Senior Director, Clinical Science & Development

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

Job summary

Daiichi Sankyo, Inc. is seeking a Clinical Scientist Lead to drive development plans and protocol strategies for pivotal trials.

The role oversees clinical study design, regulatory submissions, and interactions with Health Authorities, serving as a scientific lead within Clinical Science and coordinating with Clinical Operations and BD&O team. The ideal candidate has 10+ years of clinical research experience, hematology exposure, and a proven record in late-phase studies; travel up to 20% is

Qualifications

• Bachelor's Degree in life sciences or related field required.
• 10+ years relevant clinical experience required.
• Hematology experience preferred.
• Experience leading large, late-phase (Phase 2/3 or Phase 3) clinical studies.
• Travel up to 20% of the time.

Responsibilities

• Leads drafting of development plans.
• Owns the development of study design to meet study objectives.
• Responsible for providing 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 the Integrated Data Review Plan process.
• In early-phase development, may lead clinical strategy development.
• Leads study team in authoring of protocol and responsible for ICF creation.
• Leads development of protocol deviation management plan and contributes to monitoring protocol compliance to ensure proper identification and categorization of protocol deviations.

Education

Bachelor's Degree life sciences or related field

Master's Degree, PharmD, PhD or equivalent preferred

Postgraduate training in TA or related specialty, or equivalent preferred

Job description

Daiichi Sankyo, Inc. is seeking a Clinical Scientist Lead to drive development plans and protocol strategies for pivotal trials.

The role oversees clinical study design, regulatory submissions, and interactions with Health Authorities, serving as a scientific lead within Clinical Science and coordinating with Clinical Operations and BD&O team. The ideal candidate has 10+ years of clinical research experience, hematology exposure, and a proven record in late-phase studies; travel up to 20% is