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, Drug Safety

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

Reports To:

Executive Director, Safety 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 Associate Director, Drug Safety is responsible for pharmacovigilance activities involving the Company's products and/or clinical trials. The Associate Director, Drug Safety will manage individual adverse events (AE) cases, including review, processing and evaluation of safety reports. Additional duties include participating in the safety surveillance program for investigational products and assisting with the responsibility of managing technical functions at a cross functional level.

Roles and Responsibilities of the Position*

  • Oversee the proper and timely collection and reporting of AE information from all sources.
  • Assist in the preparation and management of aggregate safety reports (e.g. IND safety reports, DSURs, PSLLs etc.).
  • Perform medical review of AEs/SAEs from clinical trials, interfacing with reporters as needed.
  • Provide support for safety sections of clinical documents, including the review and approval of the safety portion of protocols, ICFs, CSRs, IBs and other documents as needed.
  • Review of protocols, case report forms, guidelines, CSRs and manuscripts as requested.
  • Assist with the development and maintenance of pharmacovigilance related SOPs, policies and work instructions.
  • Create and track case processing metrics for internal monthly safety reports.
  • Contribute to regulatory authority submissions by reviewing safety data and assisting in the preparation of relevant sections.
  • Participate in regulatory and inspections/audits as it relates to pharmacovigilance activities.
  • Collaborate cross functionally with other departments including clinical, biostatistics, data management, clinical operations and regulatory affairs with respect to safety related issues.
  • Liaise to provide drug safety oversight of processes overseen by vendors.
  • Participate in addressing drug safety-related questions from Regulators or to support Company internally.
  • Other duties may be assigned.

Required Qualifications and Background

  • Health science degree: Nursing (RN, BSN, MSN or NP),  RPH, PharmD, PA or MD.
  • Minimum of 7 years of experience in the pharmaceutical industry or CRO, with 5 years in drug safety, pharmacovigilance and risk assessment or relevant experience.
  • Experience in the management of safety information originating from clinical trials and post-marketing sources.
  • Experience in Hematology/Oncology desired.
  • Experience and working knowledge of Good Pharmacovigilance Practices (GPvP) required.
  • Knowledge of U.S. and International Regulatory Reporting Requirements for Product Safety, and of the clinical development process.
  • Working knowledge of relevant regulations and guidance documents governing both safety reporting and processing for both clinical trial and post-marketing environments.
  • Ability to interpret scientific and clinical trial data.
  • Strong verbal and written communications and presentation skills.
  • Proven problem solving, decision-making and interpersonal skills.
  • Detailed knowledge of drug safety databases.
  • Expertise working with MedDRA.
  • Possess strong leadership skills and the ability to compile and disseminate information to others in a cohesive fashion to assure a clear understanding of project status and direction.
  • Proficiency in MS Office Suite.
  • Strong ability to prioritize tasks and keen attention to detail.
  • Ability to be both enterprising and resourceful.
  • Proven ability to work on multiple projects in a fast-paced environment.

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.