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.

Manager/Senior Manager, Regulatory CDx

Location: South San Francisco, CA or Boulder, CO or Stamford, CT or Remote

Reports To:

Director, Regulatory CDx

Position Summary

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

The Manager/Senior, Manager Regulatory, CDx will provide project oversight and regulatory submission support for biomarker and diagnostic technologies for the Loxo Oncology at Lilly pipeline, in addition to supporting program management role for diagnostics projects.

He/She will be supporting Companion Diagnostic (CDx) development plans. The successful candidate, in collaboration with both Diagnostic (Dx) and Drug (Rx) development teams, will advise on the managing the CDx partners and CROs developing diagnostic assays, coordinating transfer of materials and knowledge as well as collaborating with partners towards timely CDx regulatory submissions in a small fast-paced, dynamic work environment. In addition, he/she will assist/advise in managing the development, outsourcing, and validation of clinically applicable biomarker assays. This function will play a critical role in R&D, with emphasis on later stage diagnostic development associated with Loxo’s programs. This individual must perform with a high degree of independence and will work directly on programs. He/She is established as a regulatory expert in CDx development.

Roles and Responsibilities of the Position*
  • Responsible for planning and executing meetings with regulatory agencies that include diagnostic partners and internal Dx and Rx teams.
  • Work with Rx regulatory colleagues and diagnostic partners to determine best practices towards development & global registration activities.
  • Evaluate impact of relevant Rx and CDx regulations on Rx and CDx development & registration activities, respectively.
  • Provide project management/oversight towards CDx regulatory deliverables (e.g. SRD, IDE, CDRH pre-subs, PMA, 510(k), etc…), technical feedback on CDx analytical and clinical study plans, regulatory support, strategic guidance and advisement on CDx project teams.
  • Help develop strategies to enable timely registration and approval of diagnostic products by regulatory agencies, synchronizing with the therapeutic development plan.
  • Provide leadership and support interactions with diagnostic partners to mutually align on co-development regulatory needs and expectations for major project tasks like regulatory pre-market approval (e.g. PMA, 510(k), EU technical files and international registration deliverables) submissions.
  • Support team or lead interactions with FDA/CDRH and other health authorities (HA).
  • Generate SRD and CDRH pre-subs as needed to support Rx Clinical Strategies
  • Review and approve key regulatory submissions to CDRH generated by CDx partners.
  • Help with clinical biomarker data and CDx samples in collaboration with Loxo’s bio specimen team.
  • Generate CDx regulatory team meeting schedules, agendas and meeting minutes.
  • Support Dx teams on contracts, budgets, project and development timelines.
  • Maintain knowledge of applicable CDx regulatory requirements and scientific/technical issues relevant to assigned projects.
  • Work with Rx regulatory team members to align all CDx regulatory project activities and deliverables from each functional area.
  • Work with CDx Program Management to support the development and maintenance of high level and detailed CDx timelines to assure that the functional timelines are aligned with global program timelines.
  • Bring issues to Manager, Project Team leaders or other individual’s attention when necessary and participate in the resolution of delays or potential delays.
  • Manage project team meetings as well as minutes, agendas, action items, etc.
  • Respond to changing duties as responsibilities may vary based on potential pipeline growth, project needs, and stages of development (pre- clinical, clinical or commercial).
Required Qualifications and Background
  • B.S. degree or higher, preferably in a health-related field. Preferred: M.S., or Ph.D.
  • Minimum of 3 years of late stage CDx development and regulatory experience at a diagnostics or pharma company.
  • Prior CDRH pre-submission, SRD, PMA experience required
  • NGS assay development/regulatory experience preferred
  • Familiar with regulatory issues and challenges associated with drug/diagnostic co-development and companion diagnostics.
  • Knowledge of FDA or international HA guidance documents or guidelines relevant to CDx development/registration. E
  • Experience with Japan, China, South Korea CDx registration a plus.
  • Well-developed Regulatory project management execution, communication, and presentation skills.
  • High level of integrity, accuracy, and attention to detail.
  • Self-organized, self-directed, highly motivated with strong critical thinking and analytical skills.
  • Willingness to work collaboratively, think critically, and incorporate diverse perspectives into decision-making.
  • Demonstrated ability to work successfully in a nimble, fast-paced matrixed environment.
  • Outstanding interpersonal, communication and negotiation skills.
  • Demonstrated ability to guide/coach teams to timely achievement of objectives.
Physical Demands / Travel

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

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

Work Environment

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

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

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

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