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.