[China Position] Sr. Principal Scientist, Toxicology

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 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.

Qualifications:

• 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.