Director, Epidemiology (Non-MD)
Company: Daiichi Sankyo
Location: Basking Ridge
Posted on: May 14, 2022
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Job Description:
Join a Legacy of Innovation 110 Years and Counting! Daiichi
Sankyo Group is dedicated to the creation and supply of innovative
pharmaceutical therapies to improve standards of care and address
diversified, unmet medical needs of people globally by leveraging
our world-class science and technology. With more than 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 cardiovascular diseases, under the Group's 2025
Vision to become a "Global Pharma Innovator with Competitive
Advantage in Oncology," Daiichi Sankyo is primarily focused on
providing novel therapies in oncology, as well as other research
areas centered around rare diseases and immune disorders. Job
Summary: Position 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 DSI products and
for providing consultation on epidemiologic issues, as needed. This
position provides epidemiologic expertise and deliverables for
RMP/REMS, evaluation of safety signals, feasibility of
Epidemiologic studies and/or safety surveillance. In collaboration
with development team and/or clinical safety team, this position
provides feedback in the clinical trial design, and safety analysis
plan . This position also independently manages relationships with
internal and external key stakeholders to conduct Epidemiologic
studies and 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 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 major
project area, particularly designs and coordinates all aspects of
epidemiologic research programs according to DS strategy. Prepares
reports to communicate epidemiologic study results to DSI
management, internal committees, external investigators, and
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 and data sources to ensure that projects represent
current state of science, and maintains professional knowledge by
reading scientific journals, attending internal and external
courses, and undertaking methodological research. Contributes to
the scientific literature in the form of manuscripts and
publications. Presents at professional scientific meetings, teaches
courses, collaborates with external investigators, and communicates
with scientific personnel at regulatory agencies. Participates in
training new department members and/or mentoring fellows. RMP/REMS:
Primarily responsible for drafting the related sections and/or
supporting documents independently. Reviews the documents. The
epidemiologist directs risk management activities to ensure high
quality. The epidemiologist leads the assessment, interpretation
and communication of relevant scientific literature; summarizes
epidemiologic data; determines own approach to tasks and
independently applies basic and more complex techniques; recognizes
when additional statistical and programming consultation is needed
and communicates requirements effectively; maintains awareness of
internal and external data resources and identifies appropriate
studies for addressing questions of interest, recognizing the
limitations and strengths of various design options; provides
consultation to other groups on the validity of observational
studies, independently performs data queries and summarizes
epidemiologic information in a tabular and graphical form and
communicates impactful research to support the development of
RMP/REMS of DS products. Epidemiologic studies and/or safety
surveillance program: Leads the study design including generation
of study proposals. Drafts/reviews the study concept/protocols
particularly the study design. Leads the execution of
pharmacoepidemiologic studies and projects (e.g. observational
studies, registries, etc) including the supervision of ordering and
shipping of all equipment and supplies for observational studies
when needed; directs design and preparation of data collection
forms and 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. Study feasibility: Independently evaluates external
databases and/or other data sources including registries for study
feasibility. Prepares the study feasibility reports. Reviews the
study feasibility reports. Evaluation of safety signals: Triage of
concerns including safety concerns, and proactively engages with
team members. Makes recommendations for identification, assessment
or management of safety signals. Conducts evaluation of safety
signal independently. Reviews and presents the results. Provides
support to clinical team on clinical trial design and SAP, and
other functions: Proactively works with other groups to identify
epidemiologic research needs for projects, and works interactively
to develop research studies to address such needs. The
epidemiologist develops and validates new measurement techniques,
including but not limited to new instruments for measurement of
health-related quality of life; critiques internally and externally
written manuscripts/published literature and, provides
epidemiologic consultation on clinical trial design, SAP, and
interpretation. Qualifications: Successful candidates will be able
to meet the qualifications below with or without a reasonable
accommodation. Education/Experience: PhD (ScD or DrPH) degree in
Epidemiology, or MPH preferred 4 or More Years of experience in
drug safety preferred 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. 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.
Keywords: Daiichi Sankyo, Newark , Director, Epidemiology (Non-MD), Executive , Basking Ridge, New Jersey
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