Senior Director, Immunology Clinical Development

Celldex Therapeutics, Inc.; New Haven (CT); On-site; USD 234,000 - 373,000; Full time

Job summary

Celldex Therapeutics, Inc. is seeking an Executive Director of Clinical Development to lead programs across allergy, dermatology, and related immunology areas.

You will shape development strategy, oversee trial execution from Phase 1 through 4, and manage safety data, publications, and KOL engagements. The role requires a strong background in immunology development, cross-functional leadership, and experience with regulatory submissions.

Qualifications

• MD with specialization in allergy/dermatology/immunology/pulmonary/GI.
• Minimum of 8 years of experience in clinical development at a biotech/pharma company.
• Experience in designing and monitoring Phases 2-3 clinical trials.
• Experience with regulatory submissions (INDs/NDAs) and data interpretation.

Responsibilities

• Oversee the clinical development of Phase 1-4 clinical trials.
• Collaborate with protocol development, regulatory documents, and trial materials (IND, BLA, NDA, annual reports).
• Ensure all development activities are timely and of high quality.
• Provide medical support to clinical operations, regulatory and preclinical programs.
• Medical monitoring with oversight of patient safety.
• Lead external collaborations with CROs, academic partners, and KOLs.
• Interpret trial data and prepare study reports, presentations, and publications.
• Develop scientifically aligned engagement and communication strategy for immunology assets.

Skills

Excellent communication

Interpersonal skills

Cross-functional teamwork

Organizational skills

Education

MD with allergy/dermatology/immunology/pulmonary/GI specialization

Tools

MS Word

Excel

PowerPoint

Job description

Celldex Therapeutics, Inc. is seeking an Executive Director of Clinical Development to lead programs across allergy, dermatology, and related immunology areas.

You will shape development strategy, oversee trial execution from Phase 1 through 4, and manage safety data, publications, and KOL engagements. The role requires a strong background in immunology development, cross-functional leadership, and experience with regulatory submissions.