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, Regulatory Affairs

Location: South San Francisco, CA

Reports To:

Associate Director, Regulatory Affairs

Position Summary

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

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

Roles and Responsibilities of the Position*

  • Responsible for supporting all aspects of regulatory submissions relevant to assigned projects or programs.
  • Assist in the coordination of meeting with health authorities and Contribute to the development of briefing packages for meetings with FDA and other global health authorities.
  • Support the implementation of regulatory strategy for assigned projects and programs for projects in all stages of development (IND through commercial).
  • Ensure completion of documents and other assigned tasks within established timelines and with high quality – in terms of scientific content, organization, clarity, accuracy, format, consistency and adherence to regulatory guidelines, styles and processes.
  • Provide review of responses and other documents intended for submission to FDA and other global health authorities as needed.
  • Prepare and compile effective presentations for external and internal audiences as needed.
    • Representing the Regulatory Affairs function on assigned cross-functional project teams and to external partners.
    • Actively participate in regulatory sub-teams and lead meetings on defined topics with a clear objective.
  • Other duties as assigned.

Required Qualifications and Background

  • BS degree required; Advanced degree advantageous.
  • Minimum 3+ years’ regulatory experience within the biotech or pharmaceutical industry within the drug development space.
  • Experience and knowledge in the preparation of regulatory submissions and supportive amendments or supplements required.
  • Previous experience navigating successful submissions (INDs/NDAs) in the Oncology space is a plus.
  • Experience in interpretation and application of regulations, guidelines, policy statements, etc. strongly preferred.
  • Exposure to global regulatory requirements a plus.
  • Ability to work both independently and within project teams, to attain group goals.
  • Demonstrate strong organizational skills, including the ability to prioritize tasks.
  • Excellent oral and written communication skills.

Physical Demands / Travel

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

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

Work Environment

This position’s work environment is in an office.

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

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

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