Program Manager or Director, Cancer Vaccines

About the position The Foundation for the National Institute of Health (FNIH) is seeking a Program Manager or Director, with final level determined based on experience and leadership capabilities, to lead a high-profile, multi-sector national initiative to accelerate the development and clinical translation of next-generation cancer vaccines. This public–private partnership is designed to deliver near-term clinical proof-of-concept in high-risk, minimal residual disease (MRD+) cancers while building a scalable, long-term ecosystem for antigen discovery, vaccine development, manufacturing, and data-driven innovation. The Program Manager or Director will oversee a coordinated portfolio spanning rapid demonstration trials, parallel development of multiple antigen classes and vaccine platforms, scalable GMP manufacturing, harmonized immune monitoring, and a centralized data architecture enabling AI-driven antigen prediction. This position will report to the Senior Vice President of Translational Science within the Science Partnerships department (or their designated report) and is based at the FNIH offices located in North Bethesda, MD. This role requires a scientifically credible, operationally strong leader who can align partners across academia, biopharma, government, philanthropy, advocacy, and persons with live experience and translate complex science into coordinated execution. The Program Manager or Director will as a centralized facilitator for overall partnership development, vaccine candidate selection, adaptive clinical trial design and implementation, research project coordination, and funding strategy.

Responsibilities

• Scientific & Program Leadership & Portfolio Management Lead the overall scientific and operational partnership strategy for the Cancer Vaccines Initiative and eventually other projects
• Facilitate the definition and prioritization of high-impact use cases, including rapid “quick win” demonstration trials in MRD+ cancer settings
• Ensure alignment of the groups working on antigen discovery, preclinical development, vaccine platforms, manufacturing, and clinical design and execution
• Lead collaborative processes to identify and prioritize candidate antigens, vaccine constructs, and combination strategies
• Establish criteria for advancement, down-selection, and portfolio evolution
• Represent the initiative in scientific, clinical, and policy forums
• Contribute to publications, presentations, and strategic communications
• Clinical Trial Strategy & Execution Oversee design and execution of adaptive, efficient clinical trials focused on early signals of efficacy and immune response
• Ensure rigorous trial design, site selection, and execution across multiple institutions
• Integrate biomarkers and immune monitoring into trial design and analysis
• Drive speed, quality, and comparability across trials
• Manufacturing & Immune Monitoring Infrastructure Oversee development of scalable GMP manufacturing approaches across platforms
• Ensure harmonization of immune monitoring assays and endpoints across studies
• Data & AI-Enabled Innovation Partner with data science leadership to build and utilize centralized data architecture supporting the initiative
• Enable integration of clinical, immunologic, and molecular data to inform antigen prediction and vaccine design
• Support AI-driven approaches to optimize candidate selection and trial learning
• Regulatory Strategy & Engagement Collaborate with regulatory agencies to align innovative trial designs, endpoints, and biomarker strategies
• Ensure programs are designed to support future regulatory pathways and potential approval
• Help to facilitate regulatory submissions and advice interactions, as needed
• Partnership Development & Partner Engagement Lead engagement with biopharmaceutical companies, academic investigators, technology partners, philanthropists, advocacy groups, and persons with lived experience
• Build and sustain a collaborative ecosystem aligned around shared scientific and translational goals, including philanthropy and government
• Partner with Strategic Alliances and Advancement to secure and align funding to support initiative goals
• Articulate the value proposition and impact of the initiative to diverse funders
• Program Governance & Execution Establish and lead governance structures, including executive and steering committees and scientific advisory groups
• Oversee timelines, milestones, budgets, and deliverables across all program components
• Ensure transparency, accountability, and effective decision-making across all partners and any relevant external organizations

Requirements

• MD, PhD, or equivalent in oncology, immunology, or related biomedical field
• Program Manager candidates should have approximately 7+ years of relevant experience in oncology drug development, cancer immunotherapy, or vaccine development, while Director level candidates should have 10+ years of progressively responsible experience in these areas.
• Strong understanding of translational science across discovery, preclinical, and clinical domains, including clinical trial design and execution, including multi-site studies
• Proven ability to lead complex, multi-institutional or public–private partnerships

Nice-to-haves

• Experience interacting with regulatory agencies (e.g., FDA, EMA)
• Experience with cancer vaccines, immuno-oncology, or antigen discovery platforms
• Familiarity with GMP manufacturing and immune monitoring technologies
• Experience with adaptive trial designs and biomarker-driven development
• Track record of high-impact team leadership

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