Senior Director Epidemiology

hace 7 meses

All, España Daiichi Sankyo Europe A tiempo completo

Passion for Innovation. Compassion for Patients.

With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.

In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.

Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.

For our headquarters in all Europe we are seeking highly qualified candidates to fill the position:

Senior Director Epidemiology (m/f/x)

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 

Why work with us?

Working at Daiichi Sankyo is more than just a job – it is your chance to make a difference and change patients’ lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.

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