Senior Director, Clinical Science & Development Strategy

Celldex; Hampton (NJ); On-site; USD 177,000 - 229,000; Full time

Job summary

Celldex seeks a Director of Clinical Science to lead strategic study design, data interpretation, and development strategies for innovative therapies. This role will coordinate with Clinical Operations, Biostatistics, Regulatory Affairs, and Medical Writing to translate scientific insights into robust clinical programs.

Responsibilities include protocol development, cross-functional leadership, and data-driven decision making across all development stages, with emphasis on high-quality study

Qualifications

• Advanced scientific degree and leadership in clinical science.
• 10+ years in clinical research/development within biotech/pharma.
• Experience leading Phase 1–3 study design and data review.

Responsibilities

• Lead design and development of protocols and study documents across all phases.
• Interpret and review efficacy, safety, biomarker, PK/PD data with teams.
• Provide scientific oversight during study conduct and governance meetings.
• Prepare regulatory submissions and interact with health authorities.

Skills

Clinical leadership

Study design

Data interpretation

Regulatory knowledge

Education

Advanced degree (PhD/MD/ PharmD, etc.)

Tools

GCP/ICH guidelines

Job description

Celldex seeks a Director of Clinical Science to lead strategic study design, data interpretation, and development strategies for innovative therapies. This role will coordinate with Clinical Operations, Biostatistics, Regulatory Affairs, and Medical Writing to translate scientific insights into robust clinical programs.

Responsibilities include protocol development, cross-functional leadership, and data-driven decision making across all development stages, with emphasis on high-quality study