Senior Director, Epidemiology in Basking Ridge, NJ at DSI

Date Posted: 3/18/2020

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Job Description

Join a Legacy of Innovation 110 Years and Counting!
With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.

Job Summary:
Position leads Epidemiology activities &/or projects in support of new drug development &/or post-marketing drug safety for the marketed products. The epidemiologist is responsible for the design, conduct, analysis, & reporting of pharmacoepidemiologic research studies of assigned DSI products, for providing consultation on epidemiologic issues as needed, & lead the strategic plan for epidemiologic studies. This position provides epidemiologic expertise & deliverables for RMP/REMS, evaluation of safety signals, feasibility of Epidemiologic studies &/or safety surveillance, & advice for future studies in line with the product strategic plan. In collaboration with development team &/or clinical safety team, this position provides feedback in the clinical trial design, safety analysis plan, & propose more complex data analysis. This position also independently manages relationships with internal and external key stakeholders to conduct Epidemiologic studies & may provide recommendations to lower levels. This position solves complex technical problems and partnership/clientele issues related to epidemiologic studies with advanced experience and expertise. Finally, this position approves epidemiologic complex decisions for project teams & makes strategic decisions that impact more than one project team.

Integration of Epidemiology into developmental process & post-marketing safety. The epidemiologist leads major project area, particularly designs & coordinates all aspects of epidemiologic research programs according to DS strategy & propose new study design &/or statistical analysis as needed. Prepares reports to communicate epidemiologic study results to DSI management, internal committees, external investigators, & regulatory agencies. Collaborates with other groups at DSI in preparing documentation for regulatory agencies, reimbursement agencies or other organizations. Maintains awareness of new methods, tools & data sources to ensure that projects represent current state of science, & maintains professional knowledge by reading scientific journals, attending internal & external courses, & undertaking methodological research. Contributes to the scientific literature in the form of manuscripts & publications. Presents at professional scientific meetings, teaches courses, collaborates with external investigators, & communicates with scientific personnel at regulatory agencies.

RMP/REMS: Primarily responsible for drafting the related sections &/or supporting documents independently. Reviews the documents within epidemiology & safety, & across functions. The epidemiologist directs risk management activities to ensure high quality & is able to respond regulatory queries &/or inspections. The epidemiologist leads the assessment, interpretation & communication of relevant scientific literature; summarizes epidemiologic data; determines own approach to tasks & independently applies basic & more complex techniques; recognizes when additional statistical & programming consultation is needed & communicates requirements effectively; maintains awareness of internal & external data resources & identifies appropriate studies for addressing questions of interest, recognizing the limitations & strengths of various design options; provides consultation to other groups on the validity of observational studies, independently performs data queries & summarizes epidemiologic information in a tabular & graphical form and communicates impactful research to support the development of RMP/REMS of DS products.

Epidemiologic studies &/or safety surveillance program: Leads the study design including generation of study proposals. Drafts/reviews the study concept/protocols particularly the study design &/or statistical analysis plan. Leads the execution of pharmacoepidemiologic studies & projects (e.g. observational studies, registries, etc.) including the supervision of ordering & shipping of all equipment & supplies for observational studies when needed; directs design & preparation of data collection forms & data tabulations; drafts data summaries/reports of epidemiologic studies for regulatory submissions; drafts/reviews publications and technical reports with delegation of certain tasks when possible.

Evaluation of safety signals: Triage of concerns including safety concerns, & proactively engages with team members. Makes recommendations for identification, assessment or management of safety signals. Conducts evaluation of safety signal independently. Reviews & presents the results.

Provides support to clinical team on clinical trial design & SAP, and other functions: Proactively works with other groups to identify epidemiologic research needs for projects, works interactively to develop research studies to address such needs, & propose new study designs or effective ways of working. The epidemiologist develops & validates new measurement techniques, including but not limited to new instruments for measurement of health-related quality of life; critiques internally & externally written manuscripts/published literature &, provides epidemiologic consultation on clinical trial design, SAP, & interpretation.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

PhD degree in Pharmacoepidemiology (ScD or PhD), or PhD degree in Epidemiology, or MPH with experience in pharmaceutical
Required M.D. degree
At least ten years’ experience in epidemiology with at least 5 years in industry, or
At least 8 years of experience in drug safety
Experience in oncology epidemiology is a plus
Experience with direct reports is a plus

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.