Daiichi Sankyo US · 1 week ago
Manager, Clinical Science
Basking Ridge, NJ
Full-time
Onsite
Mid Level
$125K/yr - $187K/yr
3+ years expDaiichi Sankyo is dedicated to improving lives through innovative medicines and has a strong presence in the global healthcare market. The Manager of Clinical Science will draft development plans and protocols, perform data cleaning, and collaborate with various teams to ensure the successful execution of clinical studies.
Health CareTherapeuticsWellness
Responsibilities
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
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
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
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
Performs literature review related to new indications for Life Cycle Management
Qualification
Required
Bachelor's degree in life sciences or related field required
3 or more years of relevant clinical experience with Bachelor's degree
Technical Proficiency: Develop and demonstrate proficiency in necessary technical skills and tools
Preferred
Master's degree, PharmD, PhD or equivalent preferred
Postgraduate training in TA or related specialty, or equivalent preferred
1-3 years of relevant clinical experience with advanced degree (PharmD, PhD) preferred
Be adept at preparing documentation and supporting materials for various clinical trial activities preferred
Company
Daiichi Sankyo US
Daiichi Sankyo US is a pharmaceutical company delivering innovative research, solutions, and treatments to improve health.
10001+ employees
H1B Sponsorship
Daiichi Sankyo US has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (32)
2024 (25)
2023 (19)
2022 (12)
2021 (7)
2020 (6)
Funding
Current Stage
Late StageLeadership Team
Ken Keller
Chairman of the Board, President and CEO and Head of the Global Oncology Business Unit
Christopher Geloso
Senior Region Business Director - ADC Oncology at Daiichi Sankyo, Inc.
Recent News
2025-06-01
2025-02-18
Company data provided by crunchbase