Strategic Director, Clinical Science & Development

Celldex Therapeutics, Inc.; Hampton, Northern (VA, KY); Hybrid; USD 203,000 - 264,000; Full time

Job summary

Celldex Therapeutics, Inc. is seeking a Senior Director, Clinical Science to shape clinical development strategy and oversee study design across programs.

You will translate complex clinical data into actionable development plans and partner with Regulatory Affairs and Executive Leadership to drive regulatory submissions. In this role, you will lead cross-functional teams, influence dosing and endpoints, and guide translational and biomarker strategies to support lifecycle management and

Qualifications

• Advanced degree in scientific, healthcare, or related discipline.
• 15+ years of clinical research or clinical development experience in biotech/pharma.
• Significant experience leading Clinical Science activities across Ph1–Ph3.
• Proven ability to present recommendations to executives and governance bodies.

Responsibilities

• Provide strategic leadership for one or more clinical development programs, aligning with portfolio strategy.
• Drive integrated development strategies across multiple studies and indications, including lifecycle management.
• Serve as Clinical Science representative to governance committees and senior leadership teams.
• Influence decisions on indication prioritization, dose selection, endpoint development, and regulatory strategy.
• Partner with Clinical Science physicians, Operations, Data Management, Regulatory Affairs, and Leadership to define development pathways.
• Review and approve key study design decisions, protocols, amendments, and documents.

Skills

Clinical leadership

Strategic thinking

Regulatory strategy

Cross-functional collaboration

Education

Advanced degree (PhD/MD/DO/etc)

Job description

Celldex Therapeutics, Inc. is seeking a Senior Director, Clinical Science to shape clinical development strategy and oversee study design across programs.

You will translate complex clinical data into actionable development plans and partner with Regulatory Affairs and Executive Leadership to drive regulatory submissions. In this role, you will lead cross-functional teams, influence dosing and endpoints, and guide translational and biomarker strategies to support lifecycle management and