Director, RWE Virology Safety Epidemiology

Director, RWE Virology Safety Epidemiology

Join the Director, RWE Virology Safety Epidemiology role at Gilead Sciences
.

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe.

We are open to candidates at Foster City, Cambridge (UK), or Stockley Park (UK).

• Responsible for the development, execution, and communication of specified RWE safety/non‑experimental studies for individual products and their pipeline/lifecycle indications in Virology.
• Provide functional perspective and subject‑matter expertise on RWE methods and requirements at both the global/regional level and the TA level, including review of RWE safety and PAS protocols and analysis plans developed internally and externally.
• Collaborate and coordinate safety, pediatrics, and PAS activities with RWE Virology Product teams.
• Employ robust scientific methods for the timely execution of safety, pediatrics, and PAS strategy in alignment with pipeline/lifecycle management objectives.
• Lead or contribute to a team of observational research scientists within a matrix organization to deliver, within time, budget, and quality standards, RWE safety/PAS including, but not limited to: patient registries, studies of natural history of disease, drug utilization studies, studies of patient reported outcomes, comparative effectiveness/safety studies, and post‑approval safety studies.
• Communicate effectively about the utility of RWE across the product lifecycle and contribute to the use of study results to support internal and external decisions.
• Communicate observational research results, including development of study reports and pertinent sections of regulatory documents, publications, white papers, press releases, etc.
• Represent the RWE function in internal cross‑functional teams and initiatives.
• Leverage close collaborations with quantitative functions within CDS (e.g., Biostatistics, Bioinformatics), as well as partners in Clinical Development, Global Patient Safety, Regulatory Affairs, Clinical Operations, Medical Affairs and Global Value and Access, to anticipate and meet the evidence needs of regulators, payers, providers, and patients.
• Identify the need for and contribute directly to the development of processes and delivery of training documents aimed at increasing the efficiency, quality, and impact of functional activities.
• Mentor junior epidemiologists to ensure competence in epidemiologic skills and knowledge.

• Doctoral degree (e.g. PhD, MD, ScD, Pharm
  
  D) in Epidemiology or related discipline, such as Outcomes Research, Medicine, Biostatistics from an accredited institution, with a minimum of 8+ years of relevant, post‑graduation experience with doctoral training OR
• Master’s degree (e.g. MSc) in Epidemiology or related discipline, such as Outcomes Research, Medicine, Biostatistics from an accredited institution with 10+ years of relevant experience with Master’s training
• Preferred: minimum of four (4) years of professional experience in the biopharmaceutical industry.
• Preference for understanding of the Virology therapeutic area, 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.
• Experience designing and conducting observational research, including protocol, statistical analysis plan, and study report development.
• Solid working knowledge of global regulatory guidelines pertaining to RWD and RWE studies, especially PAS.
• Ability to communicate proactively with others across functions to ensure shared purpose and clear accountability for future decisions.
• A strong track record of scientific publications demonstrating expertise in observational study design, analysis, and interpretation and direct experience with different applications of RWE, especially in support of PAS.
• Experience…