Foundation for the National Institutes of Health (FNIH)

Job DetailsJob Location: North Bethesda, MD 20852Position Type: Full TimeSalary Range: $185,000.00 - $225,000.00 Salary/yearThe 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 

QualificationsRequired 

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.