Gilead Sciences, Inc.
Senior Manager, Global Medical Affairs- HIV Treatment
Gilead Sciences, Inc., Foster City, California, United States, 94420
Senior Manager, Global Medical Affairs- HIV Treatment
United States - California - Foster City Medical Affairs Regular
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 cross-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 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
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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 cross-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 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
#J-18808-Ljbffr