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Senior Director, Medical Affairs Research LIVE

美国 - 加利福尼亚州 - 福斯特市医疗事务正式员工

职位描述

Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives.

Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development.

Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them.

By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

We are seeking a talented Senior Director of Phase 4 Research in Liver, Inflammation, Respiratory Viruses, and Established Products (LIVE) to join our Global Medical Affairs team to help develop and lead execution of Gilead’s Medical Affairs-led LIVE research strategy, ensure alignment of research strategy with the clinical development plans and overarching asset strategy, serve as Gilead study lead for key interventional Phase 4 studies in LIVE, and help to oversee Gilead’s LIVE investigator sponsored research (ISR) program. The ideal candidate will be an established leader in clinical and/or implementation research in virology or inflammation with a strong completed research and publication record, and a deep understanding of the therapeutic areas (TA) under LIVE. This position will be based in Foster City.

Specific Job Responsibilities

  • Develop and lead execution of Gilead’s Medical Affairs-led LIVE research strategy

  • Lead and provide scientific and methodological expertise for Phase 4 interventional and implementation studies, in particular in support of new product launches for future assets

  • Oversee Gilead’s investigator sponsored research program in LIVE, including determining ISR funding priorities in line with Phase 4 integrated evidence plans (IEPs), oversight of RFP development and execution, and working with Gilead’s clinical operations team to manage the ISR portfolio

  • Lead and support the development of research communications (e.g., abstracts, manuscripts, scientific forum presentations, slide decks) to build the peer reviewed published evidence base from Phase 4 research

  • Ensure alignment of research strategy with the clinical development plans and overarching asset strategy

  • Lead and support Gilead LIVE cross-functional data generation efforts

  • Lead or serve as core member of IEP working groups in LIVE

  • Lead/co-Lead or participate in IEP execution teams (ETs) consolidate and coordinate data generation efforts cross-functionally to ensure IEP alignment and strategic data gap fulfillment of proposed and ongoing research efforts

  • Socialize data generation outputs to cross-functional senior and executive leadership

  • Provide strategic leadership and support of the MA Phase 4 research program proposal review process

  • Work with the Research Committee (RC) chair and team lead to ensure smooth execution of ISR and Gilead Sponsored proposal reviews

  • Lead the development of asset-specific RFPs to ensure high-quality, strategically aligned submissions from expert external investigators

  • Serve as standing member of the LIVE treatment global and investigator sponsored research committees (GRC/IRC): provide insight and guidance on study design, methodology and analysis plan feasibility and strategic alignment for study proposals.

  • Work with local medical affairs and other Phase 4 research teams in real world research and HEOR to ensure strategically aligned and high-quality local sponsored study proposals

  • Provide expert reviews of study protocols for functional (GMA) and cross-functional protocol review boards

  • Collaborate with the RC therapeutic area and process leads to ensure tracking of Phase 4 studies and impact measurement

  • Collaborate with the publications team in publications planning for key conferences and high-quality journals

  • Lead and provide expertise at advisory boards, conferences and other external meetings

  • 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:

  • Medical degree and/or advanced degree in a scientific, medical or public health discipline (Ph.D., MD, PharmD)

  • 10 years’ plus experience leading and conducting interventional (clinical and/or implementation) research in virology with specialized training in research methods

  • Proven publication track-record for research abstracts presented at major conferences and high-impact peer reviewed journals

Preferred Qualifications:

  • Research and/or clnical experience in TAs covered under LIVE

  • Community-based, PRO, qualitative and/or mixed methods research experience

  • Pharma / Biotech Industry experience

  • Proficiency in statistical and qualitative data analysis software packages, Microsoft Office suite and reference management software

  • Excellent written and verbal communication skills, with the ability to translate complex scientific concepts into clear and concise language for diverse audiences.

  • Strong attention to detail and ability to critically analyze data and scientific literature.

  • Strong organizational skills and ability to work independently.