Position Sr. Principal Scientist, Toxicology

Legend Biotech is seeking a Senior Principal 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.

The role requires scientific expertise in toxicology, a foundation in pharmacology, understanding of regulatory expectations, and the ability to work effectively across cross-functional teams in a fast-paced biotech environment. The successful candidate will provide scientific leadership for toxicology activities supporting cell and gene therapy programs, including emerging in vivo CAR-T platforms.

• Lead toxicology activities for in vivo CAR-T and other cell and gene therapy programs.
• Design, monitor, interpret, and report nonclinical safety, biodistribution, pharmacokinetic, immune toxicity, and related safety studies.
• Support integrated interpretation of toxicology and pharmacology data to enable candidate selection, risk assessment, and program progression.
• Interpret preclinical data from mouse and NHP models and provide risk assessments and development recommendations.
• Provide sponsor oversight for toxicology studies, including study planning, CRO management, protocol and report review, study monitoring, data interpretation, and issue resolution.
• Partner closely with Pharmacology, CMC, Clinical, Regulatory Affairs, and Program Management teams to advance development programs.
• Contribute to safety risk assessments related to target biology, exaggerated pharmacology, immunogenicity, biodistribution, insertional mutagenesis, and long-term safety.
• Support preparation of regulatory documents and submissions, including China IIT, IND applications, investigator brochures, global regulatory filings, and responses to health authority questions.
• Interpret complex nonclinical datasets and communicate key findings and recommendations clearly to internal stakeholders.
• Provide technical leadership for toxicology strategy, project initiation, and nonclinical development planning.
• Mentor junior scientists and contribute to the growth of toxicology capabilities within the organization.
• Support in vivo pharmacology activities, when needed, through integrated assessment of efficacy, disposition, and safety findings.

• Ph.D., DVM, PharmD, or equivalent degree in Toxicology, Pharmacology, Immunology, or a related discipline.
• Minimum of 8 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-enabling packages and global regulatory submissions is highly desirable.
• Understanding of NMPA, FDA, EMA, and ICH regulations pertaining toxicology and cell and gene therapy development.
• Experience evaluating immune-mediated toxicities, biodistribution, pharmacokinetics, insertional mutagenesis, and other safety considerations associated with advanced therapeutic platforms.
• Scientific writing, communication, and presentation skills.
• Demonstrated leadership, mentoring, and project management experience.
• Ability to work independently while thriving in a collaborative, matrixed team environment.