Clinical Science Associate Director: Study Design & Strategy

Daiichi Sankyo Co.; Basking Ridge (NJ); On-site; USD 180,000 - 230,000; Full time

Job summary

Daiichi Sankyo, Inc. seeks an Associate Director, Clinical Science to lead development plans and protocol-level activities, providing scientific direction across Clinical Operations and related functions.

The role involves overseeing a clinical trial, collaborating with Translational Medicine, Clinical Pharmacology, and BD&O, and contributing to regulatory submissions and data interpretation for study success.

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.

Responsibilities

• Drafts development plans, protocol profiles, protocols, and informed consent forms.
• Oversees a clinical trial and prepares clinical sections of regulatory documents.
• Provides scientific direction to Clinical Operations and other functions.
• Leads input on study design to meet objectives and SDV planning.
• Advects biomarker/PK strategy with TMCP and data management input.
• Leads development of protocol deviation management and monitoring of protocol compliance.
• Reviews inclusion/exclusion criteria and study design elements for consistency.
• Oversees recruitment/retention and contingency planning for shortfalls.
• Collaborates with CRO/ARO for study team meetings and budget input.

Skills

Clinical trial design

Data review

Regulatory drafting

Cross-functional collaboration

Education

Bachelor's Degree life sciences

Master's Degree or PharmD or PhD

Postgraduate TA or related training

Job description

Daiichi Sankyo, Inc. seeks an Associate Director, Clinical Science to lead development plans and protocol-level activities, providing scientific direction across Clinical Operations and related functions.

The role involves overseeing a clinical trial, collaborating with Translational Medicine, Clinical Pharmacology, and BD&O, and contributing to regulatory submissions and data interpretation for study success.