Senior Director, Epidemiology

The Opportunity:

The Senior Director, Epidemiology is responsible for leading the strategy and execution of epidemiology plans and activities for Revolution Medicines assets and/or indications. They will be accountable for working across the clinical development, safety, medical affairs, and commercial matrix developing strategies and overseeing execution of key epidemiology deliverables. Reporting to the Executive Director, Head of Epidemiology, they will closely align with the Global Patient Safety organization to provide epidemiologic context to potential safety signals, inform the benefit/risk of Rev Med products, and contribute to the design and execution of post-approval safety studies, globally. This is an exceptional opportunity to contribute to the advancement of oncology by generating innovative real-world evidence that will shape the future of patient care.

• The Senior Director, Epidemiology will lead the epidemiology strategy for a given asset and/or indication, including developing plans for epidemiology deliverables (e.g., systematic literature reviews, natural history studies, clinical trial design and optimization, comparative effectiveness and safety, post-approval safety studies, and healthcare resource utilization analyses).

• Designs and executes deliverables in accordance with the plan, either personally or through oversight of other epidemiologists/vendors/contractors; this may involve the development of templates and SOPs, as well as authoring protocols, SAPs, clinical study reports, slide decks, abstracts, posters, and peer-reviewed manuscripts.

• Provides epidemiology leadership to Clinical Development, Global Patient Safety, Regulatory Affairs, Medical Affairs, and Commercial activities across the medicines development life cycle.  Active participation on cross-functional teams.  Lead sub-team meetings as appropriate.

• Ensures epidemiology point of view is included in key deliverables from other functions such as clinical trial protocols, SAPs, case report forms, regulatory submissions and payer interactions within assigned indications and/or therapeutic areas.

• Lead activities related to scientific manuscripts, clinical conference abstracts, presentations, and posters based on observational study data.

• Represents HEOR/RWE department during interactions with key external stakeholders including Scientific Advisory Boards and regulatory authorities.

• Appraises and synthesizes relevant epidemiological and RWE literature and regulatory guidance documents.

Required Skills, Experience and Education:

• PhD / DSc / DrPH in epidemiology or a relevant advanced science degree with and at least 12 years of related industry experience at a sponsor/pharmaceutical company.

• Demonstrated technical knowledge of pharmacoepidemiologic methods and real-world oncology data sets as well as the use of appropriate biostatistical methods.

• History of publications demonstrating the successful design, execution and communication of epidemiologic research.

• Knowledge of drug and clinical development process for genomic/targeted medicines.

• Excellent analytic and problem-solving skills.

• Excellent attention to detail and quality, and scientific rigor.

• Strong interpersonal skills and the ability to work effectively in multidisciplinary teams, including ability to provide oversight to vendors.

• Existing external relationships to foster collaborative and timely research.

Preferred Skills:

• 12+ years of oncology pharmacoepidemiology experience at a sponsor/pharmaceutical company.

• Experience driving from conception to completion post-approval safety studies using RWD submitted to global regulators. 

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