Program Manager or Director, Cancer Vaccine Development

This role is based at the FNIH offices in North Bethesda, MD, reporting to the Senior Vice President of Translational Science within the Science Partnerships department. The position is hybrid, requiring regular visits to headquarters and occasional travel for meetings, conferences, and other engagements.

About the Role

The Foundation for the National Institute of Health (FNIH) seeks a Program Manager or Director to lead a groundbreaking national initiative accelerating the development and clinical application of next-generation cancer vaccines. This public-private collaboration aims to deliver clinical proof-of-concept in high-risk, minimal residual disease (MRD+) cancers while building a sustainable ecosystem for antigen discovery, vaccine development, manufacturing, and data-driven innovation.

As a scientifically credible and operationally adept leader, you will unify efforts among partners across academia, biopharma, government, philanthropy, advocacy, and individuals with lived experiences. You will serve as the central facilitator for partnership development, vaccine candidate selection, adaptive clinical trial design, research coordination, and funding strategy.

Responsibilities

• Lead the scientific and operational partnership strategy for the Cancer Vaccines Initiative and related projects.
• Facilitate identification and prioritization of impactful use cases, including rapid demonstration trials in MRD+ cancer settings.
• Ensure alignment among teams focused on antigen discovery, preclinical development, vaccine platforms, manufacturing, and clinical execution.
• Lead collaborative processes to prioritize candidate antigens, vaccine constructs, and combination strategies.
• Establish criteria for advancement, down-selection, and evolution of the portfolio.
• Represent the initiative in scientific, clinical, and policy discussions; contribute to publications, presentations, and strategic communications.

Clinical Trial Strategy & Execution

• Oversee the design and execution of adaptive clinical trials focused on early efficacy signals and immune responses.
• Ensure rigorous trial design and execution across multiple locations.
• Integrate biomarkers and immune monitoring into trial design and analysis.
• Promote speed, quality, and comparability across trials.

Manufacturing & Immune Monitoring Infrastructure

• Ensure the development of scalable GMP manufacturing techniques across platforms.
• Standardize immune monitoring assays and endpoints across studies.

Data & AI-Enabled Innovation

• Collaborate with data science leaders to develop and utilize a centralized data architecture supporting the initiative.
• Facilitate integration of clinical, immunologic, and molecular data for antigen prediction and vaccine design.
• Support AI-driven approaches for optimized candidate selection and trial learning.

Regulatory Strategy & Engagement

• Work with regulatory agencies to align innovative trial designs, endpoints, and biomarker strategies.
• Design programs to support future regulatory pathways and potential approvals.
• Assist in regulatory submissions and advice interactions where necessary.

Partnership Development & Engagement

• Lead interactions with biopharmaceutical companies, academic researchers, technology partners, philanthropists, advocacy groups, and individuals with lived experiences.
• Build a collaborative ecosystem aligned around shared scientific and translational goals, leveraging philanthropy and governmental support.
• Work with Strategic Alliances and Advancement teams to secure funding for initiative goals.
• Communicate the value and impact of the initiative to diverse funding bodies.

Program Governance & Execution

• Establish and lead governance structures, including executive and steering committees and scientific advisory groups.
• Coordinate timelines, milestones, budgets, and deliverables across all program components.
• Ensure transparency, accountability, and effective decision-making throughout all partnerships and relevant organizations.

Requirements

• MD, PhD, or equivalent in oncology, immunology, or a related biomedical field.
• Program Manager candidates: approximately 7+ years of relevant experience in oncology drug development, cancer immunotherapy, or vaccine development.
• Director-level candidates: 10+ years of progressively responsible experience in these domains.
• Strong understanding of translational science across discovery, preclinical, and clinical phases, with a focus on clinical trial design and execution, particularly in multi-site studies.
• Proven capability to lead complex, multi-institutional public-private partnerships.

Preferred Qualifications

• Experience interacting with regulatory agencies (e.g., FDA, EMA).
• Background in 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.
• Demonstrated success in high-impact team leadership.

Pay

$150,000 - $225,000 yearly salary.