Foundation for the NIH

Program Manager or Director, Cancer Vaccines North Bethesda, MD 20852 Position Type: Full Time Salary Range: $150,000.00 - $225,000.00 Salary/year Description 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 PIff790938f7ff-2607

Senior Data Officer, AVP North Bethesda, MD 20852 Position Type: Full Time Salary Range: $190,000.00 - $240,000.00 Salary/year Description The Foundation for the National Institute of Health (FNIH) is seeking a Senior Data Officer (SDO), an executive role responsible for helping to establish and lead the organization's data strategy, governance, and infrastructure to ensure that data is a trusted, secure, and high-value asset across all programs and partnerships. The SDO will oversee scalable data systems that enable high-quality data integration, access, and reuse across a diverse portfolio of scientific partnerships and research initiatives. This includes assisting in the oversight of Data COUNTS, the organization's role in serving as the trusted broker for NIH's federated electronic health record (EHR) data platform. Working closely with scientific, technology, and partnership leaders, the SDO will ensure that data across the organization is standardized/harmonized, governed, secure, and accessible-enabling downstream use in research, clinical development, regulatory engagement, and public-private collaborations. 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. Key Responsibilities Enterprise Data Strategy Help define and lead the organization's enterprise data strategy aligned with mission, scientific priorities, and growth objectives Position data as a strategic asset to support research, partnerships, and organizational decision-making Establish long-term roadmaps for data infrastructure, interoperability, and scalability Develop and implement enterprise-wide data governance frameworks, including data standards, quality, access, and lifecycle management Ensure the FNIH owned data is in compliance with privacy, security, and regulatory requirements (e.g., HIPAA, GDPR, NIST 800-171 etc. where applicable) Data Architecture & Infrastructure for Current Use and AI Enablement Oversee design and implementation of modern data architecture, including cloud-based platforms, data lakes, and federated data systems as need for the FNIH research partnerships Ensure harmonized integration of heterogeneous data types (clinical, genomic, imaging, digital, etc.) through common data models and standards for FNIH partnerships, implementing the same standards across partnerships when relevant Establish infrastructure and governance to support responsible and scalable use of AI/ML across the organization Partner with scientific and analytics leaders to ensure data is AI-ready, high-quality, and fit for advanced modeling Ensure data systems and practices meet requirements for regulatory-grade data where applicable Support audit readiness and data traceability for research and regulatory use cases Partnership Data Strategy Enable secure, compliant, and efficient data sharing across public-private partnerships Develop frameworks for multi-party data collaboration, including federated and privacy-preserving approaches Build trust with external partners through strong data governance and transparency Work with the project teams to establish clear policies for data ownership, sharing, and use across internal and external stakeholders Provide executive oversight of real-world evidence and AI data initiatives lead by the FNIH Organizational Leadership Partner with IT, security, legal, and scientific leadership to align data strategy across the organization and its partnerships Drive a culture of data quality, accountability, and stewardship Serve as the organization's senior authority on data strategy and governance Communicate data strategy and progress to executive leadership, board members, and external stakeholders Represent the organization in external forums on data governance, interoperability, and infrastructure Required Advanced degree (PhD, MD, MS, or equivalent) in data science, computer science, information systems, or related field 15+ years of experience in data leadership roles, including enterprise data strategy, governance, and architecture Demonstrated experience building and scaling large, complex data platforms or ecosystems Deep expertise in data governance, data architecture, and regulatory compliance Experience working with complex, multi-institutional or regulated data environments Preferred Experience in biomedical research, healthcare, or life sciences Familiarity with real-world data sources (EHR, claims, registries) and common data models (e.g., OMOP) Experience enabling AI/ML at scale within an enterprise data environment Experience in public-private partnerships or multi-stakeholder collaborations 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 PI73e5-

Director, New Approach Methodologies North Bethesda, MD 20852 Position Type: Full Time Salary Range: $185,000.00 - $225,000.00 Salary/year Description The Foundation for the National Institute of Health (FNIH) is seeking a Director, New Approach Methodologies (NAMs) for toxicology and drug development, who will lead the strategy, development, and execution of multi-sector scientific partnerships to advance, validate, and qualify innovative alternative models for drug development and human safety toxicity testing. These efforts will be under the banner of the NAMs Validation and Qualification Network (VQN) that is currently being stood up as a pillar to the Complement Animal Research in Experimentation (Complement-ARIE) Consortium facilitated by the National Institutes of Health (NIH). The projects within the VQN will include all types of NAMs, including in silico approaches, in vitro (e.g. microphysiological systems (MPS), organoids, and advanced cell/tissue systems), in chemico, and ex vivo, and the goal will be to drive these NAMs to a state of readiness for acceptance by the appropriate regulatory body. This role sits at the intersection of translational science, regulatory science, and collaborative innovation. The Director will work closely with biopharmaceutical, chemical, agrichemical, and comestics companies, regulatory agencies, academic investigators, and patient-focused organizations to accelerate the adoption of scientifically robust, fit-for-purpose models that improve predictive safety assessment and drug development and reduce reliance on traditional animal testing. This position will report to the Senior Vice President of Translational Science within the Science Partnerships department and is based at the FNIH offices located in North Bethesda, MD. The ideal candidate brings deep expertise in preclinical drug development and toxicology, paired with the ability to lead complex, precompetitive collaborations, and design projects that will move toward regulatory acceptance. Key Responsibilities Scientific & Program Leadership & Portfolio Management Develop and lead a strategic portfolio of programs focused on NAMs for drug development and human safety/toxicity assessment Identify high-impact use cases where NAMs can be developed precompetitively for validation and qualification for regulatory agencies, including FDA, EMA, EPA, and others in the US and globally Facilitate group creation of scientific frameworks for model validation, context of use (COU) definition, and evidentiary standards Design, launch, and manage multi-partner collaborations across industry, academia, government, and nonprofits Build trusted relationships with biopharma, chemical, agrichemical, and cosmetics R&D leaders, regulatory scientists, and academic innovators Regulatory Science & Qualification Pathways Lead efforts to align validation strategies with regulatory expectations (e.g., FDA, EMA, PMDA, EPS, OECD, etc.) Translate emerging science into regulatory-ready, validated models for submission to the relevant qualification programs (e.g., iSTAND, ENTRÉE, OECD, etc.) Program Oversight & Delivery Ensure rigorous governance of all of the VQN and each precompetitive project developed Aid the VQN project leads on milestone tracking and financial stewardship Lead cross-functional workstreams including internal staff and external partners to address key needs in the NAMs validation and qualification space Field Building & Thought Leadership Represent the organization in scientific and policy forums and partner interactions Contribute to publications and consensus frameworks that advance the field Required PhD or equivalent in toxicology, pharmacology, biomedical sciences, or related field 10+ years of experience in biopharmaceutical R&D, regulatory science, or translational research Demonstrated expertise in preclinical drug development and safety assessment Experience with NAMs (e.g., in silico, in vitro, in chemico, ex vivo) Proven ability to lead complex, cross-institutional scientific collaborations Preferred Direct experience interacting with regulatory agencies or contributing to regulatory submissions, including either drug development or environmental regulation Experience with NAM validation and/or qualification for regulatory acceptance Familiarity with global regulatory frameworks and emerging NAM guidance Strong track record of scientific 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 PId1cee112d4c2-2606

Director, Mental Health North Bethesda, MD 20852 Position Type: Full Time Salary Range: $185,000.00 - $225,000.00 Salary/year Description The Foundation for the National Institutes of Health (FNIH) is looking for a Director, Mental Health for Translational Sciences to evaluate, establish, and manage large-scale, multi-sector public-private partnerships focused on transforming the understanding, diagnosis, and treatment of neuropsychiatric disorders and mental health. The Director will operate at the intersection of clinical research, translational science, and regulatory engagement-working with academic investigators, biopharmaceutical partners, technology collaborators, patient organizations, and regulatory agencies to generate high-quality, actionable evidence that advances precision psychiatry. This role will oversee the protocol development and execution of an ambitious program integrating clinical data, multi-omics, digital phenotyping, imaging, and patient-reported outcomes to identify biologically and clinically meaningful subtypes of major depressive disorder (MDD) and predictive biomarkers of treatment response. 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. Key Responsibilities Scientific Leadership & Strategy Convene and facilitate partners and cross sector experts to drive the collaborative scientific strategy for a longitudinal MDD program focused on deep phenotyping and biomarker discovery, overseeing partner governance, joint protocol development, coordinated site selection, and integrated operational execution. Ensure integration of multimodal data (clinical, biological, imaging, behavioral, and digital) into a coherent scientific approach Partnership Leadership & Governance Establish governance structures, scientific steering committees, and working groups to drive alignment and accountability Serve as a trusted scientific leader and convener across diverse stakeholders with differing incentives Regulatory Engagement Work with partners to develop and lead regulatory strategies in collaboration with agencies (e.g., FDA, EMA) Ensure study designs and biomarker approaches align with regulatory expectations for qualification and clinical use and contribute to regulatory submissions, qualification packages, and scientific advice interactions Program Oversight & Delivery Manage complex program timelines, budgets, deliverables, and ensure dissemination of results through publications, data platforms, and stakeholder communications Oversee data governance, data sharing frameworks, and compliance with ethical and privacy standards Field Building & External Representation Represent the program in scientific, clinical, and policy forums and engage funders and strategic partners to sustain and expand initiatives Contribute to shaping the emerging field of precision psychiatry and biomarker-driven mental health research Required MD, PhD, or equivalent in psychiatry, neuroscience, clinical research, or related discipline 10+ years of experience in translational clinical research, including leadership of complex, multi-site studies or clinical trials Strong track record in preclinical translational research, biomarker development, or longitudinal cohort studies Proven ability to lead large, multidisciplinary, cross-sector collaborations Demonstrated experience interacting with regulatory agencies and contributing to regulatory strategy or submissions Preferred Training in neuropsychiatric research and/or practice experience in psychiatry or related mental health field Experience in major depressive disorder or other neuropsychiatric disorders Expertise in one or more relevant domains (e.g., neuroimaging, genomics, digital health, computational psychiatry) Experience with public-private partnerships or precompetitive consortia Track record of high-impact publications and scientific 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 PIdeee71e5bb18-2604