Director, RWE - Virology - HIV
Gilead
- Foster City, CA
- Permanent
- Full-time
- Serve as the single point of accountability for the development, execution, and communication of the global RWE strategy supporting established products evidence requirements for the treatment of HIV.
- Employ robust scientific methods and fit-for-purpose data for the timely execution of the RWE strategy, in alignment integrated evidence plans and broader strategy 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 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 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.
- Doctoral degree in Epidemiology from an accredited institution. A clinical degree (PharmD, M.D, e.g.) combined with a Master’s degree (M.H.S, MSc, MPH) in epidemiology from a(n) accredited institution will be considered.
- Demonstrable proficiency 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.
- Six (6) years of relevant experience in the biopharmaceutical industry, preferably within cross functional teams.
- Direct experience with different applications of RWE, including in established product support, regulatory approvals, and/or safety commitments.
- Minimum of five years working in the HIV 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.
- Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.