Senior Clinical Science Lead: Study Strategy & Execution

Daiichi Sankyo; Basking Ridge (NJ); On-site; USD 150,000 - 190,000; Full time

Job summary

Daiichi Sankyo in the United States is seeking an Associate Director, Clinical Science to lead development planning, trial oversight, and regulatory submissions under the supervision of the Clinical Science Asset Lead. The role focuses on scientific direction across study design, data review, and collaborative execution with CROs and internal teams.

You will partner with Translational Medicine, Clinical Pharmacology, Biostatistics, and Data Management to drive biomarker strategies, ED C plans,

Qualifications

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

Responsibilities

• Drafts development plans, protocols, and sections of submission documents.
• Oversees a clinical trial and provides scientific direction to Clinical Operations.
• Develops biomarker/PK strategy in collaboration with TMCP.
• Leads study team in authoring protocol and ICF creation.
• Consults and recruits DSMB/adjudication committee and develops charters.
• Ensures protocol deviations are managed and monitored.

Skills

Clinical trial design

Data review

Cross-functional collaboration

Regulatory document support

Education

Bachelor's Degree life sciences or related field

Master's Degree, PharmD, or PhD or equivalent preferred

Postgraduate training in TA or related specialty, or equivalent, preferred

Job description

Daiichi Sankyo in the United States is seeking an Associate Director, Clinical Science to lead development planning, trial oversight, and regulatory submissions under the supervision of the Clinical Science Asset Lead. The role focuses on scientific direction across study design, data review, and collaborative execution with CROs and internal teams.

You will partner with Translational Medicine, Clinical Pharmacology, Biostatistics, and Data Management to drive biomarker strategies, ED C plans,