Sr. Director, Medical Evidence Generation, Immunology - Hampton, NJ

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.

As we prepare for potential commercialization, including our lead asset barzolvolimab
, we are building a world-class Medical Affairs organization to support late-stage development and launch. Our culture is entrepreneurial, fast-moving, and deeply mission-driven—where passionate individuals can make a meaningful impact.

The Senior Director, Medical Evidence Generation, Immunology will serve as a strategic leader within Medical Affairs & Evidence Generation responsible for the development and execution of integrated evidence generation strategies and plans (i.e., IEP) supporting Celldex’s immunology portfolio. This individual will partner cross-functionally within Medical Affairs & Evidence Generation (incl. HEOR), Clinical Development, Clinical Science, Biostatistics, Regulatory, Market Access, Commercial, and external scientific experts to identify evidence gaps and drive the generation of clinically meaningful, scientifically rigorous, and impactful evidence supporting Celldex programs across the product lifecycle.

This role will lead evidence generation strategies, provide strategic oversight, and co-lead initiatives including post-marketing Ph3b/Ph4 studies in collaboration with Clinical Sciences & Clinical Development, Investigator Initiated Research Studies (IIRs), collaborative research efforts, real-world evidence (RWE) initiatives, outcomes research, and integrated evidence planning activities. The individual will play a key role in shaping evidence strategies supporting late-stage development, launch readiness, lifecycle management, and future commercialization activities across Celldex’s immunology pipeline.

The ideal candidate will bring strong scientific and strategic expertise in evidence generation, clinical research, Medical Affairs, and RWE studies, along with the ability to operate effectively within a highly collaborative, matrixed biotechnology environment.

• Lead the development and execution of integrated evidence generation strategies aligned with Medical Affairs & Evidence Generation (incl. HEOR), clinical development, and commercialization objectives
• Identify key evidence gaps and develop strategic plans to generate clinical, real-world, health economics, and patient-centered evidence supporting Celldex products and pipeline programs
• Provide leadership and oversight for post-marketing Ph3b/Ph4 studies in collaboration with R&D, Investigator-Initiated Research studies (IIRs), collaborative research programs, and other evidence generation initiatives
• Partner cross-functionally with Medical Affairs & Evidence Generation (incl. HEOR), Clinical Development, Clinical Science, Biostatistics, Regulatory, Market Access, Commercial, and external experts to ensure alignment of evidence priorities and execution plans
• Drive, development and maintenance of integrated evidence plans (IEPs) across barzolvolimab and Celldex’s future immunology portfolio
• Collaborate with external investigators, academic institutions, cooperative groups, and key opinion leaders to advance strategic research initiatives
• Contribute scientific and strategic input into study concept development, protocol design, evidence prioritization, and data generation strategies
• Support evidence generation activities across the product lifecycle, including late-stage development, launch readiness, post-launch evidence needs, and lifecycle management
• Translate scientific insights, clinical…