Director, Real-World Evidence Oncology (Post Authorization Studies)

Duties & Responsibilities

• Responsible for the 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.
• Collaborates and coordinates PAS activities with RWE Oncology Product teams.
• Employ robust scientific methods for the timely execution of PAS strategy in alignment with pipeline/lifecycle management objectives.
• Lead or contribute to 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 across the product lifecycle and contribute to the use of study results to support internal and external decisions.
• Communicates 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 teams and initiatives.
• Leverage 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.
• Identify the need for and contribute directly to the development of processes and delivery of training documents aimed at increasing the efficiency, quality, and impact of functional activities.
• Mentor junior epidemiologists to ensure competence in epidemiologic skills and knowledge.

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 eight (8) years of relevant, post-graduation experience with doctoral training, or ten (10) years with Master's training; preference for a minimum of four (4) years of that experience to be in the biopharmaceutical industry.
• Preference for understanding of the Oncology therapeutic area, including disease knowledge, current treatment practice and guidelines, pertinent clinical trial endpoints and safety outcomes.
• Experience designing and conducting observational research, including protocol, statistical analysis plan, and study report development.
• Solid working knowledge of regulatory guidelines pertaining to RWD and RWE studies, especially post-authorization studies.
• Ability to communicate proactively with others across functions to ensure shared purpose and clear accountability for future decisions.
• A 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.
• Experience leading studies, projects and people in a matrix setting.
• Demonstrated ability to function with autonomy and develop productive cross-functional collaborations.
• Ability to manage priorities, resources, and performance targets, in a changing environment.
• Well-developed cross-cultural sensitivity.

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