Dir, Epidemiology

Dir, Epidemiology ( Job Number: 121050 ) Description The incumbent is Fully Developed in the role, works independently; Leadership position

- Owns the development and execution of the Epidemiology Strategic Plans for the products/projects in the Neurology
- Participates in external regulatory meetings, as needed
- Takes initiative/may provide leadership into the development of Epi business processes, as required
- Oversight of therapeutic area/product group budget planning and tracking
- Mentors less experienced co-workers
- Line management, as needed

Key Duties and Responsibilities:

- Development Support: Owns, develops and executes on the epi strategic plan for assigned products/projects within the therapeutic area (TA). Staffs clinical development subteams, post-approval teams, publication teams and safety management teams for the TA. Designs and executes observational studies (Phase I-IV, as needed); Supervises systematic reviews of the medical literature; Provides epidemiologic input into development strategic plans and submissions Authors/Reviews publications/makes presentations regarding disease state awareness (e.g. scientific manuscripts, abstracts, posters, internal and external presentations); May participate in/present at external stakeholder meetings, e.g. advisory boards; Actively participates in preparation for advisory committee/device panel meetings or other regulatory meetings, as needed; Participates in external regulatory meetings, as needed. Responsible for maintaining the Epi strat plan, disease epi module and pharmacoepi module.
- Global Safety Support: Provides strategic input, initiative/leadership, and epidemiologic and program evaluation input into risk management plans (RMPs, REMS and QRMP); Strategic and operational oversight on epidemiological commitments in RMPs/REMS (e.g. patient and prescriber surveys, drug utilization studies, registries, etc.); Determines epidemiologic strategy, provides input and review into Periodic Safety Update Reports and safety evaluations in response to ad-hoc safety-related queries for assigned products as needed Staffs safety management teams for the TA. Responsible for maintaining the Epi strat plan, disease epi module and pharmacoepi module.
- Commercial Support: Staffs post-approval and publication teams for the TA. Provide epi input and data to support post-approval scientific business needs via the epi strategic plan. Responsible for maintaining the Epi strat plan, disease epi module and pharmacoepi module.
- Epi leadership: Takes initiative/may provide leadership into the development of RME business processes, as required; Oversight of therapeutic area/product group budget planning and tracking; Mentors less experienced co-workers; Line management, as needed.