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.

Regulatory Affairs Manager, CDx, OBU programs

Location: Indianapolis, IN

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.