Sr. Director, RWE - Oncology - PAS (Post Authorization Studies)
United States - California - Foster City
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to apply for this job.Job DescriptionSr. Director, RWE - Oncology - Post Authorization Studies (PAS)Site Locations Include: Stockley Park, UK (preferred)| Will also consider candidate for offices located in Foster City, CA | Raleigh, NC | Seattle, WA | Washington, D.C. and Morris Plains, NJ Job Description Summary
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. The Senior Director, RWE Oncology Post Authorization Studies (PAS) Lead reports to the Executive Director, RWE Therapeutic Area (TA) Head-Oncology and has primary accountability for the execution of post authorization and other non-experimental studies, both mandatory and voluntary, in support of Oncology products for Gilead and Kite. The incumbent will serve as the key PAS subject matter expert for Oncology and serve as a strategic partner to the RWE Oncology Product Leads and cross-functional stakeholders to ensure excellence in the execution of PAS at the global level.
The SD, RWE Oncology PAS Lead will oversee a team of RWE scientists within a matrix organization and advocate for the appropriate level of resources to ensure the timeliness, quality, and utility of PAS required by internal and external stakeholders (including regulators). Success in this role requires excellence in communication and stakeholder management, design and conduct of epidemiologic studies, direct expertise in use of RWE and application of appropriate and contemporary analytical methods at different stages of the product development and commercialization processes, and the ability to lead and manage cross-functional efforts and resources.
The SD, RWE Oncology PAS lead will be responsible for maintaining an up to date overview of the mature oncology products in Gilead and Kite and communicating on time and effectively with the SD Franchise Oncology leads in RWE to determine which studies are likely to be in consideration and plan for the development of PAS studies in good time. The SD RWE Oncology lead will also be required to work effectively with the Global Medical Affairs leads and local country Medical Affairs leads to ensure smooth set up of studies and ensure good communication throughout study timeline.Site Locations Include: Stockley Park, UK (preferred)| Foster City, CA | Raleigh, NC | Seattle, WA | Washington, D.C. | Morris Plains, NJ Duties & Responsibilities
- Serve as the primary point of accountability for the timely development, execution, and communication of specified post-authorization/non-experimental studies for individual products and their pipeline/lifecycle indications in Oncology.
- Provide functional perspective and subject-matter expertise on RWE methods and requirements at both the global/regional level and the TA level, including review of PAS protocols and analysis plans developed internally and externally.
- Ensure collaboration and coordination of PAS activities with RWE Oncology Product teams
- Lead a team of observational research scientists within a matrix organization to deliver, within time, budget, and quality standards, post-authorization studies including, but not limited to: patient registries, studies of natural history of disease, drug utilization studies, studies of patient reported outcomes, comparative effectiveness/safety studies, and post-approval safety studies.
- Communicate effectively about the utility of RWE and drive use of study results to support internal and external decisions.
- Ensure expert communication of observational research results, including development of study reports and pertinent sections of regulatory documents, publications, white papers, press releases, etc.
- 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 partners in Clinical Development, Global Patient Safety, Regulatory Affairs, Clinical Operations, 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.
- 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 PAS.
- Preference for understanding of the Oncology therapeutic area, including disease knowledge, current treatment practice and guidelines, pertinent clinical trial endpoints and safety outcomes.
- Solid working knowledge of regulatory guidelines pertaining to RWD and RWE studies, especially post-authorization studies.
- 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.
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