Director, Real World Evidence Virology

Descripción del trabajo

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 Virology reports to the RWE Virology Product Lead and contributes to the development and execution of the RWE strategy in support of a Virology product through development and commercialization. The incumbent will serve as an RWE subject matter expert within pertinent indication subteams of the Global Development Team (GDT) for the product(s) and a strategic partner to clinical development, medical, and commercial teams by the generation of RWE at the global level.

The Director, RWE Virology 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 epidemiologic studies/analyses, direct expertise in use of RWE at different stages of the product development and commercialization processes, 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 development, execution, and communication of the global RWE strategy supporting clinical development and post-authorization evidence requirements for one or more pipeline/lifecycle indications for product(s) in Virology.

• Employ robust scientific methods and fit-for-purpose data for the timely execution of the RWE strategy, in alignment with the clinical development plan and broader GDT objectives.

• Generate, within time, budget, and quality standards, real-world evidence 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-authorization 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.

• Contribute to the communication of observational research results, including development of pertinent sections of regulatory documents, publications, white papers.

• Contribute to 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 RWE function in internal cross-functional teams and initiatives.

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

• Identify the need for and contribute directly to the development of processes and delivery of training aimed at increasing the efficiency, quality, and impact of functional activities.

• Mentor junior epidemiologists and RWE analysts to ensure competence in epidemiologic skills and knowledge.

Requirements

• Doctoral degree (e.g. PhD, MD, ScD, PharmD) and/or Master’s degree (e.g. MSc, MPH) in Epidemiology or related discipline, such as Outcomes Research, Medicine, Biostatistics from an accredited institution.

• Minimum of 10 years (with Master’s degree) or 8 years (with doctoral degree) of relevant, post-graduation experience; preference for a minimum of six (6) years of that experience to be in the biopharmaceutical industry.

• Direct experience with different applications of RWE, including in support of early-stage clinical development, regulatory approvals, and/or safety commitments.

• Experience designing and conducting observational research, including protocol, statistical analysis plan, and study report development.

• Experience with secondary data analysis, including electronic medical record and/or medical claims databases, and with statistical analysis tools, such as SAS and R.

• A track record of scientific publications demonstrating expertise in observational study design, analysis, and interpretation is preferred.

• Knowledge of the Virology therapeutic area.

• Experience leading studies and projects in a matrix setting.

• Demonstrated ability to function with autonomy and develop productive cross-functional collaborations.

• Ability to manage priorities, resources, and performance targets.

• Well-developed cross-cultural sensitivity.