Lead Toxicology Scientist, Cell & Gene Therapy

Legend Biotech; New Jersey; On-site; USD 180,000 - 240,000; Full time

Job summary

Legend Biotech is seeking a Senior Principal Scientist, Toxicology to support nonclinical development across cell and gene therapy programs, from discovery through IND-enabling development. This role will provide scientific leadership for toxicology activities and collaborate across Regulatory, Pharmacology, Clinical, and Program Management teams.

You will lead in vivo toxicology studies, interpret complex data, and provide risk assessments to enable candidate progression while coordinating with

Qualifications

• Ph.D. or equivalent in Toxicology, Pharmacology, Immunology, or related field.
• 8+ years in nonclinical toxicology within biotech/pharma R&D.
• Experience with cell/gene therapy platforms preferred.
• Working knowledge of GLP toxicology studies and CRO management.
• IND-enabling packages and global regulatory submissions desirable.
• Understanding of NMPA, FDA, EMA, and ICH regulations for toxicology and CGT.
• Experience evaluating immune-mediated toxicities, biodistribution, PK, and safety.
• Scientific writing, communication, and presentation skills.
• Leadership, mentoring, and project management experience.
• Ability to work independently in a collaborative, matrixed team environment.

Responsibilities

• Lead toxicology activities for in vivo CAR-T and other cell and gene therapy programs.
• Design, monitor, interpret, and report nonclinical safety, biodistribution, PK, and immune toxicity studies.
• Support integrated interpretation of toxicology and pharmacology data for candidate selection and risk assessment.
• Interpret preclinical data from mouse and NHP models and provide risk assessments.
• Provide sponsor oversight for toxicology studies, CRO management, protocol and report review.
• Partner with Pharmacology, CMC, Clinical, Regulatory Affairs, and Program Management teams.
• Contribute to safety risk assessments for target biology, exaggerated pharmacology, and long-term safety.
• Support regulatory documents and submissions (INDs, IITs, global filings).
• Interpret complex datasets and communicate findings to stakeholders.
• Provide technical leadership for toxicology strategy and nonclinical development planning.
• Mentor junior scientists and grow toxicology capabilities.

Skills

Toxicology

Pharmacology

Regulatory knowledge

CRO management

IND submissions

Leadership

Data interpretation

Cross-functional collaboration

Mentoring

Project management

Education

Ph.D., DVM, PharmD, or equivalent in Toxicology/Pharmacology/Immunology

Job description

Legend Biotech is seeking a Senior Principal Scientist, Toxicology to support nonclinical development across cell and gene therapy programs, from discovery through IND-enabling development. This role will provide scientific leadership for toxicology activities and collaborate across Regulatory, Pharmacology, Clinical, and Program Management teams.

You will lead in vivo toxicology studies, interpret complex data, and provide risk assessments to enable candidate progression while coordinating with