Senior Clinical Science Lead — Trials & Strategy

Daiichi Sankyo; Basking Ridge (NJ); On-site; USD 162,000 - 244,000; Full time

Job summary

Daiichi Sankyo, Inc. is seeking a Clinical Science professional to draft development plans, protocols, and ICFs, and to oversee a clinical trial under supervision. You will provide scientific direction to Clinical Operations and collaborate with CROs/AROs to ensure trial success.

The role emphasizes study design, regulatory submissions, and cross-functional teamwork, with travel up to 20% for global activities.

Qualifications

• Bachelor's Degree in life sciences or related field is required.
• Advanced degree (PhD/ PharmD/ Master) preferred.
• Postgraduate training in TA or related specialty preferred.
• 4+ years clinical experience with PharmD/PhD or 7+ years with Master’s degree.

Responsibilities

• Draft development plans, protocols, and ICF sections.
• Oversee a clinical trial and provide study-level guidance.
• Collaborate with TMCP, BD&Os, and Clinical Operations on SDV, SAP, and data quality.
• Lead protocol design discussions and manage risk and contingencies.
• Support regulatory submissions and health authority responses.

Skills

Clinical research

Protocol writing

Study design

Regulatory submissions

KOL collaboration

Education

Bachelor's Degree life sciences

Master's Degree, PharmD, or PhD

Postgraduate TA training

Tools

EDC

SAP

Data management tools

Job description

Daiichi Sankyo, Inc. is seeking a Clinical Science professional to draft development plans, protocols, and ICFs, and to oversee a clinical trial under supervision. You will provide scientific direction to Clinical Operations and collaborate with CROs/AROs to ensure trial success.

The role emphasizes study design, regulatory submissions, and cross-functional teamwork, with travel up to 20% for global activities.