Sr. Scientist, Toxicology

About the role

Legend Biotech is seeking a Sr. Scientist, Toxicology to support nonclinical development and safety assessment across cell and gene therapy programs. This individual will contribute to nonclinical strategy from discovery through IND-enabling development and support regulatory submissions for innovative advanced therapies.

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, risk assessment, and program progression.
• Contribute to study strategy and execution at CROs, including protocol review, study monitoring, data interpretation, and final report review.
• Partner closely with Pharmacology, CMC, Clinical, Regulatory Affairs, and Program Management teams to advance development programs.
• Support preparation of regulatory documents, including briefing packages, pre-IND/IND submissions, investigator brochures, and responses to health authority questions.
• Contribute to safety risk assessments related to target biology, exaggerated pharmacology, off-target effects, immunogenicity, genome-related risks, and long-term safety.
• Interpret complex nonclinical datasets and communicate key findings and recommendations clearly to internal stakeholders.
• Stay current with scientific and regulatory advances relevant to toxicology, pharmacology, and cell and gene therapy development.
• Support in vivo pharmacology activities, when needed, through integrated assessment of efficacy, disposition, and safety findings.

Requirements

• Ph.D., DVM, PharmD, or equivalent degree in Toxicology, Pharmacology, Immunology, or a related discipline.
• Minimum of 5 years of experience in nonclinical toxicology or a related field within biotechnology or pharmaceutical R&D, with working knowledge of pharmacology principles.
• Experience supporting cell therapy, gene therapy, biologics, or other advanced therapeutic platforms preferred.
• Working knowledge of GLP toxicology studies, nonclinical pharmacology studies, CRO management, and regulatory expectations for nonclinical development.
• Experience contributing to IND/CTA-enabling packages and global regulatory submissions is highly desirable.
• Understanding of FDA, EMA, and ICH regulations pertaining to toxicology and cell and gene therapy development.
• Scientific writing, communication, and presentation skills.
• Ability to work independently while thriving in a collaborative, matrixed team environment.