Director, Nonclinical Toxicology - Cell & Gene Therapy

Commonwealth Sciences, Inc.; Boston (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Commonwealth Sciences, Inc. is seeking an Associate Director/Director of Non Clinical Toxicology in Cell & Gene Therapy to lead nonclinical safety across programs from discovery to regulatory filings.

You will establish phase-appropriate strategies, manage CROs, interact with regulators, and contribute to IND/BLA submissions. The candidate should have a PhD with extensive experience in toxicology and cell/gene therapy, plus strong leadership and cross-functional collaboration skills to guide

Qualifications

• PhD with 8+ years of relevant industry experience, or MS with 12+ years, or B.S. with 15+ years of relevant experience in toxicology, pathology, pharmacology, or a related discipline.
• 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.

Responsibilities

• Lead nonclinical safety and toxicology activities across multiple programs from discovery through commercialization.
• Establish and implement phase-appropriate development and safety strategies including plans, timelines, budgets, and resources.
• Provide scientific and strategic leadership for toxicology, GLP and non-GLP studies, safety pharmacology, and other nonclinical safety assessments.
• Lead IND-enabling toxicology programs, including design, CRO oversight, data interpretation, and final reports.
• Partner with Regulatory Affairs, Clinical Development, CMC, Research, and other functions to align nonclinical activities with development plans.
• Manage external CRO relationships and ensure studies meet timelines and quality standards.
• Provide toxicology expertise during FDA/EMA interactions and regulatory submissions.
• Prepare and contribute to nonclinical sections of IND and BLA regulatory submissions and amendments.
• Prepare responses to regulatory questions related to nonclinical safety and pharmacology.
• Evaluate nonclinical data to identify safety risks and advise project teams.
• Ensure high-quality nonclinical reports and supporting materials are delivered on schedule.
• Represent Nonclinical Safety on cross-functional program teams and communicate complex concepts effectively.

Skills

IND-enabling studies

Regulatory writing

Cross-functional leadership

Regulatory interactions

Toxicology strategy

Executive communication

Education

PhD in toxicology or related field

MS in toxicology

BS in toxicology or related field

Job description

Commonwealth Sciences, Inc. is seeking an Associate Director/Director of Non Clinical Toxicology in Cell & Gene Therapy to lead nonclinical safety across programs from discovery to regulatory filings.

You will establish phase-appropriate strategies, manage CROs, interact with regulators, and contribute to IND/BLA submissions. The candidate should have a PhD with extensive experience in toxicology and cell/gene therapy, plus strong leadership and cross-functional collaboration skills to guide