Senior Director, Obs Studies, Medical Affairs Research

Gilead Sciences•Foster City, CA

About The Position

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. Medical Affairs Research is a core strategic function within Global Medical Affairs, providing scientific leadership and evidence generation across the product lifecycle. As a team within MAR, the Post-Authorization Research & Innovation in Study Methodology (PRISM) drives the selection and implementation of state-of-the-art research methodologies for post-authorization (Phase 4) medical affairs research across therapeutic areas. The Senior Director RWE for PRISM reports to the Executive Director of PRISM and will serve as the key subject matter expert for the scientific and operational execution of RWE studies, as well as hybrid studies. You will partner closely with the MAR Therapeutic Leaders to define asset-appropriate lifecycle evidence strategies and ensure their integration into Integrated Evidence Plans (IEPs). As a senior Medical Affairs leader, you will influence enterprise governance, shape cross-functional decision-making, and represent Medical Affairs perspectives on research innovation, feasibility, and impact. Additional leadership or oversight responsibilities may include, but are not limited to, additional study or investigator documentation, contributions to data analysis plans, study reporting, and clinical development inputs into regulatory documentation, publications and scientific presentations. Success in this role requires excellence in design and conduct of epidemiologic studies, expertise in the use of data from both primary as well as secondary sources (e.g., from administrative claims, medical records, etc.), expertise in the use and application of appropriate and state-of-the-art analytical methods at different stages of the product development and commercialization lifecycle, and the ability to lead and manage cross-functional efforts and resources. Provide functional perspective and subject-matter expertise on RWE methods and requirements at both the MAR and Regional/Affiliate Medical Affairs TA level, including review of study protocols and analysis plans developed internally, in study collaborations and submitted as Investigator Initiated Research Partner with Clinical Development, Regulatory Affairs, Patient Safety, HEOR, and Commercial colleagues.

Requirements

Doctoral degree (e.g. PhD, MD, ScD, PharmD) and/or Master’s degree (e.g. MSc) in Epidemiology or related discipline, such as Outcomes Research, Medicine, Biostatistics from an accredited institution, with a minimum of twelve (12) years of relevant, post-graduation experience; preference for a minimum of six (6) years of that experience to be in the biopharmaceutical industry.
A strong track record of scientific publications demonstrating expertise in observational study design, analysis, and interpretation and direct experience with different applications of RWE.
Solid working knowledge of regulatory guidelines pertaining to RWD and RWE studies, especially post-authorization studies.
Experience leading, coaching, and managing people in a global, matrixed setting.
Demonstrated ability to function with a high level of autonomy and develop productive cross-functional collaborations.
Ability to manage priorities, resources, and performance targets, in a changing environment.
Ability to communicate proactively with others across functions to ensure shared purpose and clear accountability for future decisions.
Well-developed cross-cultural sensitivity.

Nice To Haves

Preference for understanding of the Virology and Oncology therapeutic areas, including disease knowledge, current treatment practice and guidelines, pertinent clinical trial endpoints and safety outcomes.
Strong preference for expertise in state-of-the-art methods, including AI/ML approaches, for leveraging RWD to assess safety and other questions

Responsibilities

Communicate effectively about the utility of RWE and drive use of study results to support internal and external decisions.
Ensure expert communication of observational research results supported by MAR, including development of study reports and pertinent sections of regulatory documents, publications, white papers, press releases, etc.
Foster close collaborations and align processes with key internal partner functions, including CDS-RWE, HEOR, Biostatistics and AI/ML Research Center.
Partner effectively with Clinical Development Therapeutic Areas, Clinical Operations, Regulatory Affairs, Patient Safety, and Commercial colleagues.
As assigned, leads or otherwise oversees and directs the study protocol design, execution and reporting.
Ensure compliance with global regulatory requirements, patient safety standards, GCP, and Gilead policies.
Establish and maintain external scientific and thought-leader relationships.
Consult with Development colleagues who request assistance in implementing novel RWE approaches in earlier stage clinical trials (eg decentralized clinical trials).
Represent Gilead Medical Affairs through scientific presentations and publications.
Represent the MAR function in internal cross-functional initiatives and external organizations, such as industry associations, professional societies, or regulatory working groups.
Actively identify the need for the development of processes or gaps in training documents aimed at increasing the efficiency, quality, and impact of functional activities.

Benefits

This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
Benefits include company-sponsored medical, dental, vision, and life insurance plans.
For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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