Strategic Leader, Immunology Clinical Development

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

Job summary

Celldex in New Haven, CT is seeking an Executive Director, Clinical Development to lead immunology programs across allergy, dermatology and related areas. You will shape development strategy, oversee Phase 1-4 trials, ensure patient safety, and drive scientific content for regulatory submissions and publications.

Lead cross-functional teams, collaborate with CROs and KOLs, interpret trial data, and present findings at conferences.

Qualifications

• MD with allergy/dermatology/immunology/pulmonary/GI specialization preferred.
• 8+ years of clinical development experience at biotech/pharma.
• Experience designing and monitoring Phases 2-3 trials.
• Biologics or small-molecule immunology focus in allergies/immunology preferred.
• Experience with regulatory submissions (NDA/IND) preferred.
• Strong data interpretation and presentation skills.
• Effective cross-functional collaboration and communication.

Responsibilities

• Oversee planning, execution, and monitoring of Phase 1-4 trials.
• Develop clinical trial protocols and regulatory documents.
• Ensure high-quality, timely activities across programs.
• Provide medical support to operations and regulatory programs.
• Medical monitoring with oversight of patient safety.
• Lead data interpretation and prepare study reports/publications.
• Engage with CROs, KOLs, and academic partners to advance programs.

Skills

Leadership

Cross-functional

Regulatory knowledge

Communication skills

Education

MD degree

Tools

MS Word

Excel

PowerPoint

Job description

Celldex in New Haven, CT is seeking an Executive Director, Clinical Development to lead immunology programs across allergy, dermatology and related areas. You will shape development strategy, oversee Phase 1-4 trials, ensure patient safety, and drive scientific content for regulatory submissions and publications.

Lead cross-functional teams, collaborate with CROs and KOLs, interpret trial data, and present findings at conferences.