Description

Legend Biotech is seeking Sr. 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.

#Li-JK1

#Li-Hybrid

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.

Benefits

We are committed to creating a workplace where employees can thrive - both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best-in-class benefits package that supports well-being, financial stability, and long-term career growth. Our offerings are designed to meet the diverse needs of our team members and their families, ensuring they feel valued and supported every step of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company match that vest fully on day one. Equity and stock options are available to employees in eligible roles, we offer eight weeks of paid parental leave after just three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs - demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

EEO Statement

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions.

Legend Biotech maintains a drug-free workplace.