Sr. Director, Medical Evidence Generation, Immunology - Hampton, NJ
$203,157–$263,841 year
On-siteHampton, New Jersey, United States
Job Summary
Develop and execute integrated evidence generation strategies for Celldex's immunology portfolio, identifying gaps to drive clinically meaningful data for late-stage development and launch. Lead oversight for post-marketing Ph3b/Ph4 studies, Investigator-Initiated Research, and real-world evidence initiatives while collaborating cross-functionally with Clinical Development, Regulatory, and Market Access teams. Drive the development and maintenance of integrated evidence plans across the product lifecycle, translating scientific insights into actionable recommendations for senior leadership. Monitor emerging literature, competitive trends, and payer requirements to ensure operational excellence and compliance with FDA regulations and GCP guidelines. Manage external vendors, budgets, and timelines while supporting dissemination of evidence through congresses and publications. Requires 10+ years of experience in Medical Affairs or clinical research within a matrixed biotech environment, with 5+ years in evidence generation and immunology expertise. 20% travel required.
Required Qualifications
- Advanced scientific or healthcare degree (PhD, PharmD, MD, MPH, MS, or equivalent)
- Minimum of 10+ years of pharmaceutical, biotechnology, clinical research, or Medical Affairs experience
- Minimum of 5+ years of experience supporting evidence generation, Medical Affairs research, HEOR, RWE, and/or integrated evidence planning initiatives
- Immunology, allergy, inflammation, dermatology, or related therapeutic area experience
Desired Qualifications
- Prior leadership experience within a matrixed pharmaceutical or biotechnology environment
- Strong understanding of trial design, biostatistics, bioinformatics
- Experience supporting clinical-stage or commercial-stage products
- Experience interacting with investigators, academic institutions, cooperative groups, and external scientific collaborators
- Experience supporting global and US evidence generation initiatives
- Strong expertise in evidence generation, Medical Affairs research, clinical research, with working understanding of HEOR/RWE/outcomes research within the pharmaceutical or biotechnology industry
- Deep understanding of integrated evidence planning and evidence generation strategies supporting clinical and commercial objectives
- Strong scientific and clinical acumen with the ability to interpret and communicate complex clinical and scientific data
- Experience supporting or leading Medical Affairs Sponsored Studies (MAST), investigator-sponsored research (ISR), collaborative studies, and/or real-world evidence initiatives
- Strong understanding of clinical trial design, epidemiology, evidence methodologies, and scientific data interpretation
- Proven ability to lead complex cross-functional initiatives within a matrixed organization
- Strong strategic thinking, project leadership, and organizational skills
- Excellent written, verbal, presentation, and interpersonal communication skills
- Ability to build credibility and collaborative relationships with internal stakeholders, investigators, academic partners, and key opinion leaders
- Experience managing external vendors, budgets, timelines, and operational execution
- Ability to thrive in a fast-paced, collaborative biotechnology environment
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