About the position
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
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.
- 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.
Benefits
- Company-sponsored medical, dental, vision, and life insurance plans.
- Discretionary annual bonus.
- Discretionary stock-based long-term incentives.
- Paid time off.
