Scientific Director, NAMs

Critical Path Institute (C-Path)•Remote, OR

1d•$122 - $183

About The Position

Critical Path Institute is seeking a Scientific Director, New Approach Methodologies (NAMs), to provide scientific leadership and technical support to the Executive Director of NAMs across a diverse portfolio of initiatives. Housed within C-Path’s Innovation in Translational Science and Biomarkers Program (iTSB), this role advances the development, evaluation, validation, regulatory acceptance, and Fit-For-Purpose application of NAMs to improve drug development and safety assessment. The role supports the NAMs portfolio, including the NAMs Developer Coalition (NAMs-DC) and its workstreams, the National Center to Accelerate Cures (NCAC), collaborations with external organizations, and consulting and advisory engagements. These engagements may involve aligning NAM use with regulatory needs, drafting regulatory documents, coordinating data, and supporting submissions. The Scientific Director also contributes to new partnerships, projects, and strategic opportunities as the portfolio evolves. The successful candidate brings expertise in NAMs and translational research, sound regulatory judgment, strong scientific writing skills, practical drug-development experience, and experience coordinating multidisciplinary projects. The role requires critically evaluating emerging technologies, translating complex evidence into actionable development and regulatory strategies, and collaborating with the Executive Director, project teams, technology developers, regulators, and external partners. The position has no supervisory responsibilities and requires occasional out-of-town travel, approximately 15–20%.

Requirements

PhD, PharmD, MD, or equivalent doctoral degree in a relevant scientific or clinical discipline.
3–5 years of experience in NAMs, nonclinical or translational research, toxicology, drug development, regulatory science, technology evaluation, method validation, FDA/EMA engagement, and/or related research.
Demonstrated knowledge of new approach methodologies and their potential applications in nonclinical safety assessment, translational research, and drug discovery and development.
Strong understanding of drug development and the scientific challenges and decision contexts in which NAMs may provide fit-for-purpose evidence.
Experience with one or more NAM approaches, such as micro physiological systems, organoids, advanced in vitro models, computational toxicology, in silico modeling, or related technologies, and ability to evaluate approaches beyond one’s primary specialization.
Understanding of NAM method characterization, verification, validation, reproducibility, biological relevance, performance standards, contexts of use, and evidence-generation strategies.
Working knowledge of FDA and EMA regulatory science expectations and evolving approaches to acceptance, qualification, or use of NAMs in regulatory decision-making.
Experience with strategic initiatives and project leadership.
Experience engaging with regulators or preparing scientific and regulatory submissions in medical product development.
Experience working in pharmaceutical, biotechnology, NAM technology development, contract research, academic, regulatory, nonprofit, or public/private partnership environments.
Demonstrated ability to work collaboratively, think strategically, and use an inclusive and consultative approach to problem solving and decision making.
Ability to communicate scientific evidence, technology assessments, validation strategies, and regulatory approaches to technical and nontechnical audiences, verbally and in writing.
Ability to author clear, concise, fit-for-purpose internal and external communications, scientific documents, regulatory documents, and technical reports.
Strong interpersonal skills to support teamwork and productive interactions among diverse personalities and areas of expertise.
Ability to garner support and coordinate resources in support of program and project objectives.
Ability to work independently and lead projects while working as part of a team and incorporating advice and feedback from colleagues, external experts, regulators, and consortium or program participants.
Ability to meet target deadlines and manage time effectively across multiple projects and disease areas.
Demonstrated aptitude for leading and managing complex teams and deliverables, including planning, identifying contingencies, course correcting, and evaluating project success.

Nice To Haves

Experience with NAMs applications in toxicology, safety assessment, pharmacology, disease modeling, or translational research.
Working knowledge of nonclinical study design, data quality, quantitative analysis, model performance evaluation, and scientific data interpretation.

Responsibilities

Assist the Executive Director of NAMs in providing scientific direction, technical review, and execution support across the NAMs portfolio and NAMs Developer Coalition workstreams.
Support NAMs-DC working groups and member activities, including scientific priorities, technology-specific development plans, evidence gaps, milestones, and deliverables.
Provide scientific support for the ARPA-H CATALYST project and participating teams, including technical assessment, regulatory science input, advisor engagement, and coordination of scientific deliverables.
Support NCAC initiatives, including development, scientific review, harmonization, regulatory science input on validation studies, and maintenance of a NAMs Glossary and related terminology or standards activities.
Contribute scientific expertise to collaborative initiatives.
Evaluate NAM technologies and proposed applications, including micro physiological systems, organ-on-chip platforms, in vitro models, computational and in silico approaches, and other emerging methods, considering biological relevance, reproducibility, robustness, limitations, and context of use.
Develop and review fit-for-purpose validation and evidence-generation strategies, study designs, performance criteria, data packages, and regulatory engagement plans to support NAM credibility and adoption.
Lead or contribute to scientific and regulatory writing for NAMs consulting engagements, including briefing packages, meeting materials, qualification or acceptance submissions, responses to agency feedback, reports, publications, and white papers.
Engage with FDA, EMA, and other regulatory stakeholders, industry scientists, NAM developers, academic researchers, validation organizations, and patient-focused partners to advance scientific alignment and regulatory readiness.
Collaborate with C-Path Regulatory Science, Data Collaboration Center (DCC), Quantitative Medicine, clinical and nonclinical science, and project management colleagues to align NAMs activities with drug development needs.
Author internal and external communications, regulatory documents, qualification documents, scientific publications, white papers, reports, and stakeholder updates.
Foster relationships with individuals among global regulatory bodies, industry partners, academic investigators, research-performing organizations, patient-focused organizations, diagnostics developers, and other collaborative efforts relevant to biomarker development.
Identify opportunities for cross-workstream coordination, common terminology, data sharing, method standardization, evidence reuse, and integration of NAMs across C-Path programs.
Support the development of new NAMs project concepts, consulting scopes, funding proposals, grants, partnership opportunities, and other strategic initiatives.
Provide scientific direction to project managers and working groups, as appropriate, to support implementation, coordination, tracking, and timely completion of scientific deliverables.
Travel occasionally for out-of-town meetings, approximately 15–20%.
Perform other duties and responsibilities as assigned.