and overseeing data management tasks from study start-up through database lock for clinical trials.  This individual works collaboratively across multiple cross functional groups including Clinical Trial Managers (CTM’s), Biostatistics and Clinical Data Management vendors to ensure database development, data review/cleaning, database auditing, database lock, and receipt of final database deliverables are in compliance with standard operating procedures and regulatory agency guidelines. The Lead Clinical Data Manager ensures all Clinical Operations activities stay within full compliance of Loxo standard operating procedures (SOP) and regulatory agency guidelines.

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

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

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

Work Environment

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

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

*To perform this job successfully, an individual must be able to perform 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.

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


Reports To:

Associate Director, Program Management, Large Molecule Discovery Biologics

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

The role will be responsible for understanding strategic goals and facilitating the planning and execution of deliverables within scope, budget, and timeline in a cross-functional, dynamic environment. The role will work closely with team members across Loxo Oncology Large Molecule group to assess needs for outsourcing as well as actively engaging in identifying, establishing and managing external collaborators and vendors to meet any outsourcing needs.

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

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

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

Work Environment

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

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

*To perform this job successfully, an individual must be able to perform 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.

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


Reports To:

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

Loxo Oncology at Lilly is looking for an independent self-starter to assist with method development, method transfers, and method qualifications/validations of IND stage molecules into phase I/II clinical trials. This individual will be responsible for troubleshooting drug substance and drug product analytical issues that arise during development, the preparation of technical reports, and authoring/reviewing drug product and drug substance sections of CMC regulatory submissions.

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

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

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

Work Environment

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

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

*To perform this job successfully, an individual must be able to perform 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.

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


Reports To:

Director, Facilities & EHS

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 Facilities Manager will oversee and coordinate all site-related activities for Loxo Oncology at Lilly personnel in their designated site. The Manager, Facilities will identify and manage external vendors to ensure safe and efficient laboratory and office spaces for Loxo scientists on site. Working cross functionally, the Facilities Manager will excel at relationship building at all levels of the organization and thrive in a fast-paced environment. The Manager, Facilities will work closely with the Loxo Facilities and IT department teams to set strategy, develop long-term planning, oversee construction and successfully execute projects. The goal is to ensure Loxo’s business accommodation is problem-free and safe so that employees can work under the best conditions.

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

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

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

Work Environment

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

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

*To perform this job successfully, an individual must be able to perform 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.

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


Reports To:

Pharmacology Project 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.

The Pharmacology Principal Scientist will be responsible for identifying, developing, and performing robust, reproducible in vitro and in vivo assays to support tier 1-3 assays.  The Scientist will provide hands-on compound testing to support the small molecule drug discovery oncology pipeline and will be responsible for characterizing the effects of small molecule compounds on specific protein targets using multiple assay formats. A strong background in experimental curve-fitting, statistics, and assay optimization and execution is required.

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

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

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

Work Environment

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

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

*To perform this job successfully, an individual must be able to perform 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.

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


Reports To:

Pharmacology Project 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.

The Pharmacology Scientist will be responsible for identifying, developing, and performing robust, reproducible in vitro and in vivo assays to support tier 1-3 assays.  The Scientist will provide hands-on compound testing to support the small molecule drug discovery oncology pipeline and will be responsible for characterizing the effects of small molecule compounds on specific protein targets using multiple assay formats. A strong background in experimental curve-fitting, statistics, and assay optimization and execution is required.

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

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

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

Work Environment

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

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

*To perform this job successfully, an individual must be able to perform 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.

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


Reports To:

Director, Toxicology

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 Toxicologist will be responsible for the planning, execution, and monitoring of DMPK and toxicology studies for advancing candidates through early target assay development, lead optimization, candidate selection and into IND-enabling studies and beyond.

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

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

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

Work Environment

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

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

*To perform this job successfully, an individual must be able to perform 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.

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


Reports To:

Associate Director, Large Molecule Discovery R&D

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 Project Manager will play a prominent role in managing projects within the Large Molecule Oncology Discovery R&D program portfolio with a focus on research, preclinical, and early development. The role will be responsible for understanding project goals and facilitating the planning and execution of deliverables within scope, budget, and timeline in a cross-functional, dynamic environment. The role will work closely with team members across Loxo Oncology Large Molecule group to assess any needs for outsourcing and actively engage in identifying, evaluating, engaging and managing external collaborators and vendors to meet outsourcing needs.

Roles and Responsibilities of the Position*
  • Coordinate with functional leads of translational, mechanistic biology, antibody, and protein engineering (and other key stakeholders) to plan, execute, track, and deliver project tasks and activities meeting project deliverables within scope, timeline, and budget.
  • Facilitate project meetings with internal and external stakeholders (if applicable) including establishing agendas, drafting minutes and tracking action items ensuring project deliverables are met.
  • Facilitate the drafting of project updates and reports, PowerPoint slide presentations, memos as needed for projects and maintain project document repository.
  • Support the creation of an organizational project management framework to be utilized across different functional groups including the build out of new process(es).
  • Actively engage in meeting project outsourcing needs by coordinating with team members to identify, assess, establish, and manage activities involving external collaborators and vendors.
  • Facilitate in managing day-to-day operational activities by coordinating with different functional teams, legal, procurement, finance, and other internal and external stakeholders.
  • Assist in building and operationalizing large molecule discovery labs.
  • Proactively navigate changes occurring in priorities and adapt to drive project outcomes ensuring re-alignment with program deliverables in changing landscape.
  • Proficient in adaptive communications. Able to effectively communicate and navigate through technical and non-technical audiences across cross-functional departments within the company and external collaborators.
  • Contribute to building positive, collaborative teams across various scientific disciplines and encouraging sharing of new ideas, and creative ways to solve problems often needed in discovery research.
Required Qualifications and Background
  • BS degree in relevant scientific fields (e.g., Biology) required; advanced degree preferred. PMP certification is desirable, not required.
  • 3-5+ years project management experience in within Biotech and pharmaceutical research within early phase large molecule discovery set up.
  • Experience in managing projects in early stage large molecule discovery in large molecule discovery operations.
  • Understand differences between high-level program goals and day-today operations.
  • Experience in managing external suppliers, vendors, and other external alliances.
  • Excellent verbal, written communication and interpersonal skills.
  • Excellent organizational skills, efficient, with strong attention to detail.
  • Ability to anticipate key challenges and proactively propose solutions.
  • Adaptive to changes and apply creative problem-solving skill to meet project and other operational needs.
  • Proficient in identifying and applying tools to effectively manage and track projects - MS Office suite, MS Project.
  • Create and implement new tools and work towards creating and implementing processes customized for furthering discovery research.
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.

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


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.

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


Reports To:

Scientist, 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.

This position is an opportunity to learn and grow within a dynamic mechanistic biology team dedicated to creating specific targeted therapeutics for genetically defined oncology targets.  The ideal candidate is someone who enjoys technical challenges and is not afraid to get their hands dirty by helping with core lab functions including cell culture, protein characterization, biophysical experiments, and laboratory automation. The qualified candidate will have experience with basic chemistry/biology laboratory practices and is passionate to learn additional techniques working in a growing dynamic group focused on discovery research. The successful candidate will work as part of a collaborative team of scientists with expertise in protein production, cell culture, chemistry, biochemistry, structure, and biophysics, supporting hit-to-lead and lead-ID phases of our oncology drug programs. The candidate will have opportunities to learn cutting edge techniques and to learn and develop technical expertise in protein biochemical and biophysical characterization.

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.
  • Maintain and characterize various mammalian cell types in vitro.
  • Purification of recombinant proteins 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 or MS in Chemistry, Biology, Biochemistry, or related field.
  • Ideal candidate will have hands-on experience with protein characterization and cell culture.
  • 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.

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


Reports To:

Imaging Leader, Discovery Technologies

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.

As a Scientist in the Discovery Technologies, Imaging group, you will be joining a large and dynamic group focused on executing experiments on the cutting edge of pharmaceutical sciences. You will design and conduct experiments needed to support the various research programs for identified targets. You will be expected to demonstrate expertise with high-quality imaging needed for biological sciences (e.g., confocal, live cell imaging, 3D assays) and well versed in all aspects of image analysis. You will be responsible for maintenance of the imaging facilities and to liaise with instrument manufacturers to ensure Loxo’s imaging facilities remain state-of-the-art. You will also be encouraged to develop your own ideas and contribute these to the broader group. You are expected to be a dynamic and motivated scientist who can drive their own experiments and research activities, while collaborating extensively with the rest of the organization to execute on various research programs.

Roles and Responsibilities of the Position*

Scientific roles and responsibilities

  • Design and execute studies using confocal microscopy and live cell imaging instruments
  • Assay development and cell line engineering to generate fluorescent fusions and novel signaling reporter assays
  • Image cell-cell interactions (i.e., CD3 redirection), cells expressing proteins of interest (i.e., cytokines, tumor associated antigens, organelles etc.), subcellular localization, trafficking, plasma membrane dynamics
  • Image analysis and algorithm development, data management
  • Maintain imaging facility instruments and become point of contact for any and all imaging needs for entire R&D organization
  • Interrogate experimental conduct of third parties/vendors
  • Facilitate experiments with in vivo pharmacology group

Additional responsibilities:

  • Communicate results at project team meetings, be involved in the coordination and preparation of presentations
  • Responsible for writing reports (internal and/or regulatory)
  • Discuss results with technical as well as non-technical personnel
  • Work in cross functional environments via extensive collaboration with other parts of the organization
  • Opportunity to directly manage junior scientists in the future
Required Qualifications and Background
  • BSc. in biological sciences with 5+ years of experience or MSc or PhD in biological sciences with 2-3 years of experience
Additional Preferred Qualifications
  • PhD preferred
  • Extensive expertise in confocal microscopy and live cell imaging, assay development, high content imaging, signaling reporter assays, TIRF and image analysis
  • Experience with super resolution microscopy highly desirable
  • Experience in drug discovery an asset
  • Experience in automation and high throughput screening an asset
  • Deep expertise in translational biology concepts, history of working with organoids and 3D assays, as well as in vivo models (e.g., mice models) considered an asset
  • Expertise in cancer disease states (indications, mutational status, tumor cell drivers)
  • Demonstrated experience in working collaboratively across various scientific disciplines to meet end goals of business
  • Demonstrated ability to succeed in a fast-paced environment, working on multiple projects with constantly changing priorities and deadlines
  • Excellent written, verbal communication and interpersonal skills
Physical Demands / Travel

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

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

Work Environment

You will be working in our state-of-the-art laboratories in our NYC facility.

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.

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


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.

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


Reports To:

Director, Toxicology

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 Toxicologist will be responsible for the planning, execution, and monitoring of DMPK and toxicology studies for advancing candidates through early target assay development, lead optimization, candidate selection and into IND-enabling studies and beyond.

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

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

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

Work Environment

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

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

*To perform this job successfully, an individual must be able to perform 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.

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


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.

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


Reports To:

Executive Director, Medical/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 Senior Medical Monitor will lead and support the expansion of clinical development programs (or one large, complex program) in support of the overall product development plan and serve as an ambassador and resource to various physicians and clinical trial sites, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, Loxo customers, markets, business operations, and emerging issues, and perform other responsibilities as requested.

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

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

This role will require 50-60% travel.

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

Work Environment

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

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

*To perform this job successfully, an individual must be able to perform 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.

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


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 industry setting.
  • Proven track record of success in advancing programs from leads to advanced candidates.
  • Extensive experience in lead compound optimization for potency, selectivity, ADME and PK.  
  • Experienced in the use of synthetic chemistry instrumentation: HPLC, LC-MS, NMR, and purification systems.
  • Expert in using common medicinal chemistry software: electronic notebook, ChemDraw, Excel; data visualization; structure viewing; literature, chemical and database searching.
  • Committed to staying current with the latest scientific breakthroughs in the medicinal chemistry field through continued reading of the literature and attendance of scientific conferences. 
  • An excellent team player with ability to communicate synergistically with a multidisciplinary team and be accountable for the medicinal chemistry progress of the project. Highly organized with excellent analytical, documentation, time management, and multi-tasking skills.
Physical Demands / Travel

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

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

Work Environment

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

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

*To perform this job successfully, an individual must be able to perform 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.

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


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 industry setting.
  • Proven track record of success in advancing programs from leads to advanced candidates.
  • Extensive experience in lead compound optimization for potency, selectivity, ADME and PK.  
  • Experienced in the use of synthetic chemistry instrumentation: HPLC, LC-MS, NMR, and purification systems.
  • Expert in using common medicinal chemistry software: electronic notebook, ChemDraw, Excel; data visualization; structure viewing; literature, chemical and database searching.
  • Committed to staying current with the latest scientific breakthroughs in the medicinal chemistry field through continued reading of the literature and attendance of scientific conferences. 
  • An excellent team player with ability to communicate synergistically with a multidisciplinary team and be accountable for the medicinal chemistry progress of the project. Highly organized with excellent analytical, documentation, time management, and multi-tasking skills.
Physical Demands / Travel

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

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

Work Environment

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

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

*To perform this job successfully, an individual must be able to perform 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.

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


Reports To:

Research Fellow, Large Molecule 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/Principal Scientist will lead a dynamic group of scientists (internal team as well as external CRO) conducting various research projects to identify large molecule/biologics which can effectively treat various forms of cancer.  This is a hands-on role where you will lead from the bench.  The Senior Principal Scientist/Principal Scientist will design and perform experiments that determine the efficacy of pipeline agents through a variety of techniques such as in vitro and ex vivo assays, target validation, and functional screening. Collaboration across functional areas within Loxo Oncology at Lilly is required including Large Molecule and Oncology Biologics senior leadership.  The Senior Principal Scientist/Principal Scientist will be a key member of the large molecule organization, where you will be responsible for maintaining the scientific quality and efficiency of your organization, as well as assist and contribute to the strategic direction of large molecule discovery.

Roles and Responsibilities of the Position*
  • Design and oversee the execution of key mechanistic and discovery biology experiments involving diverse oncogenic mechanisms (i.e., tumor indications, signaling, cancer targets, biologic mechanisms of tumor inhibitions).
  • Maintain focus on project deliverables and prioritize experiments and efforts accordingly.
  • Oversee/perform assays to identify the drug candidate evaluate the candidate for clinical testing.
  • Liaise with CROs and vendors to outsource activities, provide input to management team on vendor selection.
  • Provide scientific expertise when determining organizations to strategically partner with.
  • Interrogate experimental conduct of third parties/vendors.
  • Participate in target identification in collaboration with leadership.
  • Build, lead, and manage team of Scientists at various levels.  
  • Indirectly oversee work of third parties/vendors (e.g., CROs).
  • Manage resource allocation effectively.
  • Build roadmaps to execute on specific targets, and overall strategic projects.
Required Qualifications and Background
  • PhD in cellular biology, immunology, or allied disciplines with minimum 3+ years’ industry experience OR BS/MS with 10+ years of direct pharmaceutical/biotechnology experience.
  • Laboratory experience with ADC and CD3 platforms and biologic assays.
  • Knowledge on immune targets and myeloid biology/targets.
  • Strong attention to detail and highly goal oriented with demonstrated critical thinking capabilities.
  • Ability to trouble shoot effectively and think outside of the box.
  • Ability to collaborate with translational biology functions (PK/PD, toxicology, Ab discovery).
  • Proven success leading, managing, and coaching others (either directly or indirectly).
  • Demonstrated ability and track record in managing work overseen by third parties/vendors/strategic partners.
  • Demonstrated experience in working collaboratively across various scientific disciplines to meet end goals of business.
  • Demonstrated excellence in making key strategic decisions in support of broader business goals.
  • Excellent written and verbal communication skills.
Physical Demands / Travel

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

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

Work Environment

This position’s work environment is in a lab.  

The work environment characteristics described here are representative of those 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.

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


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 strong background in biochemistry and small molecule drug discovery, the Senior Scientist, Translational Medicine will support lab-based research projects associated with Loxo Oncology at Lilly’s preclinical and early development programs. This entails independently planning and executing experiments focused on understanding protein-protein and protein-small molecule interactions utilizing biochemical and biophysical techniques. 

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

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

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

Work Environment

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

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

*To perform this job successfully, an individual must be able to perform 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.

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


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.
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.

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


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.

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


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.

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


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.

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


Reports To:

Group Leader, Discovery 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, Discovery Biology will be part of the Loxo Oncology at Lilly’s Discovery group identifying the next generation of molecular targets for cancer therapeutics.  The Senior/Principal Scientist, Discovery Biology will be responsible for creating and executing strategies toward discovery and early validation of oncology targets through close collaboration with other discovery and translational functions. The Senior/Principal Scientist, Discovery Biology will have a strong understanding of oncogenic pathways and experience in designing experiments to evaluate molecular interactions and pathways. The Senior/Principal Scientist, Discovery Biology will be part of a multi-disciplinary effort focused on high-quality, truth-seeking science to bring forward innovative cancer drug therapy.

Roles and Responsibilities of the Position*
  • Create, develop and validate quantitative mammalian cellular assays to credential novel targets
  • Establish robust high-throughput screening assays
  • Design and manage in vivo pre-clinical studies.
  • Conceive and lead collaborative projects on biomarker-driven programs
  • Evaluate emerging technologies, methods, and service providers to ensure our work is being done in a scientifically sound, efficient, and reasonable way
  • Collaborate with colleagues throughout the company to ensure assays meet the program needs and results are appropriately interpreted.
  • Participate and thrive in an interactive, team-oriented culture
  • Directly manage and mentor lab-based staff
Required Qualifications and Background
  • PhD in Molecular/Cellular Biology or Biochemistry, or related field
  • Minimum of 3-6 years of postdoctoral and/or hand-on research experience, preferability in biotech/pharma setting
  • Experience in relevant areas of cancer and molecular biology
  • Outstanding communication, writing, and presentation skills is a must
Additional Preferred Qualifications
  • Experience with cell engineering such as knock-in and knockdown cell lines with CRISPR and/or other technologies
  • Experience with flow cytometry and general molecular biological techniques including q-PCR, signaling experiments, assays for protein-protein interactions and Western Blot etc.
  • Experience in designing and handling in vivo animal studies
  • Experience in building models (cell line, organoid or PDX) from patient samples and using them to test drug activities
  • Experience working with external CROs
  • Excellent interpersonal skills with ability to communicate and interact well with colleagues, vendors, contractors, scientific advisors, and staff at all levels and problem solving skills
  • Ability to summarize complex experiment and results for non-specialists
  • Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies
Physical Demands / Travel

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

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

Work Environment

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

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

*To perform this job successfully, an individual must be able to perform 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.

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


Reports To:

Chief of Staff/VP, Program & Alliance 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 Technical Operations Specialist will drive a variety of critical projects within LO@LLY, in most part related to broader Lilly integration efforts. In 2021, this role will primarily focus in two areas: 1) Records retention across functional areas (75% of time) and 2) Technical processes related to integration processes (eg Box folder management, team member access and permissions, etc) (25% of time). Additional/Future projects will be identified beginning in the second half of 2021.

Roles and Responsibilities of the Position*
  • Serve as the internal expert on Records Retention – fully familiarize self with Lilly’s Global Record Retention Schedule
  • Work within each functional area at LO@LLY to develop a plan and process for implementation of Lilly’s Record Retention Schedule, including any Legal Holds
  • Ability to work cross functionally between LO@LLY and Lilly to share best practices and implementation strategies.
  • Completes projects by coordinating resources and timetables with department leads and designees
  • Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; completing all necessary training
  • Establishes and maintains strong partnership with IT Systems SMEs
  • Partner with Integration Leader to support and drive delivery of integration initiatives by maintaining delivery timelines, document and manage meeting minute, follow up and track cross functional actions and follow up from meetings
  • Manage integration Box repositories in both content and organizational access for integration work
  • Manage and oversee routine or periodic updates of integration practices, processes and supporting content; drive updating content as necessary with functional owner or SME
  • Proficient in self-management and organizational skills; able to manage workload, set priorities and adjust as needed
  • Strong interpersonal and teambuilding skills; able to develop effective teamwork between team members with diverse styles
  • Monitor and prioritize team risks to suggest ways to avoid/mitigate risks and initiate contingency plans as needed
  • Bring forward areas for continual process improvement
  • Liaise with cross-functional teams to identify, share, and incorporate best practices into future processes, tools and training
Required Qualifications and Background
  • Bachelor’s degree preferably in a health-related, scientific or engineering field.
  • Minimum of 3 years of work experience in the pharmaceutical industry, IT, and/or QA.
  • Working knowledge in pharmaceutical records management, including electronic and hard copy media
  • Experience in implementing complex records management program/schedules across functional areas (legal, finance, clinical, etc.)
  • Strong organizational and communication skills
  • “Self-starter”, who works with minimal supervision
  • Solution oriented and works with a sense of urgency
  • Knowledge of or previous experience with technical/digital tools and/or application of compliance/QA SOPs across functional areas.
  • Proficiency with Microsoft Word, Excel, PowerPoint, Project and capable of maintaining appropriate project documentation.
  • Proficiency with Box structure, appropriate access levels and content management
Physical Demands / Travel

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

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

Work Environment

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

The work environment characteristics described here are representative of those 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.

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


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.

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


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.

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