Director RWE Oncology; Pharmacoepidemiology and Safety

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.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

The Real-World Evidence (RWE) function at Gilead is part of the Clinical Data Sciences (CDS) department within the Clinical Development organization and aims to unlock the power of Real-World Data (RWD) to help transform innovations to life-changing medicines for patients. The Director, RWE Oncology reports to the Senior Director, RWE Oncology Pharmacoepidemiology and Safety Lead and contributes to the development and execution of the RWE strategy in support of an Oncology Franchise through oncology product development and commercialization.

The incumbent will serve as an RWE pharmacoepidemiology and safety subject matter expert for Oncology interacting with pertinent indication sub-teams of the Global Development Team (s) (GDT) for the Franchise(s) and a strategic partner to clinical development, medical, patient safety, and commercial teams by the generation of RWE at the global level.

The Director, Real-World Evidence (RWE) Oncology Pharmacoepidemiology and Safety will design and deliver RWE required by internal stakeholders and regulators, ensuring timeliness, quality, and utility, as well as advise on methodological approaches including support of payer and provider interactions.

Success in this role requires a strong track record in the design and conduct of post authorization safety studies, rapid analyses to address ad hoc epidemiologic queries /analyses, direct expertise in use of RWE at different stages of the product development and commercialization processes, including early-stage clinical development, and the ability to manage effort and resources in a cross-functional, matrix setting.

Duties & Responsibilities:

• Serve as the single point of accountability for the timely development, execution, and communication of specified pharmacoepidemiology and safety studies for individual products and their pipeline/lifecycle indications in Oncology.
• 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 Pharmacovigilance and Safety analysis plans developed internally and externally.
• Ensure collaboration and coordination of Pharmacovigilance and Safety projects within RWE Oncology Product teams.
• Work within a matrix organization to deliver, within time, budget, and quality standards, post-authorization studies 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.
• Ensure fulfillment of observational study conduct requirements, such as registration, ethical board approval, protocol, SAP, study report development, and disclosure.
• Communicate effectively about the utility of RWE across the product lifecycle and drive use of study/analysis results to support internal and external decisions.
• Contr…