Senior Director, Immunology Epidemiology & RWE

Celldex Therapeutics, Inc.

Hampton (NJ)

On-site

USD 203,157 - 263,841

Full time

14 days+

Application generator

Turn this role into an interview — a resume and cover letter built around what this employer wants.

Get past ATS filters

Job summary

Celldex Therapeutics, Inc. is seeking a Senior Director of Epidemiology to lead epidemiology and real-world evidence strategies for its immunology portfolio, including barzolvolimab and future programs.

You will translate real-world data into actionable insights to inform clinical development, regulatory strategy, safety, and payer engagement. The role requires deep expertise in epidemiology, strong scientific judgment, and collaboration across Clinical Development, Biostatistics,

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.

Responsibilities

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.
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.
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.
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 Celldex’s growth.