Director, RWE Virology Safety Epidemiology

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 continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life‑changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

As a Director in Real‑World Evidence at Gilead you will

• Work in a team of observational research scientists within a matrix organization and advocate for the appropriate level of resources and methods to ensure the timeliness, quality, and utility of RWE Virology activities in support of safety required by internal and external stakeholders (e.g., regulators).
• Report to the Senior Director, RWE Safety Therapeutic Area Lead‑Virology and be responsible for the execution of RWE safety epidemiology studies across the product lifecycle, including pediatrics, post‑authorization studies (PAS), and other non‑experimental studies, both mandatory and voluntary, in support of Virology products.
• Serve as the key subject‑matter expert for Virology post‑marketing commitments (PMCs) and other pharmacoepidemiology activities in support of safety and serve as a partner to the RWE Virology Product teams and cross‑functional stakeholders to ensure excellence in the execution of all safety epidemiology activities at the global level.

The Real‑World Evidence (RWE) function at Gilead is part of the Clinical Data Sciences (CDS) group within the Development organization and aims to unlock the power of Real‑World Data (RWD) to help transform innovations into life‑changing medicines for patients.

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…