Sr. Director, Epidemiology, Immunology - Hampton, NJ

About Celldex

Celldex is pioneering new horizons in immunology to deliver life-changing therapies. We are relentless in our pursuit of novel antibody-based treatments that engage the human immune system and directly affect critical pathways to improve the lives of patients with allergic, inflammatory and autoimmune disorders. We have built a culture where innovative and talented people thrive—focusing a significant effort on attracting and retaining passionate and motivated employees who want to play a role in helping people with serious health conditions and who see this effort as personally rewarding.

In our highly entrepreneurial environment, employees are empowered and the opportunity for professional development occurs every day.

The Senior Director, Epidemiology, Immunology will be responsible for developing and executing epidemiology and real-world evidence strategies to support Celldex’s immunology portfolio, including barzolvolimab and future pipeline programs. This individual will generate evidence to inform clinical development, regulatory strategy, safety, Medical Affairs, payer/HTA engagement, and commercialization readiness.

This role requires deep epidemiology expertise, strong scientific judgment, and the ability to translate real-world data into meaningful insights that support decision-making across the product lifecycle. The Director will work closely with Clinical Development, Biostatistics, Pharmacovigilance, Regulatory Affairs, Medical Affairs, HEOR, Commercial, and external partners to design and deliver high-quality epidemiologic research in a fast-moving, entrepreneurial environment.

Epidemiology & Real-World Evidence Strategies

• Develop and execute epidemiology and real-world evidence strategies aligned to clinical development, regulatory, safety, Medical Affairs, and commercialization objectives.
• Serve as the epidemiology lead for assigned immunology programs and indications.
• Generate evidence related to disease burden, natural history, unmet need, treatment patterns, patient populations, epidemiologic trends, and real-world outcomes.
• Support evidence generation for chronic spontaneous urticaria, other mast cell-driven diseases, and future allergic, inflammatory, and autoimmune indications.
• Identify fit-for-purpose real-world data sources, including claims, electronic health records, registries, chart review, and other relevant data assets.

Study Design & Execution

• Lead the design and execution of post-marketing requirement studies, retrospective database analyses, literature reviews, chart reviews, registries, and external comparator or natural history studies, and support observational studies and other prioritized data generation initiatives.
• Develop and review study concepts, protocols, statistical analysis plans, study reports, abstracts, manuscripts, and presentations.
• Partner with Biostatistics, Data Management, Clinical Development, and external vendors to ensure scientific rigor, methodological quality, and timely delivery.

• Ensure studies are conducted in accordance with applicable standards, internal processes, privacy requirements, and regulatory expectations.

Cross-Functional Partnership

• Support the Medical Affairs and Evidence Generation Team with evidence generation to inform scientific communication, publication strategy, payer engagement, and value demonstration.
• Partner with Clinical Development to inform trial design, endpoint strategy, feasibility, patient population characterization, and external comparator approaches.
• Partner with Clinical Development and Regulatory Affairs to support BLA and sBLA submissions, FDA information requests, and PMR negotiations.
• Collaborate with Pharmacovigilance to support safety signal evaluation,…