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.

Associate Director, Medical Writer

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

Reports To:

Head of 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 Associate Director, Medical Writing, will be responsible for the efficient preparation of high-quality, strategically aligned medical writing deliverables that support the clinical development, safety and regulatory requirements of a clinical program. The Associate Director, Medical Writing will work to ensure that strategically aligned communication points are conveyed in medical writing deliverables and that the communication points are consistent across all program documentation. The Associate Director, Medical Writing will oversee the medical writing staff and coordinate and manage all writing resources (internal as well as external).

Roles and Responsibilities of the Position*

  • Drives messaging strategy and documentation timelines across multiple clinical programs to ensure effective communication (i.e., protocols, submissions, briefing books, responses to HA questions) and successful clinical development.
  • Analyze proposed plans, programs, individual studies and related documents for their ability to deliver the information required by the target audience (i.e., regulatory authority) in a compelling fashion with accuracy and consistency.
  • Responsible for aligning, coordinating and building consistent information and messages across all individual documents within a clinical program, starting with initial strategic plans, continuing through study level documents to final program level deliverables (i.e., regulatory submission or publication of key journal articles for a publication plan).
  • Understands issues affecting the design of clinical development strategy, and understands how study design, data capture and statistical analysis plan design will affect downstream documents.
  • Responsible for ensuring that statements included in the deliverables are accurate and supported by appropriate data.
  • Sets program-level standards (e.g., style convention)

Required Qualifications and Background

  • BA/BS or higher and at least 6 years of writing experience in the pharmaceutical industry
  • Exceptional written and oral communication skills and ability to write and edit complex material to ensure accuracy, clarity, and effectiveness
  • A solid understanding of the clinical development process, including the documents that are required at each stage.
  • Expert MS Office skills with a special focus on word processing, tables, spreadsheets, presentations, graphics and templates.
  • Knowledge of ICH and CTD guidelines for clinical and regulatory submission documents
  • Ability to think strategically with demonstrated negotiating skills and resourcefulness.
  • Ability to manage several projects simultaneously.
  • Ability to analyze critically and synthesize complex scientific information from a range of scientific disciplines and clinical therapeutic areas.
  • Successful track record of leading complex clinical / regulatory writing projects.
  • Excellent organizational and time management 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.