Associate Director, Clinical Science Employer Daiichi Sankyo Location Basking Ridge - NJ Start date Aug 21, 2026 View more categories View less categories Discipline Clinical , Clinical Research Required Education Bachelors Degree Position Type Full time Hotbed Pharm Country , Best Places to Work Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Send job

Job Details Company Job Details Job Description Job Title:

Associate Director, Clinical Science Job Requisition ID:

1851

Posting Start Date:

7/21/26 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 supervision of Clinical Science Asset Lead or Clinical Science Lead, drafts development plans, protocol profiles, protocols, informed consent forms, and sections of submission documents. Oversees a clinical trial. Prepares clinical section of regulatory document. Represents Clinical Science on Project Team and collaborates as team member with other functions, AROs/CROs. Provides scientific direction to Clinical Operations and other functions. This position requires minimal supervision to provide critical study-level support to the

CSL/PS/MM/GCL

for the successful execution of assigned studies.

Job Description Responsibilities Study Strategy:

Under supervision of Clinical Science Asset Lead or Clinical Science Lead, drafts development plans. Participates in the development of study design to meet study objectives by owning sections/components. Provides 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. Develops biomarker/PK strategy in collaboration with Translational Medicine and Clinical Pharmacology (TMCP). With Data Management, co-leads or provides input to the Integrated Data Review Plan process.

Study Planning and Execution:

Provides input on major milestones of trial, clinical trial plan and contingency planning. Analyzes and updates management on potential risks to study deliverables. Leads study team in authoring of protocol and responsible for ICF creation or provides input on ICF creation. Consults and recruits members for DSMB and/or adjudication committee setup and develops supporting documents and charters. Leads development of protocol deviation management plan and contributes to monitoring protocol compliance to ensure proper identification and categorization of protocol deviations. Reviews inclusion/exclusion criteria and other study design elements for consistency with study strategy. Oversees recruitment and retention; establishes and implements contingency plans for shortfalls.

Study outputs:

Reviews emerging clinical data regularly and shares data review findings with the study team. Performs quality assessment with Delivery Lead e.g. review Tables/Listings/Graphs before database lock and quality check of data; works with BD&O to ensure SAP update. Leads dose-escalation meetings and other site facing interactions with Clinical Operations. Collaborates with Translational Medicine and Clinical Pharmacology to ensure appropriate biomarker, PK / PD measurements. Draft clinical sections of regulatory documents and responses to IRBs and Health Authorities.

External collaboration:

Consults with internal experts and external KOLs, Ad Boards for protocol development. Provides input on

CRO / ARO

Statement of Work and Budget; represents Clinical Science in study team meetings with CRO and ARO Establishes effective communication between CRO / vendors / ARO.

Additional non-study related activities:

Occasional senior management interactions at

FIHC, WDC.

Initiates contact w/KOL and prepares material for KOL interactions to support study-based needs. Supports due diligence activities related to in-licensing and acquisitions. Qualifications Education Qualifications Bachelor's Degree life sciences or related field required PharmD or PhD preferred Postgraduate training in TA or related specialty, or equivalent, preferred Experience Qualifications 4 or more years with PharmD, PhD and relevant clinical experience or7 or more years with Bachelor's degree and relevant clinical experience preferred

Advanced Technical Expertise:

Possess advanced understanding of pre-clinical and clinical research, including protocol writing, data review, study design, and disease area knowledge. preferred Travel Requirements Ability to travel up to 30% of the time. In-house office position that may require travel (global). 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$162,400.00 - USD$243,600.00 Download Our Benefits Summary PDF Professionals Company 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. For more information, please visit: www.daiichisankyo.com . Daiichi Sankyo, Inc., headquartered in Basking Ridge, New Jersey, is a member of the Daiichi Sankyo Group. To learn more about Daiichi Sankyo, Inc., please visit www.dsi.com .

STOCK EXCHANGE

Tokyo Stock Exchange

STOCK SYMBOL

4568 Company info Website http://www.daiichisankyo.com/ Phone (908) 992-6400 Location 211 Mt. Airy Road Basking Ridge New Jersey 07920 United States Share this job Facebook Twitter LinkedIn Apply now Send job Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Get job alerts Create a job alert and receive personalized job recommendations straight to your inbox. Create alert Similar jobs Clinical Scientist Associate Director Early Development Inflammation Washington D.C., District of Columbia Senior Clinical Pharmacologist North Chicago, IL Scientific Director, Oncology Clinical Development South San Francisco, CA