Gilead Sciences, Inc.
Manager, Global Medical Affairs -- HIV Treatment
Gilead Sciences, Inc., Foster City, California, United States, 94420
Manager, Global Medical Affairs -- HIV Treatment
United States - California - Foster City | Medical Affairs Regular
We are seeking a Manager within Phase 4 Research to support HIV Treatment within Global Medical Affairs. 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 Treatment. The ideal candidate will have previous experience in Phase 4 research or clinical operations, and knowledge of one or more of relevant therapeutic areas.
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 Treatment.
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 Treatment 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.
Basic Qualifications
High School Degree and Eleven Years’ Experience
Associates Degree and Nine Years Experience
Bachelor's Degree and Seven Years’ Experience
Masters' Degree and Five Years’ Experience
Preferred Qualifications
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.
Understanding/experience in MA/pharmaceutical industry in phase4/externally sponsored research programs or Clinical Development.
Scientific knowledge/experience one or more of the relevant therapeutic areas.
People Leader Accountabilities
Create Inclusion
– knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
Develop Talent
– understand the skills, experience, aspirations, and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop, and realize their purpose.
Empower Teams
– connect the team to the organization by aligning goals, purpose, and organizational objectives and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
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We are seeking a Manager within Phase 4 Research to support HIV Treatment within Global Medical Affairs. 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 Treatment. The ideal candidate will have previous experience in Phase 4 research or clinical operations, and knowledge of one or more of relevant therapeutic areas.
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 Treatment.
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 Treatment 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.
Basic Qualifications
High School Degree and Eleven Years’ Experience
Associates Degree and Nine Years Experience
Bachelor's Degree and Seven Years’ Experience
Masters' Degree and Five Years’ Experience
Preferred Qualifications
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.
Understanding/experience in MA/pharmaceutical industry in phase4/externally sponsored research programs or Clinical Development.
Scientific knowledge/experience one or more of the relevant therapeutic areas.
People Leader Accountabilities
Create Inclusion
– knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
Develop Talent
– understand the skills, experience, aspirations, and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop, and realize their purpose.
Empower Teams
– connect the team to the organization by aligning goals, purpose, and organizational objectives and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
#J-18808-Ljbffr