Manager, Medical Affairs

Gilead Sciences • Foster City, CA

4d • Onsite

About The Position

Gilead Sciences is seeking a Manager to join its Phase 4 HIV Prevention Medical Affairs Research team in Foster City, California. The role supports evidence-generation priorities for LEN PrEP by coordinating proposal reviews and supporting portfolio management for Phase 4 Gilead-sponsored, collaborative, and investigator-initiated research in HIV prevention. The successful candidate will bring experience in Phase 4 research and/or clinical operations, knowledge of HIV prevention, and the ability to work effectively with internal and external stakeholders in a fast-paced, cross-functional environment.

The Manager coordinates proposal reviews through Gilead’s Research Committee (RC) process, supports requests for proposals, and assists investigators and other stakeholders with developing and submitting rigorous research proposals. The role also supports management of the HIV Prevention Phase 4 portfolio, study execution and closure, research governance and policy alignment, and process improvements. The Manager may review abstracts and manuscripts and will manage projects through completion, anticipating and resolving obstacles collaboratively.

As a people leader now or in the future, the role is expected to promote inclusion, develop talent through coaching and development opportunities, and empower teams by connecting team goals to organizational purpose and enabling cross-functional collaboration.

Requirements

• At least 6 years of experience with a BS/BA, or at least 4 years with an MS/MA.
• Knowledge of and adherence to regulatory and legal (Business Conduct) requirements for clinical trials and other Medical Affairs activities.
• Knowledge of FDA regulations, ICH guidelines, and GCPs governing clinical trials.
• Demonstrated project management and organizational skills, including process improvement and management of 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-zone differences.
• Ability to work collaboratively and interact appropriately within Medical Affairs, across Development, with senior management, and with external customers and vendors.
• Excellent interpersonal, written, and verbal communication skills.
• Proven ability to execute clearly defined goals and objectives in a fast-paced environment.
• Ability to work independently with a positive attitude and as part of a team.
• Ability to engage and manage multiple stakeholders to achieve objectives.
• Understanding of or experience in Medical Affairs or the pharmaceutical industry, including 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.

Responsibilities

• Manage reviews 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, liaising with Clinical Operations, local affiliates, external investigators, and other cross-functional partners.
• Review abstracts and/or manuscripts resulting from the Phase 4 program, as needed.
• Help ensure 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 closure of studies that are not meeting contracted milestones.
• Act as a resource for Research Committee Chairs, voting and standing members, proposal champions, and reviewers.
• Contribute to improvements in research proposal and study management processes and systems.
• Manage assigned projects to completion, anticipate and resolve obstacles collaboratively, and perform project management activities as needed by the assigned Research Committee Team Lead and/or Senior Manager.
• As a people leader, create inclusion, develop talent, and empower teams through coaching, feedback, development opportunities, removal of execution barriers, and cross-functional collaboration.

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; eligibility may vary by role.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager