Executive Director of Toxicology

Legend Biotech is seeking Executive Director of Toxicology as part of the Clinical Development team based in Philadelphia, PA or Somerset, NJ. 

Role Overview

We are seeking a highly experienced and strategic Senior Director of Toxicology to lead and oversee all nonclinical safety assessment activities for our cell and gene therapy programs. This individual will play a pivotal role in guiding toxicology strategy from early research through IND-enabling studies and into clinical development, ensuring regulatory compliance and scientific rigor in support of our pipeline of advanced therapies.

This is a senior leadership position that requires deep expertise in toxicology as applied to CGT modalities (e.g., AAV, lentiviral, gene editing, cell-based therapeutics), a strong understanding of regulatory requirements, and the ability to work cross-functionally in a fast-paced biotech environment

Key Responsibilities  

• Lead and oversee all toxicology strategy and execution for preclinical development programs in cell and gene therapy.


• Design, implement, and interpret nonclinical safety studies, including IND-enabling toxicology, biodistribution, and pharmacokinetics.


• Provide scientific and strategic input to project teams across discovery, preclinical, regulatory, and clinical functions.


• Manage non-GLP and GLP-compliant studies conducted at CROs; review protocols, monitor studies, and interpret data.


• Serve as the primary toxicology subject matter expert for interactions with regulatory agencies (FDA, EMA, etc.); support or lead preparation of regulatory submissions (e.g., pre-IND, IND, BLA).


• Contribute to risk assessment of new and ongoing programs, including off-target effects, immunogenicity, insertional mutagenesis, and long-term safety.


• Participate in the development of target product profiles and preclinical safety packages to support clinical development and commercial strategy.


• Collaborate closely with internal functions such as Pharmacology, CMC, Regulatory Affairs, Clinical, and Program Management.


• Maintain up-to-date knowledge of evolving regulatory guidelines and scientific advances in CGT toxicology.


• Has authority and should have the ability to make decisions on preclinical toxicology strategies and execution plan

Requirements

• Ph.D., DVM, or equivalent in Toxicology, Pharmacology, or related field. DABT certification preferred. Immunology training is desired


• Minimum 10–15 years of experience in biotech/pharmaceutical R&D with at least 5 years in overseeing toxicology for advanced therapies


• Extensive experience with nonclinical safety assessment of gene and cell therapies, including knowledge of viral vectors, gene editing, and immunological considerations.


• Proven track record of contributing to successful IND/CTA and BLA/NDA filings.


• Strong understanding of FDA, EMA, and ICH regulations pertaining to toxicology and CGT development.


• Experience working with CROs and managing GLP-compliant study execution.


• Demonstrated leadership, communication, and organizational skills.


• Ability to translate complex scientific findings into clear, actionable recommendations for cross-functional stakeholders.

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