Associate Director, Clinical Science

Daiichi Sankyo US; Basking Ridge (NJ); On-site; USD 162,400 - 243,600; Full time

Job summary

Daiichi Sankyo US is seeking an experienced Clinical Scientist to lead development plans and regulatory sections for pivotal studies. Under supervision, you will draft protocols, ICFs, and submissions, coordinating with the CSL/PS/MM/GCL and external partners.

The role requires strong study design, data review, biomarker strategy, and cross-functional collaboration with Biostatistics, Data Operations, Translational Medicine, and Clinical Pharmacology.

Qualifications

• 4+ years with PharmD, PhD, and relevant clinical experience, or 7+ years with a Bachelor's degree and relevant clinical experience.
• Advanced technical expertise in pre-clinical and clinical research, including protocol writing, data review, study design, and disease-area knowledge.

Responsibilities

• Drafts development plans and protocol components under supervision.
• Leads protocol development and ICF creation; drafts regulatory sections of submissions.
• Provides input on Sponsor strategy, risk management, and study deliverables.
• Reviews emerging clinical data and coordinates with CROs/AROs for regulatory readiness.

Skills

Clinical research

Protocol writing

Data review

Study design

Disease area knowledge

Education

Bachelor's Degree in life sciences

Master's Degree, PharmD, or PhD preferred

Postgraduate training in TA or related specialty

Job description

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 the supervision of the Clinical Science Asset Lead or Clinical Science Lead, the candidate drafts development plans, protocol profiles, protocols, informed consent forms, and sections of submission documents. The role oversees a clinical trial, prepares the clinical section of regulatory documents, and represents Clinical Science on the Project Team, collaborating with other functions, AROs, and CROs. The position requires minimal supervision to provide critical study-level support to the CSL/PS/MM/GCL for the successful execution of assigned studies.

Responsibilities

Study Strategy

• Drafts development plans under supervision of the Clinical Science Asset Lead or Lead.
• Participates in study design development to meet objectives by owning sections and components.
• Provides strategic direction to Biostatistics and Data Operations for EDC, edit checks, data quality listings, SAP, data management plan, and to Clinical Operations on SDV plan.
• Develops biomarker/PK strategy in collaboration with Translational Medicine and Clinical Pharmacology.
• Co‑leads or provides input to the Integrated Data Review Plan process with Data Management.

Study Planning And Execution

• Provides input on major milestones, clinical trial plan, and contingency planning.
• Analyzes and updates management on potential risks to study deliverables.
• Leads the study team in authoring the protocol and is responsible for ICF creation or provides input on ICF creation.
• Consults and recruits members for DSMB and/or adjudication committee setup, developing supporting documents and charters.
• Leads development of protocol deviation management plan and contributes to monitoring protocol compliance.
• 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 findings with the study team.
• Performs quality assessment with Delivery Lead, reviewing tables, listings, and graphs before database lock and checking quality 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.
• Drafts clinical sections of regulatory documents and responses to IRBs and Health Authorities.

External Collaboration

• Consults with internal experts and external KOLs and 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, and ARO.

Additional Non‑study Related Activities

• Occasional senior management interactions at FIHC, WDC.
• Initiates contact with KOLs and prepares material for KOL interactions to support study needs.
• Supports due diligence activities related to in‑licensing and acquisitions.

Qualifications

Education Qualifications

• Bachelor's Degree in life sciences or related field required.
• Master's Degree, PharmD, or PhD preferred.
• Postgraduate training in TA or related specialty, or equivalent, preferred.

Experience Qualifications

• 4+ years with PharmD, PhD, and relevant clinical experience, or 7+ years with a Bachelor's degree and relevant clinical experience.
• 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

In‑house office position that may require global travel.

EEO Statement

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