Overview
Director, RWE Virology Safety Epidemiology – United Kingdom (Uxbridge, Cambridge) in Pharmacovigilance & Epidemiology. This role is part of the Real-World Evidence (RWE) function within Clinical Data Sciences and focuses on RWE safety epidemiology across the product lifecycle for Virology products. Open to candidates in Foster City, Cambridge (UK), or Stockley Park (UK).
Responsibilities
* Lead the development, execution, and communication of specified RWE safety/non-experimental studies for individual Virology products and their pipeline/lifecycle indications.
* Provide functional perspective and subject-matter expertise on RWE methods at global/regional and TA levels, including review of RWE safety and PAS protocols and analysis plans.
* Collaborate with RWE Virology Product teams on safety, pediatrics, and PAS activities.
* Apply robust scientific methods for timely execution of safety, pediatrics, and PAS strategies aligned with pipeline/lifecycle management goals.
* Lead or contribute to a matrix team of observational research scientists to deliver RWE safety/PAS within time, budget, and quality standards (e.g., patient registries, natural history studies, drug utilization, PROs, comparative safety/efficacy, post-approval safety).
* Communicate the utility of RWE across the product lifecycle and support use of study results in internal and external decisions.
* Produce study reports and relevant sections of regulatory documents, publications, white papers, and press materials as appropriate.
* Represent the RWE function in internal cross-functional teams and initiatives.
* Collaborate with quantitative functions (Biostatistics, Bioinformatics) and partners in Clinical Development, Global Patient Safety, Regulatory Affairs, Clinical Operations, Medical Affairs, and Global Value and Access to meet regulator, payer, provider, and patient evidence needs.
* Develop processes and training materials to improve efficiency, quality, and impact of RWE activities.
* Mentor junior epidemiologists to build epidemiologic skills and knowledge.
Qualifications
* Doctoral degree (PhD, MD, ScD, PharmD) in Epidemiology or related discipline with 8+ years post-graduate experience, or
* Master’s degree in Epidemiology or related discipline with 10+ years of post-graduate experience; relevant experience in the biopharmaceutical industry preferred.
* Strong understanding of Virology therapeutic area, current treatment practices, guidelines, endpoints, and safety outcomes.
* Expertise in state-of-the-art methods, including AI/ML approaches, for leveraging RWD to assess safety and other questions.
* Experience designing and conducting observational research (protocols, SAPs, study reports).
* Solid knowledge of global regulatory guidelines for RWD and RWE studies, especially PAS.
* Strong communication skills across functions to ensure shared purpose and accountability.
* Proven track record of scientific publications in observational study design, analysis, and interpretation; experience with RWE applications in PAS.
* Experience managing vendor relationships, leading studies, projects, and people in a matrix setting.
* Ability to work autonomously and develop cross-functional collaborations; strong prioritization and resource management in a changing environment.
People Leader Accountabilities
* Create Inclusion – model and embed inclusion and diversity in team management.
* Develop Talent – coach and provide feedback to grow employee performance and potential.
* Empower Teams – align goals and provide support to remove barriers and connect teams to the broader organization.
Equal Employment Opportunity (EEO)
Gilead Sciences, Inc. and its subsidiaries and affiliates are an equal opportunity employer. All employment actions are non-discriminatory and comply with applicable laws. Gilead prohibits discrimination based on protected characteristics and any other characteristics protected by law.
For Current Gilead Employees and Contractors
Please apply via the Internal Career Opportunities portal in Workday.
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