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Director of Epidemiology (M/F/D)
Tasks:
To design and execute Epidemiology activities and studies adressing safety research questions in the context of drug development, regulatory submissions, and marketed products,
To identify epidemiological / pharmaco-epidemiological methods, relevant data sources, best suited to address safety research questions
To transfer epidemiologic expertise and deliverables to the evaluation, refinement and contextualization of safety findings and potential signals, evaluation of safety signals (including literature reviews), as well as to the preparation and update of Epidemiology content in safety and regulatory documents (including but not limited to Risk Minimization Plan, FDA/EMA Orphan Drug Designation)
To conduct the feasibility, design, preparation of study concepts, protocols, and statistical analysis plans, know-how transfer to analysis execution for the Epi analytical team, and report of pharmacoepidemiologic studies of assigned DS products in line with the strategic epidemiology plan
Evaluating the feasibility of establishing multiple indication cohorts for RWE generation using CPRD and other RWD sources
Qualification:
PhD in Epidemiology and/or pharmacoepidemiology or equivalent advantageous
At least 5-year experience in epidemiology/ pharmacoepidemiology as well as in drug safety
At least 3-year experience in CRO (pharmacoepidemiology) or pharmaceutical industry
Proven experience in executing pharmacoepidemiology studies using RWD, including CPRD
Experience in oncology epidemiology preferred
Excellent written and oral communication skills in English
Excellent personal and intercultural skills paired with the ability to work cross functionally in a multinational organization
Requirements:
Start: 1.5.25
Duration: 15 months
Capacity: 5 days per week
Location: Greater Munich area; 100% remote possible + travel