Position: Epidemiology Director Job #2091
Location: Central NJ or Westchester, NY
Compensation: Based Upon Experience
The Director will be accountable for epidemiology strategy and pharmacoepi projects for assigned marketed and/ or development compounds as the therapeutic lead, leading epidemiology activities and cross-functional project teams to support clinical development and regulatory required non-interventional studies, and providing consultation as an in-house subject matter expert in epidemiology to other departments.
Duties & Responsibilities:
With oversight from Head of Pharmacoepidemiology:
Responsible for pharmacoepi strategy and conduct of post-authorization studies for assigned therapeutic areas (TAs) as the TA lead
As a subject matter expert, contribute to other pharmacoepi activities, including but not limited to: (Development) Risk Management Plans; Benefit-Risk analyses; post-approval regulatory agency-required studies; signal management; responses to regulatory agency queries; regulatory filings
Working closely with Regulatory Affairs, Risk Management Leads and other interested parties, provide timely epidemiological and risk management support to project and product teams of TAs including design, implementation and analysis of epidemiological studies, review of study proposal from internal and external sources, and database activities such as exploring external electronic, patient-level database(s) (administrative claims/EMR/surveys/registries etc) to evaluate safety/benefit questions, mortality and morbidities/comorbidities, and appropriate epidemiologic data in support of clinical development and regulatory filings
Represent Pharmacoepidemiology on cross-functional teams, including Risk Management Task Force (RMTF), Safety Monitoring Teams (SMT), Clinical Development Teams (including with external partners), the Company’s Safety Oversight Committee, and Independent Data Monitoring Committees
Proactively lead non-compound specific pharmacoepidemiology activities (ex. descriptive non-interventional studies in support of regulatory filling of orphan drug application and/or pediatric investigation plan)
Provide inputs to IIS studies and other epidemiologic consulting service to other departments
Actively participate in the development and maintenance of relevant SOPs and Working Instructions
Actively participate in process improvement activities within Regulatory Affairs & Pharmacovigilance
Doctoral degree in epidemiology, generally with 5+ years of post-doctoral experience, including 3+ years of industry/regulatory experience.
Demonstrated achievements of increasing complexity/ responsibility.
Up-to-date knowledge of US and international regulatory and pharmacovigilance requirements and ability to apply this knowledge to activities for clinical trial and post-marketing environments.
Function as a subject matter expert on epidemiology for assigned compounds
Experience utilizing automated healthcare databases (internal and large external databases) to support pharmacoepi activities
Significant experience working with external vendors.