Senior Director, RWE Virology Product Area Lead – HIV Treatment

Descrizione del lavoro

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 in Virology.
• 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 effectively about the utility of RWE across the product lifecycle and drive use of study/analysis results to support internal and external decisions.
• Ensure expert communication of observational research results, including development of pertinent sections of regulatory documents, publications, white papers, press releases, etc.
• Oversee timely and appropriate development of epidemiological sections of regulatory documents for agencies worldwide (e.g., orphan or breakthrough designations, Pediatric Investigation Plan, query responses, advisory committee briefing documents).
• Represent the RWE function in internal cross-functional initiatives and external organizations, such as industry associations, professional societies, or regulatory working groups.
• Foster close collaborations with quantitative functions within CDS (e.g., Biostatistics, Bioinformatics), as well as in Research, Clinical Research, Medical Affairs, and Global Value and Access to anticipate and meet the evidence needs of regulators, payers, providers, and patients.
• Actively identify the need for the development of processes or gaps in training documents aimed at increasing the efficiency, quality, and impact of functional activities.

Requirements

• 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 twelve (12) years of relevant, post-graduation experience; preference for a minimum of six (6) years of that experience to be in the biopharmaceutical industry.
• 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 early-stage clinical development and regulatory approvals.
• Demonstrated understanding of the Virology therapeutic area, including disease knowledge, current treatment practice and guidelines, pertinent clinical trial endpoints and safety outcomes. Specific expertise in HIV epidemiology strongly preferred.
• Experience leading, coaching, and managing people in a global setting.
• Demonstrated ability to function with a high level of autonomy and develop productive cross-functional collaborations.
• Ability to manage priorities, resources, and performance targets, in a changing environment.
• Ability to communicate proactively with others across functions to ensure shared purpose and clear accountability for future decisions.
• Well-developed cross-cultural sensitivity.