Senior Director, RWE Virology Product Area Lead - HIV Treatment

About Gilead

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: Senior Director, RWE Virology Product Area Lead – HIV Treatment

Position Description 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 to life-changing medicines for patients. The Senior Director, RWE Virology Product Area Lead – HIV Treatment reports to the Executive Director, RWE Therapeutic Area (TA) Head-Virology and is accountable for the development and execution of the RWE strategy in support of HIV Treatment products under development. The incumbent will serve as the key RWE subject matter expert for the product(s) and all its indications across the development lifecycle, representing RWE on Global Development Teams (GDTs) and Program Strategy Teams (PSTs) and serving as a strategic partner to clinical development, medical, and commercial teams to ensure excellence in the generation and use of RWE at the global level.

The SD, RWE Product Area Lead – HIV Treatment will oversee a team of observational research scientists and advocate for the appropriate level of resources to ensure the timeliness, quality, and utility of RWE required by internal and external stakeholders (e.g., regulators), as well as advise on methodological approaches in support of payer and provider interactions. Success in this role requires excellence in design and conduct of epidemiologic studies/analyses, direct expertise in use of RWE at different stages of the product development and commercialization processes, the ability to lead and manage cross-functional efforts and resources, and exceptional stakeholder management.

Duties & Responsibilities

• Serve as the single point of accountability for the development, execution, and communication of the global RWE strategy supporting early-stage clinical development through post-authorization evidence needs for the HIV Treatment Product Area and its pipeline/lifecycle indications.
• Ensure the use of robust scientific methods and fit-for-purpose data resources for the timely execution of the RWE strategy, in alignment with the clinical development plan and broader GDT/PST objectives.
• Lead a team of observational research scientists to deliver, within time, budget, and quality standards, proactive RWE generation including, but not limited to: natural history of disease, population characterization, assessment of treatment patterns and unmet need, development of external comparators, benchmarking of clinical outcomes, comparative safety and effectiveness research, and voluntary post-approval studies.
• Provide functional perspective and subject-matter expertise, especially regarding strategic and regulatory use of RWE, to the product GDT, either as a member or via a delegate.
• Communicate