Manager, Medical Affairs

Gilead Sciences•Foster City, CA
•$146,540 - $189,640•Onsite

About The Position

Gilead Sciences is seeking a Manager to join its Phase 4 HIV Prevention Medical Affairs Research team. The role supports evidence-generation priorities for LEN PrEP by coordinating proposal reviews and helping manage the portfolio of Gilead-sponsored, collaborative, and investigator-initiated Phase 4 research in HIV prevention. The position is based at Gilead’s Foster City, California location and works with internal and external stakeholders in a fast-paced, cross-functional environment. The Manager supports the HIV Prevention Research Committee process and Phase 4 portfolio, ensuring research processes and study execution align with Medical Affairs research policy and governance, integrated evidence plan priorities, and program strategy. The role also manages projects through completion and contributes to process improvements. People Leader responsibilities include fostering inclusion, developing talent, and empowering teams.

Requirements

  • At least 6 years of experience with a BS/BA, or at least 4 years with an MS/MA.
  • Knowledge of regulatory and legal (Business Conduct) requirements for clinical trials and other Medical Affairs activities, including FDA regulations, ICH guidelines, and GCPs governing clinical trials.
  • Demonstrated project management and organizational skills, including process improvement and managing multiple resources and priority projects with tight timelines while maintaining attention to detail.
  • Ability to work in a global environment, including participating in meetings outside standard work hours to accommodate time zones.
  • Collaborative, team-oriented approach and ability to interact appropriately within Medical Affairs, across Development and senior management, and with external customers and vendors.
  • Excellent interpersonal, written, and verbal communication skills.
  • Track record of executing clearly defined goals and objectives in a fast-paced environment.
  • Ability to work independently with a positive attitude and as part of teams.
  • Ability to engage and manage multiple stakeholders to achieve objectives.
  • Understanding of or experience in Medical Affairs or the pharmaceutical industry in Phase 4 or externally sponsored research programs, or Clinical Development.
  • Scientific knowledge or experience in HIV.

Nice To Haves

  • Professional degree such as a PhD or PharmD.
  • Master’s degree such as an MS or MPH with at least 4 years of experience in clinical or observational research, including research operations.
  • Bachelor’s degree with at least 6 years of experience.
  • Previous experience in Phase 4 research and/or clinical operations.
  • Knowledge of HIV prevention.

Responsibilities

  • Manage review of investigator-initiated, collaborative, and Gilead-sponsored HIV prevention research proposals through the Research Committee review process.
  • Coordinate proposal review meetings with Research Committee Team Leads and Chairs.
  • Support the creation and management of requests for proposals.
  • Support external investigators, scientific leads, Medical Scientists, and other stakeholders in developing and submitting rigorous research proposals to Gilead.
  • Support management of the HIV Prevention Phase 4 portfolio, including liaison with Clinical Operations, local affiliates, and external investigators.
  • Review abstracts and/or manuscripts resulting from the Phase 4 program, as needed.
  • Contribute to ensuring research processes and study execution align with Medical Affairs research policy and governance, integrated evidence plan priorities, and overall program strategy.
  • Work with the Senior Manager to track and monitor contracted studies, intervene with external investigators to support timely execution, and support study closure when contracted milestones are not met.
  • Act as a resource for Research Committee Chairs, voting and standing members, proposal champions, and reviewers.
  • Contribute to process improvements for research proposal and study management systems.
  • Manage projects to completion, anticipate and resolve obstacles collaboratively, and participate in project management activities as assigned by the Research Committee Team Lead and/or Senior Manager.
  • Create inclusion, develop talent, and empower teams through people-management practices.

Benefits

  • Company-sponsored medical, dental, vision, and life insurance plans.
  • Paid time off.
  • May be eligible for a discretionary annual bonus.
  • May be eligible for discretionary stock-based long-term incentives, depending on role.
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