Senior Manager, Global Medical Affairs- HIV Prevention

Description de l'emploi

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

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

Specific Job Responsibilities:

• Manage the HIV Prevention Phase 4 portfolio with oversight from the Research Committee Team Lead, and in collaboration with MA Scientific Leads, and key cross-functional partners such as Clinical Operations and local affiliates
  • Track, monitor and intervene with external investigators to ensure timely execution of contracted studies
  • Review abstracts and/or manuscripts that result from supported studies
  • Support closure of studies when not meeting contracted milestones

• Create and manage requests for proposals (RFPs) within the HIV Prevention 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
• Act as a resource of Phase 4 research within medical affairs and with x-functional colleagues in navigating the proposal and research process, including systems used for proposal review and approval, study contracting, and protocol reviews through protocol review boards
• Contribute or lead process improvements related to research proposal and study management systems
• Participate in HIV Prevention Execution Team meetings and update ET trackers as requested by the RC Team Lead or Research Strategy Lead to ensure inclusion of ISR and CO studies in data generation plans
• Participate in and support efficient execution of MA Global Study Review Committee (GRC) and Investigator Sponsored Research Review Committee (IRC).
• Manage projects to completion, anticipating obstacles and difficulties that may arise, resolving them in a collaborative manner under autonomy
• Work collaboratively with teams across Medical Affairs, Clinical Operations, Development Business Operations, Global Safety and Medical Communication
• Support the successful delivery of the HIV Prevention Global Medical Affairs Plan of Action

Educational and other Requirements:

• Professional degree (eg, PhD, PharmD) with 2-plus years of experience in clinical or observational research including research operations; OR master’s degree (eg, MS, MPH) with 6-plus years of experience; OR Bachelor’s degree with 8 years of experience
• Must be fully 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
• Comprehensive understanding/experience in MA/pharmaceutical industry in phase4/externally sponsored research programs or Clinical Development
• Scientific knowledge/experience in HIV
• 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
• Ability to apply logic and problem-solving skills under pressure, adapt to change, and successfully work independently and within the context of a team
• 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:

• Pharmaceutical industry experience in Phase 4 research
• Project management certification