Associate Director, Epidemiology

JOB DESCRIPTION

Associate Director, Epidemiology leads safety and regulatory epidemiology activities for products across multiple therapeutic areas and throughout all phases of lifecycle. This includes execution of post-marketing regulatory study research strategies, leading comprehensive epidemiologic feasibility assessments, development of epidemiologic study designs, overseeing study implementation, interpretation of findings and their communication to internal and external audiences.
Associate Director, Epidemiology is a subject matter expert in pharmacoepidemiologic methods, pharmacovigilance regulations, and specific therapeutic areas. Associate Director leads study execution teams for post-marketing regulatory studies, and supports the company global observation research efforts. Associate Director collaborates with Regulatory Affairs, Clinical Development, Biostatistics, Real World Evidence Center of Excellence, Global Medical Affairs, Health Economics and Outcomes Research and Clinical Operations.

GENERAL RESPONSIBILITIES AND REQUIRED SKILLS

• Major contributor and driver to the company safety risk management, signal detection, benefit/risk assessments, and post-marketing regulatory research strategies
• Expected to research the epidemiology of specific disease areas and events of interest, lead evaluation of data sources and data collection approaches, apply subject matter expertise in the design of observational studies, develop epidemiology sections for regulatory documents, and lead the post-marketing regulatory research strategy implementation

KEY RESPONSIBILITIES

• Effectively communicates safety and regulatory epidemiologic strategy to product teams
• Leads all stages of the design and implementation of regulatory post-marketing studies: from feasibility assessments, development of study designs and protocols, and execution of studies, to communication and dissemination of their results to internal and external (e.g., Regulatory Agencies, scientific communities) stakeholders
• Contributes to company publications strategy via development of conference abstracts, presentations, peer-reviewed manuscripts based on the findings of epidemiological studies
• Leads the development of epidemiology sections for Risk Management Plans (EU RMP, REMS, etc.) and other regulatory filings (NDA, PSUR, etc.) for products throughout lifecycle
• Leads systematic and targeted epidemiologic literature reviews to support safety evaluation and / or post-marketing research strategies
• Supports signal detection analyses of safety reporting system databases (FAERS, Vigibase) or other sources (e.g. Sentinel)
• Leads study execution teams for post-marketing regulatory studies
• Actively participates at strategic meetings including Disease Safety Teams, GMDA Sub-Teams, and Global Patient Safety staff meetings
• Collaborates cross-functionally to support company strategy for observational research, integrating innovative study methodologies
• May supervise interns and / or contractors

Minimum Qualifications

• PhD in epidemiology is required, pharmacoepidemiology training is preferred
• 5+ years' experience in pharmaceutical/biotechnology industry (preferred), CRO, or academic setting
• Solid knowledge of study design methodology in general medicine and clinical practice, evidenced by experience in designing/implementation of epidemiology studies
• Strong knowledge in pharmacovigilance guidelines and regulations; knowledge of international PV regulations is a plus
• Excellent verbal and written communication skills, including experience with scientific presentations and peer-reviewed publications, to translate epidemiologic research methods and results to diverse audiences
• Excellent independent decision-making skills
• Strong project management skills
• Proven ability to build strong collaborative relationships with stakeholders and business partners and to work effectively in a diverse matrix environment