Senior Director, RWE Lead in Inflammation Therapeutic Areas (United States - California - Foster City)

This job is with Gilead Sciences Inc., an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

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.

The Real-World Evidence (RWE) 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.

We are seeking a Senior Director, RWE Inflammation Product Lead who will be accountable for the development and execution of the RWE strategy in support of one or more Inflammation products under development. The incumbent will serve as the key RWE subject matter expert within Gilead's lifecycle management teams for the product(s) 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, RWE Product Lead will provide leadership for 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., clinical development, regulators), as well as advise on methodological approaches in support of payer and provider interactions.

Success in this role requires a up-to-date knowledge of RWE/RWD use for regulatory purposes, a strategic mindset, and the ability to lead and deliver RWE strategies through strong cross-functional partnerships and external collaboration.

This role also 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, and the ability to lead and manage cross-functional efforts and resources.

The Senior Director, RWE Inflammation Product Lead reports to the Executive Director, RWE Therapeutic Area (TA) Head-Inflammation

Duties & Responsibilities

• Serve as the single point of accountability for the development, execution, and communication of the global RWE strategy supporting clinical development and regulatory submissions for a specific product/program and its pipeline/lifecycle indications in Inflammation.

• 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 DET/EMT objectives.

• Provide the functional perspective and subject-matter expertise, especially regarding regulatory use of RWE, as a member of the product DET/EMT.

• Provide leadership for 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 post-approval safety studies.

• 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., Risk Management Plan, 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.

​ Minimum Required Education and Years of Experience

• Bachelor's Degree and Fourteen Years' Experience OR

• Masters' Degree and Twelve Years' Experience OR

• PhD and Twelve Years' Experience

Preferred Qualifications:

•  Doctoral degree (e.g. PhD, ScD) and/or Master's degree (e.g. MSc) in Epidemiology 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 doctoral degree in epidemiology with leadership experience and primary focus on epidemiology evidence generation, especially for clinical development support, regulatory submission and safety are preferred.

• 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 experience in leading the development and execution of integrated RWE strategies to support clinical development programs, including alignment of evidence generation plans with overall development objectives.

• Demonstrated experience in providing strategic RWE leadership for regulatory filings/submissions, and interactions with global health authorities, including oversight of observational study design, analysis, and interpretation to support benefit-risk assessment, labeling discussions, and safety evaluations across development stages.

• Demonstrated understanding of the Inflammation therapeutic area, including disease knowledge, current treatment practice and guidelines, pertinent clinical trial endpoints and safety outcomes.

• 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.

People Leader Accountabilities:  

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams. 

• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose. 

• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.  

The salary range for this position is:

Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.