Director, Oncology Epidemiology

About This Role

The Director, Oncology Epidemiology will independently oversee various epidemiology and real-world evidence research projects within the Global Epidemiology team. This includes leading research projects, drafting protocols and statistical analysis plans, and disseminating scientific findings through various channels. The role involves close collaboration with internal and external stakeholders to inform decisions with real-world data and evidence.

Responsibilities

• Identify research study needs, draft proposals and protocols, and contribute to RWE strategy and study conduct across the therapeutic area portfolio.
• Work closely with Epidemiology colleagues to define research questions, develop epidemiological protocols, conduct analyses, and interpret and communicate evidence.
• Participate in multi-disciplinary matrix teams to address issues where RWD/RWE can inform decisions.
• Provide epidemiological and/or statistical consulting and support to compound/product teams, and disseminate technical information through reports, presentations, and publications.
• Work within and outside of existing electronic databases to assess RWD feasibility, research natural history of diseases, perform statistical risk assessments, and use historical data to contextualize potential safety issues.
• Design and conduct post-authorization safety activities, including rapid analytics for signal strengthening and formal evaluation studies, as part of Pharmacovigilance and Risk Management Plans.
• 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 across functions utilizing RWE as part of the Integrated Evidence Generation Plan.
• Keep up to date with changes in the external environment, including advocating 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 the methods 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 at conferences, 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
• Advanced Analytics
• Clinical Operations
• Data Privacy Standards
• Developing Others
• Disease Management
• Emergency Planning
• Environmental Health
• Financial Competence
• Inclusive Leadership
• Industry Analysis
• Leadership
• Performance Measurement
• Public Health
• Public Health Surveillance
• Resource Planning
• Stakeholder Engagement
• Vendor Management
• Epidemiology

Skills

* Required skills

Benefits