Legend Biotech · 2 months ago
Sr. Director of Toxicology
Philadelphia, PA
Full-time
Onsite
Director/Executive
10+ years expLegend Biotech is a global biotechnology company dedicated to treating life-threatening diseases. They are seeking a highly experienced and strategic Senior Director of Toxicology to lead and oversee all nonclinical safety assessment activities for their cell and gene therapy programs.
BiotechnologyHealth CareLife ScienceOncologyTherapeutics
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
Qualification
Required
Ph.D., DVM, or equivalent in Toxicology, Pharmacology, or related field
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
Preferred
DABT certification preferred
Immunology training is desired
Benefits
Medical, dental, and vision insurance
401(k)-retirement plan with company match that vest fully on day one
Equity and stock options
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
Company
Legend Biotech
Legend Biotech is a biopharmaceutical company that develops and commercializes novel cell therapies for oncology.
1001-5000 employees
H1B Sponsorship
Legend Biotech has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (30)
2024 (11)
2023 (14)
2022 (7)
2021 (6)
2020 (13)
Funding
Current Stage
Public CompanyTotal Funding
$750.45M2023-05-05Post Ipo Equity· $350M
2022-07-25Post Ipo Equity· $250M
2020-06-05IPO
Leadership Team
Carlos Santos
Chief Financial Officer
Alan Bash
President, CARVYKTI
Recent News
2025-12-18
thefly.com
2025-12-09
Company data provided by crunchbase