Sr Director, Epidemiology and Real World Evidence Franchise Lead (Oncology)

Gilead Sciences•Foster City, CA

6d•$237,575 - $338,250•Onsite

About The Position

The Epidemiology and Real-World Evidence (EpiRWE) 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 Senior Director, EpiRWE Oncology Franchise Lead in Early Development reports to the Executive Director, EpiRWE Therapeutic Area (TA) Head-Oncology and is accountable for the development and execution of the RWE strategy in support of one or more Oncology Franchises under development. The incumbent will serve as the key EpiRWE subject matter expert within the Early Development teams (Gilead Asset Team (GAT), Early Molecule Teams (EMTs) and Development Evidence Teams (DETs)) for the relevant products within an Oncology Franchise and all its indications across the development lifecycle 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 SD, EpiRWE Oncology Franchise Lead will ensure the timeliness, quality, and utility of EpiRWE 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 EpiRWE at early stages of the product Oncology Franchise development process, and the ability to lead and manage cross-functional efforts and resources.

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 Epidemiology and RWE, especially in support of early-stage clinical development and regulatory approvals.
Demonstrated understanding of the Oncology therapeutic area, including disease knowledge, current treatment practice and guidelines, pertinent clinical trial endpoints and safety outcomes.
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.

Responsibilities

Serve as the single point of accountability for the development, execution, and communication of the global EpiRWE strategy supporting early-stage clinical development evidence requirements for a specific Oncology Franchise and its pipeline/lifecycle indications in Oncology.
Ensure the use of robust scientific methods and fit-for-purpose data resources for the timely execution of the EpiRWE strategy, in alignment with the clinical development plan and broader EMT, DET and GAT objectives.
Provide the functional perspective and subject-matter expertise, especially regarding regulatory use of EpiRWE, as a member of the EMTs and situational member of the DET.
Deliver, within time, budget, and quality standards, proactive EpiRWE 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 and comparative safety and effectiveness research.
Communicate effectively about the utility of EpiRWE across the product Oncology Franchise lifecycle and drive use of study/analysis results to support internal and external decisions across the Franchise.
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., Risk Management Plan, orphan or breakthrough designations, Pediatric Investigation Plan, query responses, advisory committee briefing documents).
Represent the EpiRWE 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, Clinical Pharmacology), 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.