Position: Epidemiology - Cardiovascular, Director #2092
Location: Southern, NY
Compensation: Based upon Experience
The Director will assume lead role in Epidemiology activities in support of marketed and development compounds of cardiovascular therapeutic area (TA). He/she will be accountable for pharmacoepidemiology strategy, leading cross-functional project teams and epidemiology activities such as regulatory agency-required epidemiologic studies and generation of epidemiology data to support clinical development and regulatory filings and approval, 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 pharmacoepidemiology strategy and conduct of regulatory-agency required epidemiologic studies such as PASS, PAES, PMR, DUS, effectiveness of REMS and RMMs in support of clinical development, regulatory filings, and post-marketing requirements
As a subject matter expert, contribute to other pharmacoepidemiology 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 functions, provide timely epidemiological and risk management support to project and product teams of TAs including design, implementation and data 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 other 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 Study Teams (including with external partners), The Company’s Safety Oversight Committee, and Independent Data Monitoring Committees
Proactively lead non-compound specific pharmacoepidemiology activities (ex. literature review and database queries in support of regulatory filling)
Provide inputs to IIS studies and other epidemiologic consultation on epidemiologic studies to other departments such as The Company’s Genetic Center
Actively participate in the development and maintenance of relevant SOPs and Working Instructions
Up-to-date knowledge of US, EU, 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 pharmacoepidemiologic activities
Significant experience working with external vendors.
Doctoral degree in epidemiology, generally with 5+ years of post-doctoral experience, including 3+ years of industry/regulatory experience.
MD, plus other post-graduate degree in epidemiology (ex. MPH, MSc), generally with 8+ years of experience including 5+ years of industry/regulatory experience.
Demonstrated achievements of increasing complexity/ responsibility.