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Posted 7 hours ago
Sr. Scientist, Toxicology
Legend Biotech
Requirements
Ph.D., DVM, or PharmD in Toxicology or related field, 5+ years nonclinical toxicology experience, Knowledge of GLP and regulatory expectations, Experience with cell or gene therapy preferred
Skills
ToxicologyPharmacologyCell Therapy
About the role
Responsibilities
- Support toxicology activities for discovery and development-stage cell and gene therapy programs
- Design, monitor, interpret, and report nonclinical safety, pharmacology, biodistribution, and pharmacokinetic studies
- Support integrated interpretation of toxicology and pharmacology data to enable candidate selection and risk assessment
- Contribute to study strategy and execution at CROs, including protocol review and data interpretation
- Partner with Pharmacology, CMC, Clinical, Regulatory Affairs, and Program Management teams
- Support preparation of regulatory documents including pre-IND/IND submissions and investigator brochures
- Contribute to safety risk assessments related to target biology, immunogenicity, and genome-related risks
- Interpret complex nonclinical datasets and communicate findings to internal stakeholders
- Support in vivo pharmacology activities through integrated assessment of efficacy and safety findings
Requirements
- Ph.D., DVM, PharmD, or equivalent degree in Toxicology, Pharmacology, Immunology, or related discipline
- Minimum of 5 years of experience in nonclinical toxicology or related field in biotech/pharma R&D
- Working knowledge of pharmacology principles
- Understanding of FDA, EMA, and ICH regulations pertaining to toxicology and cell/gene therapy
- Strong scientific writing, communication, and presentation skills
- Ability to work independently in a collaborative, matrixed environment
Preferred Qualifications
- Experience supporting cell therapy, gene therapy, biologics, or other advanced therapeutic platforms
- Working knowledge of GLP toxicology studies and CRO management
- Experience contributing to IND/CTA-enabling packages and global regulatory submissions
About the Company
Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. 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.
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Get started — it's freeSr. Scientist, Toxicology
Legend Biotech · Philadelphia
