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

About the Company

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 on attracting and retaining passionate and motivated employees who want to play a role in helping people with serious health conditions. Our highly entrepreneurial environment empowers employees and provides daily opportunities for professional development. 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.

Responsibilities

• Lead the development and execution of integrated evidence generation strategies aligned with Medical Affairs & Evidence Generation (including 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 (including HEOR), Clinical Development, Clinical Science, Biostatistics, Regulatory, Market Access, Commercial, and external experts to ensure alignment of evidence priorities and execution plans.
• Drive, develop, and maintain 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 data, and external stakeholder feedback into actionable evidence strategies and recommendations for senior leadership.
• Monitor emerging scientific literature, competitive intelligence, treatment landscape trends, and evolving payer/access requirements within immunology, allergy, inflammation, and related therapeutic areas.
• Ensure scientific rigor, operational excellence, and compliance with internal SOPs, FDA regulations, GCP guidelines, and applicable industry standards.
• Partner with Scientific Communications and Publications to support dissemination of evidence through congresses, manuscripts, presentations, and scientific exchange initiatives.
• Contribute to external scientific engagement activities including advisory boards, congresses, investigator interactions, and scientific collaborations.
• Manage external vendors, research partners, budgets, timelines, and operational execution as needed.
• Support development of evidence generation infrastructure, processes, metrics, and operational best practices within Medical Affairs.

Requirements

• Advanced scientific or healthcare degree required (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.
• Prior leadership experience within a matrixed pharmaceutical or biotechnology environment preferred.
• Immunology, allergy, inflammation, dermatology, or related therapeutic area experience required.
• Strong understanding of trial design, biostatistics, bioinformatics highly desirable.
• Experience supporting clinical-stage or commercial-stage products preferred.
• Experience interacting with investigators, academic institutions, cooperative groups, and external scientific collaborators preferred.
• Experience supporting global and US evidence generation initiatives preferred.
• 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.
• 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.

Schedule

Travel Required: 20%

Pay

The expected base salary for this position is $203,157 to $263,841. Compensation includes base salary, annual discretionary bonus, long-term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days.

Benefits

A summary of our benefits can be found on our careers page.