Manager, Global Medical Affairs- HIV Prevention

Arbeitsbeschreibung

We are seeking a Manager within Phase 4 Research in HIV Prevention to join our Global Medical Affairs team. This role is responsible for coordinating proposal reviews and supporting portfolio management of investigator-sponsored research (ISR), collaborative research, and MA-led Gilead-sponsored research in HIV Prevention. The ideal candidate will have previous experience in Phase 4 research or clinical operations, and knowledge of the therapeutic area.

This position is based at Gilead’s Foster City, CA location.

Specific Job Responsibilities:

• Manage the review of ISR, CO and MA-led GS proposals through Gilead’s Research Committee (RC) review process for HIV Prevention:
  • Coordinate proposal review meetings with RC Team Leads and RC Chairs
  • Support creation and management of requests for proposals (RFPs)
  • Support external investigators, MA scientific leads, Medical Scientists, and other stakeholders in developing and submitting rigorous research proposals to Gilead
• Support the management of the HIV Prevention Phase 4 portfolio including liaising with key cross-functional partners such as Clinical Operations, local affiliates and external investigators
• May review abstracts and/or manuscripts that result from the phase 4 program
• Contribute to ensuring that the research processes and study execution align with MA research policy and governance, integrated evidence plan priorities, and overall program strategy

• Work with Senior Manager to track, monitor and intervene with external investigators to ensure timely execution of contracted studies, and support closure of studies when not meeting contracted milestones

• Act as a resource for Research Committee Chairs, voting members, standing members, proposal champions and reviewers
• Contribute to process improvements related to research proposal and study management systems
• Manage projects to completion, anticipating obstacles and difficulties that may arise, resolving them in a collaborative manner and engage in project management activities as needed by assigned RC Team Lead and/or Senior Manager

Educational and other Requirements:

• Professional degree (eg, PhD, PharmD); OR master’s degree (eg, MS, MPH) with 4-plus years of experience in clinical or observational research including research operations; OR Bachelor’s degree with 6-plus years of experience
• Must be cognizant of and adhere to regulatory and legal (Business Conduct) requirements for clinical trials and other Medical Affairs activities; knowledge of FDA regulations, ICH guidelines and GCPs governing the conduct of clinical trials
• Demonstrated project management and organization skills including process improvement, management of multiple resources and priority projects with tight timelines while maintaining attention to detail
• Ability to work in a global environment which may require participation in meetings outside of standard work hours to accommodate time zone differences
• Affinity for a collaborative, team-oriented environment, and approach; must be able to appropriately interact within MA and across Development, senior management, and external customers/vendors
• Excellent interpersonal, written, and verbal communication skills
• Proven track record of executing clearly defined goals and objectives in a fast-paced environment
• Self-motivated to work independently and having a positive attitude while working as part of teams
• Ability to engage and manage multiple stakeholders to achieve the objective

Preferred Qualifications:

• Understanding/experience in in MA/pharmaceutical industry in phase4/externally sponsored research programs or Clinical Development
• Scientific knowledge/experience in HIV