Associate Director, Clinical Science: Study Design & Regulatory

Daiichi Sankyo, Inc.; Washington (District of Columbia); On-site; USD 150,000 - 190,000; Full time

Job summary

Daiichi Sankyo, Inc. in Washington, DC is seeking an Associate Director, Clinical Science to provide critical study-level support and scientific direction across trials, protocol development, and regulatory submissions.

Under supervision of the Clinical Science Asset Lead, you will draft development plans, contribute to study design, and collaborate with Translational Medicine, Clinical Pharmacology, and Clinical Operations. Travel up to 20% may be required.

Qualifications

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

Responsibilities

• Draft development plans and protocol profiles under supervision.
• Develop study design components to meet study objectives.
• Provide strategic direction to BD&O and Clinical Operations for data-related plans.
• Collaborate with TMCP to develop biomarker/PK strategy.
• Lead input on ICF creation and protocol deviation management.

Education

Bachelor's degree life sciences or related field

Master's Degree, PharmD, PhD or equivalent

Postgraduate training in TA or related specialty

Job description

Daiichi Sankyo, Inc. in Washington, DC is seeking an Associate Director, Clinical Science to provide critical study-level support and scientific direction across trials, protocol development, and regulatory submissions.

Under supervision of the Clinical Science Asset Lead, you will draft development plans, contribute to study design, and collaborate with Translational Medicine, Clinical Pharmacology, and Clinical Operations. Travel up to 20% may be required.