Senior Director, Clinical Science & Study Strategy

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

Job summary

Daiichi Sankyo, Inc. in New Jersey is seeking a senior Clinical Scientist to lead and oversee development plans, protocols, informed consent forms, and submission sections.

You will participate in study oversight and provide scientific direction to Clinical Operations, supporting CLS/PS/MM/GCL for successful study execution. This role requires strong expertise in protocol writing, data review, study design, and biomarker strategy, with 7+ years of relevant experience for Master's degree holders

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.
• Contribute to study design to meet objectives and own sections/components.
• Provide strategic direction to Biostatistics and Data Operations for EDC and SAP.
• Develop biomarker/PK strategy with TMCP and Clinical Pharmacology.
• Draft clinical sections of regulatory documents and responses to IRBs.

Skills

Protocol writing

Data review

Study design

Disease area knowledge

Leadership

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. in New Jersey is seeking a senior Clinical Scientist to lead and oversee development plans, protocols, informed consent forms, and submission sections.

You will participate in study oversight and provide scientific direction to Clinical Operations, supporting CLS/PS/MM/GCL for successful study execution. This role requires strong expertise in protocol writing, data review, study design, and biomarker strategy, with 7+ years of relevant experience for Master's degree holders