Senior Director, Immunology Medical Evidence Strategy

Celldex Therapeutics, Inc.; Hampton (NJ); On-site; USD 158,304 - 263,841; Full time

Job summary

Celldex Therapeutics, Inc. is seeking a Senior Director, Medical Evidence Generation, Immunology, to lead integrated evidence generation strategies across the immunology portfolio.

The role partners with Medical Affairs, Clinical Development, Regulatory, and Commercial teams to identify evidence gaps and drive clinically meaningful data generation. The ideal candidate has a PhD/MD/PharmD/MPH/MS or equivalent and 10+ years in pharma/biotech clinical research or Medical Affairs, with 5+ years in

Qualifications

• Advanced scientific or healthcare degree required.
• Minimum 10+ years in pharma/biotech clinical research or Medical Affairs.
• Minimum 5+ years supporting evidence generation and integrated planning.

Responsibilities

• Lead development and execution of integrated evidence generation strategies.
• Identify evidence gaps and develop plans for clinical, real-world, HEOR and outcomes data.
• Oversee post-marketing Ph3b/Ph4 studies and ISR/IIR collaborations.
• Collaborate cross-functionally to align evidence priorities and execution.
• Drive development and maintenance of Integrated Evidence Plans (IEPs) for barzolvolimab.
• Engage with external investigators and key opinion leaders.
• Translate data into actionable evidence strategies for senior leadership.
• Ensure regulatory compliance and scientific rigor.

Skills

Medical Affairs leadership

Evidence generation

Real-world evidence (RWE)

HEOR

Clinical research

Trial design

Biostatistics

Cross-functional collaboration

Strategic thinking

Communication skills

Education

PhD/MD/PharmD/MPH/MS or equivalent

Job description

Celldex Therapeutics, Inc. is seeking a Senior Director, Medical Evidence Generation, Immunology, to lead integrated evidence generation strategies across the immunology portfolio.

The role partners with Medical Affairs, Clinical Development, Regulatory, and Commercial teams to identify evidence gaps and drive clinically meaningful data generation. The ideal candidate has a PhD/MD/PharmD/MPH/MS or equivalent and 10+ years in pharma/biotech clinical research or Medical Affairs, with 5+ years in