Associate Director/Director, Non Clinical Toxicology – Cell & Gene Therapy

Associate Director/Director, Non Clinical Toxicology – Cell & Gene Therapy

• Lead nonclinical safety and toxicology activities across multiple programs from discovery and preclinical development through clinical development, regulatory approval, and commercialization.
• Establish and implement phase-appropriate nonclinical development and safety strategies, including study plans, timelines, milestones, budgets, and resource requirements.
• Provide scientific and strategic leadership for toxicology, GLP and non-GLP studies, safety pharmacology, and other nonclinical safety assessments.
• Lead and/or oversee IND-enabling toxicology programs, including study design, protocol development, CRO selection and oversight, data interpretation, and final study reports.
• Partner closely with Regulatory Affairs, Clinical Development, CMC, Research, and other functions to ensure nonclinical activities support overall development and filing strategies.
• Manage relationships with external CROs and other development partners, ensuring studies are appropriately designed, executed, and delivered according to program timelines and quality standards.
• Provide toxicology and nonclinical safety expertise during interactions with FDA, EMA, and other global health authorities.
• Author, review, and contribute substantially to nonclinical sections of regulatory submissions, including IND and BLA applications, as well as international regulatory filings and amendments.
• Prepare and/or oversee responses to regulatory questions related to nonclinical safety, toxicology, pharmacology, and study interpretation.
• Evaluate and integrate nonclinical data to identify potential safety risks and provide clear recommendations to project teams and senior management.
• Ensure high-quality nonclinical reports, regulatory documents, and supporting materials are delivered on schedule.
• Represent Nonclinical Safety/Toxicology on cross-functional program teams and provide subject matter expertise to internal and external stakeholders.
• Communicate complex scientific and regulatory concepts effectively through written reports, presentations, and discussions with technical and executive audiences.

Requirements:

• PhD with 8+ years of relevant industry experience, or M.S. with 12+ years, or B.S. with 15+ years of relevant experience in toxicology, pathology, pharmacology, or a related discipline.
• Demonstrated industry experience in cell and gene therapy, with experience in one or more of the following: gene therapy, cell therapy, viral vectors, AAV, LNPs, or other advanced therapeutic modalities.
• Strong experience designing and overseeing IND-enabling nonclinical safety programs.
• Demonstrated experience contributing to or leading IND submissions, including authorship of nonclinical safety/toxicology sections.
• Experience supporting BLA submissions and preparation or review of nonclinical content within regulatory applications is strongly preferred.
• Proven experience with regulatory writing and preparation of nonclinical sections for US and international regulatory submissions.
• Experience interacting with FDA, EMA/EMEA, and/or other global regulatory agencies and responding to health authority questions.
• Comprehensive knowledge of nonclinical drug development, including toxicology, safety pharmacology, GLP requirements, and regulatory expectations.
• Strong understanding of global regulatory requirements governing nonclinical development of advanced therapies.
• Demonstrated ability to develop and execute toxicology strategies while managing multiple programs and competing priorities.
• Significant experience selecting, managing, and collaborating with CROs, including protocol development, study oversight, data review, and final reporting.
• Excellent written and verbal communication skills, including the ability to develop and deliver clear scientific and regulatory presentations.
• Proven ability to operate effectively in a cross-functional, collaborative environment and influence program decisions through strong scientific judgment.

Preferred Experience:

• Experience taking a cell or gene therapy program from preclinical development through IND and/or BLA submission.
• Experience with LNP-based therapeutics, AAV, viral vectors, or other novel delivery platforms.
• Experience with multiple regulatory markets and global development programs.
• Prior experience serving as the nonclinical safety/toxicology lead for a development program.