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. 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.
Overview:
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.
Responsibilities:
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 initiativesContribute 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 initiativesContribute 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
Qualifications:- 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 preferredExperience interacting with investigators, academic institutions, cooperative groups, and external scientific collaborators preferredExperience 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
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
Travel Required: 20%Compensation Statement
The expected base salary for this position is: $203157.00 to $263841.00. We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market. Subject to eligibility and applicable plan terms, 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. A summary of our benefits can be found on our careers page Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.
Job Summary:
