Sr. Director of Toxicology

About Legend Biotech

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

Job Summary

Legend Biotech is seeking Sr. Director of Toxicology as part of the Clinical Development team based in Philadelphia, PA. 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.

Requirements

• Maintain up-to-date knowledge of emerging toxicology trends and regulatory guidelines.