Director, Oncology Epidemiology

About This Role

The Director, Oncology Epidemiology will lead real-world evidence research projects within the Global Epidemiology team, overseeing study design, data analysis, and scientific dissemination. This role involves close collaboration with colleagues and multi-disciplinary teams to inform product teams and regulatory agencies.

Responsibilities

• Identify research study needs, draft proposals and protocols, and contribute to real-world evidence (RWE) strategy and study conduct.
• Collaborate with Epidemiology colleagues to define research questions, develop epidemiological protocols, conduct analyses, and communicate evidence.
• Participate in multi-disciplinary matrix teams to address issues where real-world data (RWD)/RWE can inform decisions.
• Provide epidemiological and/or statistical consulting and support to compound/product teams, and disseminate technical information.
• Assess feasibility of fit-for-purpose RWD, research natural history of diseases, perform statistical risk assessments, and use historical data to contextualize safety issues.
• Design and conduct post-authorization safety activities, including rapid analytics for signal strengthening and formal evaluation studies.
• Support efforts for the Office of the Chief Medical Officer and cross-sector collaborations.
• Promote the use of standardized tools to support real-world evidence generation.
• Keep up to date with changes in the external environment and advocate as a subject matter expert regarding RWE guidance/framework for regulatory decision making.

Requirements

• PhD in Epidemiology or a closely related field OR MD with training and degree in Epidemiology or a closely related field OR Master’s degree with at least 6 years of hands-on experience
• At least 5 years of Epidemiology research experience
• Understanding and ability to apply and interpret quantitative methods
• Experience writing observational study protocols, proposals, and proposal requests, particularly method sections
• Experience working with large administrative or medical records databases
• Background in the epidemiologic landscape of oncology including related conditions and therapies
• Track record of authoring scientific communications (peer-reviewed publications, poster or oral presentations, technical reports)

Qualifications

• PhD in Epidemiology or a closely related field OR MD with training and degree in Epidemiology or a closely related field OR Master’s degree with at least 6 years of hands-on experience
• At least 5 years of Epidemiology research experience is required.

Nice to Have

• Experience working with health authorities
• Product development experience in the pharmaceutical industry
• Experience working in a global, cross-functional team environment

Skills

* Required skills

Benefits