Global Clinical Science Director

Daiichi Sankyo US; Basking Ridge (NJ); On-site; USD 202,000 - 303,000; Full time

Job summary

Daiichi Sankyo US is seeking a senior Clinical Scientist to lead development plans, protocol profiles, and regulatory sections for clinical submissions. The role oversees one or more trials, guiding strategy and expert direction across Clinical Science and Regulatory interactions.

You will collaborate with Translational Medicine, Clinical Pharmacology, and BD&O to shape biomarker strategies, data quality, and SDV plans, while coordinating with CROs/AROs for program success.

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.
• 10+ years relevant clinical experience required.
• Hematology experience preferred.
• Experience leading large, late-phase (Phase 2/3 or Phase 3) clinical studies.
• Advanced Technical Expertise: pre-clinical and clinical research, protocol writing, data review, study design, and disease area knowledge.

Responsibilities

• Leads drafting of development plans and study design objectives.
• Owns development of study design to meet study objectives and provides strategic direction to Biostatistics and Data Operations for EDC, SAP, and data quality listings.
• Develops biomarker/PK strategy in collaboration with TMCP; co-leads Integrated Data Review Plan with Data Management.
• Leads study team in authoring of protocol and responsible for ICF creation; oversees recruitment and trial execution.
• Leads interactions with internal experts and external KOLs; represents Clinical Science in IST/OPT and in CRO/ARO collaborations.

Education

Bachelor's Degree life sciences or related field

Master's Degree, PharmD, PhD or equivalent

Postgraduate training in TA or related specialty, or equivalent preferred

Job description

Daiichi Sankyo US is seeking a senior Clinical Scientist to lead development plans, protocol profiles, and regulatory sections for clinical submissions. The role oversees one or more trials, guiding strategy and expert direction across Clinical Science and Regulatory interactions.

You will collaborate with Translational Medicine, Clinical Pharmacology, and BD&O to shape biomarker strategies, data quality, and SDV plans, while coordinating with CROs/AROs for program success.