Sr. Director of Toxicology

Legend Biotech US • Philadelphia, PA

85d

About The Position

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.

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.

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.

Benefits

• Medical, dental, and vision insurance.
• 401(k)-retirement plan with company match that vests fully on day one.
• Equity and stock options available to employees in eligible roles.
• Eight weeks of paid parental leave after just three months of employment.
• Paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays.
• Flexible spending and health savings accounts.
• Life and AD&D insurance.
• Short- and long-term disability coverage.
• Legal assistance.
• Supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance.
• Commuter benefits.
• Family planning and care resources.
• Well-being initiatives.
• Peer-to-peer recognition programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree
• Number of Employees: 1,001-5,000 employees