Manager, Clinical Science
Company: Daiichi Sankyo
Location: Basking Ridge
Posted on: January 25, 2026
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Job Description:
Job Description Job Title: Manager, Clinical Science Job
Requisition ID: 775 Posting Start Date: 1/20/26 At Daiichi Sankyo,
we are united by a single purpose, to improve lives around the
world through innovative medicines. With a legacy of innovation
since 1899, a presence in more than 30 countries, and more than
19,000 employees, we are advancing breakthrough therapies in
oncology, cardiovascular disease, rare diseases, and immune
disorders. Guided by our 2030 vision to "be an innovative global
healthcare company contributing to the sustainable development of
society", we are shaping a healthier, more hopeful future for
patients, their families, and society. Job Summary Under guidance
of Clinical Science Lead (CSL) and/or Medical Monitor, drafts
development plans, protocol profiles, protocols, informed consent
forms, and clinical sections of submission documents. Performs
study level data cleaning of listings and patient profiles.
Represents Clinical Science on Study Team and collaborates as a
team member with other functions, AROs, and CROs. As part of the
clinical team, provides scientific input to Clinical Operations and
other functions. This position provides critical study-level
support to the CSL/PS/MM/GCL for the successful execution of
assigned studies. Responsibilities Study Strategy: Under guidance
of CSL and/or Medical Monitor, drafts development plan. Supports
CSL and/or Medical Monitor in development of study design to meet
study objectives. Contributes to provide strategic direction to
Biostatistics and Data Operations (BDO) for EDC, edit checks, data
quality listings, SAP, Data Mgmt plan and to Clinical Operations on
SDV plan. Participates in the development of biomarker/PK strategy
in collaboration with Translational Medicine and Clinical
Pharmacology (TMCP). Provides input to the Integrated Data Review
Plan process with Data Management. Performs literature review and
creates reference list for study. Study Planning and Execution:
Contributes to clinical trial planning including identification of
potential risks to study deliverables and contingency planning.
Supports development of protocol profile, protocol, and ICF
template. Participates in the selection of ARO, CRO, and members
for DSMB and/or adjudication committee and the development of
charters for study committees (e.g., Executive Committee). Provides
input to Clinical Operations on monitoring plan (e.g. data fields
to be SDV’d), to Data Management on the Integrated Data Review
Plan, and to Biostatistics on Statistical Analysis Plan (SAP).
Reviews patient demographics, enrollment, retention and protocol
compliance. Study outputs: Reviews emerging clinical data
regularly. Performs quality assessment of Tables/Listings/Graphs
before database lock; collaborates with lead statistician on SAP
update, as needed. Provides input to Clinical Operations on site
issues. Contributes to development of CSR. External collaboration:
Participates in discussions with internal experts and external KOLs
for protocol development. Participates in the review of CRO and ARO
Scope of Work and budget. Participate in study team meetings with
CRO and ARO. Contributes to establish effective communication with
CRO, ARO, and vendors. Additional non-study related activities:
Performs literature review related to new indications for Life
Cycle Management. Qualifications Education Qualifications
Bachelor's degree in life sciences or related field required
Master's degree, PharmD, PhD or equivalent preferred Postgraduate
training in TA or related specialty, or equivalent preferred
Experience Qualifications 1-3 years of relevant clinical experience
with advanced degree (PharmD, PhD) preferred 3 or more years of
relevant clinical experience with Bachelor’s degree Technical
Proficiency: Develop and demonstrate proficiency in necessary
technical skills and tools. Be adept at preparing documentation and
supporting materials for various clinical trial activities
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. Salary Range: USD$124,960.00 - USD$187,440.00
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Keywords: Daiichi Sankyo, Jersey City , Manager, Clinical Science, Science, Research & Development , Basking Ridge, New Jersey
