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We are seeking a Director within Phase 4 Research in Liver, Inflammation, Respiratory Viruses, and Established Products (LIVE) to join our Global Medical Affairs team. This role is responsible for leading the Phase 4 research strategy and execution for LIVE including leading and supporting Gilead Sponsored and Collaborative studies, and serving as the Team Lead for the LIVE Integrated Evidence Plan (IEP) Execution Team (ET). The ideal candidate will have previous experience in clinical and operational research, and significant knowledge in one or more of the therapeutic areas included in LIVE.

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

Specific Job Responsibilities

• Lead development of the Medical Affairs Research – LIVE strategic approach for data generation in alignment with LIVE Integrated Evidence Plans.
• Lead x-functional Execution Teams and facilitate the development of the LIVE data generation plans and activities in line with the IEP
• Lead/co-LEAD and/or contribute to the development of the IEPs across LIVE TAs
• Support the development and execution of, and represent MAR in, cross-functional data generation working groups for LIVE.
• Lead Gilead sponsored and collaborative research activities focused on the generation, interpretation, and communication of Real-World Data and Evidence and Clinical Outcomes Assessment (COA), including retrospective database analyses, prospective cohort studies, Patient Reported Outcomes (PRO) and implementation science studies.
• Provide high quality technical and methodological support to cross-functional teams to effectively use RW and COA data to optimize treatment practice and improve patient outcomes throughout the lifecycle of our medicines.
• Lead the development of communications (e.g., manuscripts, scientific forum presentations, slide decks) to build the peer reviewed published scientific evidence base.
• Maintain and continue to enhance knowledge of technical and methodological advances and trends to ensure best approaches are used in relevant studies and evaluations.
• Engage key clinical, methodologic, and TA experts and facilitate the building of relationships via collaboration on various projects. Provide support at advisory boards, regional educational programs, conferences and other external meetings.
• Advise on the development, deployment, and appropriate use of Medical Scientists field tools and resources (e.g. slide decks) and ensure correct interpretation and relevant messaging in these tools.
• Lead and support workshops and seminars to increase research capacity and literacy among MA and medical scientists and cross-functional stakeholders
• Provide administrative support in terms of coordination for project contracting and management.
• Adhere to all applicable pharmaceutical codes, Office of Inspector General (OIG) guidelines, and Gilead policies
• Exhibit Gilead’s core values: integrity, teamwork, accountability, excellence, and inclusion

Educational and other Requirements:

• Professional degree (eg, PhD, PharmD) with 8-plus years’ experience (or 4+ years with an MD) in clinical or observational research including research operations; OR master’s degree (eg, MS, MPH) with 10-plus 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
• Scientific knowledge/ experience in one of more of the specific TAs covered by LIVE
• Proven track-record in developing scientific abstracts and in published peer-reviewed manuscripts
• 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