Senior Director RWE Virology Product Area Lead HIV Treatment
Senior Director RWE Virology Product Area Lead HIV Treatment
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$ 261375 - 338250
1 Vacancy
Job Description
At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID19 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.
Every member of Gileads team plays a critical role in the discovery and development of lifechanging scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions and were 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.
Job Description
The RealWorld Evidence (RWE) function at Gilead is part of the Clinical Data Sciences (CDS) group within the Development organization and aims to unlock the power of RealWorld Data (RWD) to help transform innovations to lifechanging medicines for patients. The Senior Director RWE Virology Product Area Lead HIV Treatment reports to the Executive Director RWE Therapeutic Area (TA) HeadVirology and is accountable for the development and of the RWE strategy in support of HIV Treatment products under development. The incumbent will serve as the key RWE subject matter expert for the product(s) and all its indications across the development lifecycle representing RWE on Global Development Teams (GDTs) and Program Strategy Teams (PSTs) and serving 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 Area Lead HIV Treatment will oversee 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. 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 RWE at different stages of the product development and commercialization processes the ability to lead and manage crossfunctional efforts and resources and exceptional stakeholder management
Duties & Responsibilities
- Serve as the single point of accountability for the development and communication of the global RWE strategy supporting earlystage clinical development through postauthorization evidence needs for the HIV Treatment Product Area and its pipeline/lifecycle indications in Virology.
- Ensure the use of robust scientific methods and fitforpurpose data resources for the timely 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 postapproval studies.
- Provide functional perspective and subjectmatter 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 crossfunctional 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 Masters 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 postgraduation 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 earlystage 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 crossfunctional 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.
- Welldeveloped crosscultural sensitivity.
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Required Experience:
Exec
Employment Type
Full-Time
