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.
Key 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
Required
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
Preferred
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
This is a hybrid position and requires regular visits to FNIH headquarters in Bethesda, MD. This position may also require occasional travel for meetings, conferences and any other relevant engagements.
At FNIH we are committed to living our core values every day. If you are excited about this role and the work of the Foundation, but your experience doesn't align perfectly with all the qualifications in the job description, we encourage you to apply nonetheless. You may be just the right candidate for this or other roles at FNIH.
Compensation details: 00 Yearly Salary
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