Senior Director Epidemiology

Senior Director Epidemiology

Daiichi Sankyo Europe

Munich, Germany

Purpose of the Function

The Senior Director Epidemiology leads Epidemiology activities and/or projects in support of new drug development and/or post-marketing drug safety for the marketed products. The epidemiologist is responsible for the design, conduct, analysis, and reporting of pharmacoepidemiologic research studies of assigned DS products, for providing consultation on epidemiologic issues as needed, and lead the strategic plan for epidemiologic studies. This position provides epidemiologic expertise and deliverables for RMP, evaluation of safety signals, feasibility of Epidemiologic studies and/or safety surveillance, and advice for future studies in line with the product strategic plan. Finally, this position approves epidemiologic complex decisions for project teams and makes strategic decisions that impact more than one project team.

Responsibilities

• Integration of Epidemiology into developmental process and post-marketing safety: The epidemiologist leads a major project area, particularly designs and coordinates all aspects of epidemiologic research programs according to DS strategy and propose new study design and/or statistical analysis as needed. Prepares reports to communicate epidemiologic study results to DS management, internal committees, external investigators, and regulatory agencies.
• RMP: Primarily responsible for drafting the related sections and/or supporting documents independently. Reviews the documents within epidemiology and safety, and across functions.
• Literature: Leads the assessment, interpretation and communication of relevant scientific literature reviews; summarizes epidemiologic data; summarizes epidemiologic information and communicates appropriately to the requester. Contributes to the scientific literature in the form of manuscripts and publications and presents them at professional scientific meetings.
• Epidemiologic studies and/or safety surveillance program: Leads the study design including generation of study concept sheets and protocols and reviews other study documents e.g. statistic analysis plans. Leads the execution of pharmacoepidemiologic studies and projects (e.g. PASS, other observational studies, registries, etc.) including study team set-up and collaboration with other functions within DS.
• Study feasibility: Independently evaluates external databases and/or other data sources including registries for study feasibility. Prepares the study feasibility reports.
• Evaluation of safety signals using EVDAS or other databases: Triage of concerns including safety concerns, and proactively engages with team members. Makes recommendations for identification, assessment or management of safety signals.
• Proactively works with other groups to identify epidemiologic research needs for projects, works interactively to develop research studies to address such needs, and propose new study designs or effective ways of working.

Experience Qualifications

• PhD in Epidemiology and or pharmacoepidemiology
• At least 7 years of experience in epidemiology/ pharmacoepidemiology as well as in drug safety
• 4 or More Years in pharmaceutical industry
• SAS skills preferred
• Experience in oncology epidemiology preferred
• Experience in leading and developing a team
• 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
• Experience of working in global environment in interdisciplinary teams

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