Full Job Description
Overview
The Senior Director, Epidemiology, Immunology will be responsible for developing and executing epidemiology and real-world evidence strategies to support Celldex27s 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.
Responsibilities
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, risk characterization, and benefit-risk assessments.
Contribute epidemiologic input to regulatory submissions, briefing documents, response packages, and health authority interactions as appropriate.
Translate complex epidemiologic findings into clear, actionable insights for cross-functional stakeholders and senior leaders.
Scientific Leadership & External Engagement
Stay current with evolving epidemiology methods, real-world evidence guidance, data sources, regulatory expectations, and payer/HTA requirements.
Represent Celldex in scientific forums, congresses, external collaborations, and professional networks as appropriate.
Author or contribute to peer-reviewed publications, abstracts, posters, and presentations.
Provide scientific oversight of external vendors, research partners, consultants, and data providers.
Help build scalable epidemiology capabilities, processes, and standards to support Celldex27s growth.
Qualifications
PhD, DrPH, ScD, MPH, or MS in Epidemiology, Pharmacoepidemiology, Public Health, Biostatistics, Outcomes Research, or related field required.
PhD/doctoral-level training preferred. MD desirable but not required.
8+ years of relevant experience in epidemiology, real-world evidence, pharmacoepidemiology, HEOR, or related functions within biotechnology, pharmaceutical, academic, CRO, or consulting environments.
Strong expertise in epidemiologic methods, observational study design, real-world data analysis, causal inference, and pharmacoepidemiology.
Experience with NDA/BLA submissions, health authority inquiries, and development/execution of post-marketing commitments/requirements is required.
Experience using real-world evidence to support clinical development, regulatory strategy, safety, Medical Affairs, HEOR, and/or commercialization.
Demonstrated experience working with healthcare claims, electronic health records, registries, chart review, and other real-world data sources.
Ability to design and execute high-quality epidemiologic studies, including protocols, SAPs, study reports, publications, and presentations.
Strong understanding of drug development and evidence generation across the product lifecycle.
Ability to operate effectively in a cross-functional, matrixed environment and influence without direct authority.
Excellent written and verbal communication skills, with the ability to translate complex scientific concepts for diverse audiences.
Strong project leadership skills with the ability to manage multiple priorities, vendors, timelines, and deliverables.
High degree of scientific rigor, attention to detail, sound judgment, and accountability.
Ability to thrive in a fast-paced, entrepreneurial biotechnology environment.
Travel Required 20%
Preferred Experience
Experience in immunology, allergy, dermatology, respiratory, inflammatory, autoimmune, or mast cell-driven diseases preferred.
Experience supporting late-stage development, regulatory submissions, launch readiness, and/or post-marketing evidence generation.
Experience developing external comparator, natural history, disease burden, or treatment pattern studies.
Familiarity with payer/HTA evidence needs and value demonstration.
Track record of peer-reviewed publications, congress presentations, or external scientific engagement.
Experience managing external vendors, data providers, or research collaborations.
Compensation StatementThe 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. Compensation for this role 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
