Executive Director, Real World Evidence TA Head - Inflammation

The Real-World Evidence (RWE) function at Gilead is part of the Clinical Data Sciences (CDS) group 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 Executive Director, RWE Therapeutic Area (TA) Head-Inflammation reports to the VP, RWE and is accountable for the development and execution of the RWE strategy in support of all Gilead Inflammation products across the development lifecycle. The incumbent will serve as the key RWE subject matter expert across the Inflammation therapeutic area (TA) and serve 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 Executive Director, RWE TA Head-Inflammation will develop a team of observational research scientists and maintain 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 ensure methodological and analytical capabilities are deployed in support of payer and provider interactions. In addition, and as a member of the RWE Leadership Team (LT), the incumbent will be expected to directly shape the growth of the RWE function as a key contributor of evidence-based decisions within the Gilead Development organization.

Success in this role requires extensive experience in the pharmaceutical industry, deep knowledge of epidemiologic methods, seasoned expertise in use of RWE at different stages of the product development and commercialization processes, demonstrated ability to influence internal partners and external stakeholders, as well as a natural ability to lead and inspire.

Duties & Responsibilities:

Serve as the single point of accountability for the development, execution, and communication of the entire portfolio of global RWE strategies supporting early-stage clinical development and post-authorization evidence requirements in Inflammation

Ensure the deployment of innovative and robust scientific methods and capabilities in support of internal and external decisions, with a particular focus on regulatory use of RWE, across the product development lifecycle in a way that positions Gilead as a leader in RWE

Serve on Inflammation-specific review and governance committees, providing functional perspective and subject-matter expertise and ensuring resource planning and alignment.

Oversee the recruitment, expansion, and retention of an expert RWE team, by providing clarity of purpose, commitment to professional development, and focus on execution excellence

Lead a team of observational research scientists to deliver, on time and within budget, 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 post-approval safety studies

Establish close collaborations with quantitative functions within CDS (e.g., Biostatistics, Bioinformatics), as well as in Clinical Research, Medical Affairs, and Global Value and Access to anticipate and meet the evidence needs of regulators, payers, providers, and patients

Maintain a high level of awareness regarding the external landscape regarding innovative methods and uses of RWE, especially for regulatory decisions

Develop an external strategic partnership plan, in collaboration with the RWE Generation group, to represent Gilead in interactions with academic, policy, and research groups

Ensure timely and appropriate development of epidemiological sections of regulatory documents for agencies worldwide (e.g., RMP, orphan or breakthrough designations, PIP, query responses, advisory committee briefing documents)

Contribute to the development of processes and training documents aimed at increasing the efficiency, quality, and impact of functional activities

Minimum Qualifications:

Doctoral degree (e.g. PhD, MD, ScD, PharmD) and/or Master's degree (e.g. MSc) in Epidemiology or related discipline, such as Outcomes Research, Medicine, Biostatistics from an accredited institution, with a minimum of fourteen (14) years of relevant, post-graduation experience; preference for a minimum of eight (8) years of that experience to be in the biopharmaceutical industry

Demonstrated subject-matter expertise regarding strategic use of RWE throughout the product lifecycle, especially in support of early-stage clinical development and regulatory approvals, with a strong track record of evidence generation and scientific publications, as well as recognized thought leadership

Deep understanding of the Inflammation therapeutic area, including knowledge of disease, clinical practice, and clinical development challenges

Established experience leading and developing teams, especially during times of organizational growth

Experience of managing change with a positive approach to the challenges for self, team, and the business

Demonstrated ability to set and manage priorities, resources, performance targets, and initiatives in a global environment

Commitment to creating a culture of accountability, by consistently role modeling and clearly communicating its importance to drive performance across the organization

Commitment to investing in others' development to build and strengthen a diverse talent pipeline for RWE and for Gilead

Ability to influence and achieve goals while maintaining productive organizational relationships

Well-developed cross-cultural sensitivity