The Director, Epidemiology is responsible for the development, coordination and execution of epidemiology/ pharmaco-epidemiology research for product support at a global level, from early development through life-cycle management.
Ensures oversight of strategic epidemiology plans for all products
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Provides strategic input into post-approval commitments / requirements and risk evaluation and mitigation strategies
Provides strategic epidemiologic input into development strategic plans and submissions
Provides subject matter expertise, guidance and direction to internal and external stakeholders
Ensure oversight of observational studies ( Phase I-IV) to describe and quantify disease epidemiology and real-world usage, patient exposure, safety and effectiveness
Ensures optimal management of cross-functional projects, identifies potential risks to project objectives, ensure scientific integrity and cost-effective project delivery
Participates on advisory committee / device panel meeting preparation teams or other regulatory agency meetings, as needed
Develops and maintains excellent relationships with both internal and external stakeholders, qualified vendors/consultants
Maintains up-to-date knowledge of industry best practices in epidemiology and risk management, recognized as internal expert and go-to person
Manages direct report(s)
Main Areas of Responsibilities
Develops and owns product epidemiology strategy for drug development, pharmacovigilance and commercial purposes across product lifecycle. 25%
Ensure oversight of observational studies ( Phase 1-IV) including study design and execution. 25%
Perform critical appraisal and synthesis of relevant epidemiological literature, including to support exploration of new disease areas. 15%
Provides pharmacovigilance support including risk management plans as well as PASS development and delivery, PBRERs, PSURs and regulatory responses. 15%
Provides epidemiologic input into corporate plans ( global development, commercial, medical, franchise) and regulatory submissions 15%
Maintain awareness of regulatory requirements, initiatives and advances in pharmacoepidemiology 5%
Requirements
PhD in epidemiology, MD or PharmD with a Master’s degree in epidemiology, Master degree’s in epidemiology with relevant experience as an epidemiologist
at least 5 years’ experience ( 10 years would be an asset) in a pharmaceutical company or a CRO with excellent knowledge of pharmacoepidemiology, pharmacovigilance, Risk Management and REMS
Excellent methodological and analytic skills
Excellent communication and presentation skills
Good organization and project management skills
Good interpersonal skills ( i.e. team player)
Ability to adjust to changing priorities
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