Senior Manager, Global Medical Affairs- HIV

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
 

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
 

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description
 

We are seeking a Senior Manager within Phase 4 Research in HIV treatment 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 treatment. 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 Treatment 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 Treatment 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 Treatment 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 Treatment 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