Director – Real-World Evidence (RWE) Virology Safety Epidemiology
Department: Pharmacovigilance & Epidemiology
Employment Type: Full-Time
Location: Foster City, California, United States – Onsite / Hybrid Eligible
About Gilead Sciences:
Gilead Sciences is a global biopharmaceutical leader dedicated to creating a healthier world for all. For over 35 years, Gilead has pioneered breakthroughs in HIV, viral hepatitis, COVID-19, cancer, and other therapeutic areas, providing innovative therapies to improve patient outcomes worldwide.
Position Overview:
Gilead is seeking an experienced Director to lead Real-World Evidence (RWE) safety epidemiology for Virology products. This role is critical in ensuring timely, high-quality, and scientifically rigorous RWE studies that support product safety across the lifecycle, including pediatrics, post-authorization studies (PAS), and other non-experimental studies. The Director will serve as a subject-matter expert, collaborating across functions to execute global RWE strategies in Virology.
Key Responsibilities:
Lead and execute RWE safety/non-experimental studies for Virology products, including post-marketing commitments (PMCs), pediatric studies, and PAS.
Provide functional expertise on RWE methods, global and regional regulatory requirements, and study design for internal and external stakeholders.
Collaborate with RWE Virology Product teams and cross-functional stakeholders to ensure alignment with safety, regulatory, and lifecycle management objectives.
Manage teams of observational research scientists within a matrix organization, delivering studies on time, within budget, and meeting quality standards.
Oversee study types including patient registries, natural history studies, drug utilization, patient-reported outcomes, comparative effectiveness, and post-approval safety studies.
Communicate study results effectively through reports, regulatory documents, publications, and other scientific communications.
Mentor junior epidemiologists to enhance competencies and ensure high-quality execution of RWE activities.
Partner with Clinical Development, Global Patient Safety, Regulatory Affairs, Medical Affairs, and other functions to meet evidence needs for regulators, payers, providers, and patients.
Identify and implement process improvements and training initiatives to increase efficiency and quality within the RWE function.
Qualifications:
Required:
Doctoral degree (PhD, MD, PharmD, ScD) in Epidemiology, Outcomes Research, Biostatistics, Medicine, or related discipline with 8+ years post-graduate experience.
OR Master’s degree with 10+ years of relevant experience.
Preferred:
Minimum 4 years’ experience in the biopharmaceutical industry.
Strong understanding of Virology therapeutic area, disease knowledge, treatment guidelines, clinical endpoints, and safety outcomes.
Expertise in contemporary RWE methods, including AI/ML applications for safety and epidemiology.
Proven experience designing and conducting observational research, including protocol development, statistical analysis plans, and study reports.
Knowledge of global regulatory guidelines for RWE and PAS studies.
Experience managing vendors, leading projects, and mentoring teams in a matrix environment.
Demonstrated scientific publications showcasing expertise in RWE and observational research.
Excellent cross-functional collaboration, communication, and leadership skills.
People Leadership Responsibilities:
Create Inclusion: Foster diverse teams and embed inclusion in management practices.
Develop Talent: Coach team members on performance, career growth, and skill development.
Empower Teams: Align team goals with organizational objectives, remove barriers, and ensure accountability.
Compensation & Benefits:
Salary Range: $226,185 – $292,710 (base compensation varies based on experience, qualifications, and location).
Eligible for discretionary annual bonus, stock-based long-term incentives, paid time off, and company-sponsored medical, dental, vision, and life insurance plans.
Equal Opportunity Employer:
Gilead Sciences is committed to diversity, equity, and inclusion. Employment decisions are made without regard to race, color, religion, gender, sexual orientation, age, disability, veteran status, or other protected characteristics. Reasonable accommodations are available for applicants with disabilities.
Application Instructions:
Apply now to join Gilead Sciences and lead cutting-edge RWE Virology safety initiatives that impact patient care globally.
Job Requisition ID: R0049281
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