[China Position] Sr. Principal Scientist, Toxicology
Legend Biotech
August 31, 2026
Remote friendly (New Jersey, United States)
United States
Clinical Research and Development
Role Responsibilities:
- 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.
- Integrate toxicology and pharmacology data to support candidate selection, risk assessment, and program progression.
- Interpret mouse and NHP preclinical data and provide risk assessments and development recommendations.
- Provide sponsor oversight for toxicology studies (study planning, CRO management, protocol/report review, monitoring, data interpretation, issue resolution).
- Partner with Pharmacology, CMC, Clinical, Regulatory Affairs, and Program Management teams.
- Contribute to safety risk assessments (target biology, exaggerated pharmacology, immunogenicity, biodistribution, insertional mutagenesis, long-term safety).
- Support regulatory document preparation/submissions (China IIT, IND applications, investigator brochures, global filings, responses to health authority questions).
- Interpret complex nonclinical datasets and communicate findings/recommendations.
- Provide toxicology technical leadership for strategy, project initiation, and nonclinical development planning.
- Mentor junior scientists; support growth of toxicology capabilities.
- Support in vivo pharmacology activities as needed via integrated efficacy/disposition/safety assessment.
Qualifications:
- Ph.D., DVM, PharmD, or equivalent in Toxicology, Pharmacology, Immunology, or related field.
- 8+ years in nonclinical toxicology (or related) in biotech/pharma R&D; knowledge of pharmacology principles.
- GLP toxicology and nonclinical pharmacology study knowledge; CRO management and regulatory expectations.
- Experience with IND-enabling packages and global regulatory submissions (highly desirable).
- Knowledge of NMPA, FDA, EMA, and ICH regulations for toxicology and cell/gene therapy.
- Experience evaluating immune-mediated toxicities, biodistribution, pharmacokinetics, insertional mutagenesis, and other safety considerations.
- Scientific writing, communication, presentation, leadership, mentoring, and project management skills.
- Ability to work independently in a collaborative, matrixed environment.
- 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.
- Integrate toxicology and pharmacology data to support candidate selection, risk assessment, and program progression.
- Interpret mouse and NHP preclinical data and provide risk assessments and development recommendations.
- Provide sponsor oversight for toxicology studies (study planning, CRO management, protocol/report review, monitoring, data interpretation, issue resolution).
- Partner with Pharmacology, CMC, Clinical, Regulatory Affairs, and Program Management teams.
- Contribute to safety risk assessments (target biology, exaggerated pharmacology, immunogenicity, biodistribution, insertional mutagenesis, long-term safety).
- Support regulatory document preparation/submissions (China IIT, IND applications, investigator brochures, global filings, responses to health authority questions).
- Interpret complex nonclinical datasets and communicate findings/recommendations.
- Provide toxicology technical leadership for strategy, project initiation, and nonclinical development planning.
- Mentor junior scientists; support growth of toxicology capabilities.
- Support in vivo pharmacology activities as needed via integrated efficacy/disposition/safety assessment.
Qualifications:
- Ph.D., DVM, PharmD, or equivalent in Toxicology, Pharmacology, Immunology, or related field.
- 8+ years in nonclinical toxicology (or related) in biotech/pharma R&D; knowledge of pharmacology principles.
- GLP toxicology and nonclinical pharmacology study knowledge; CRO management and regulatory expectations.
- Experience with IND-enabling packages and global regulatory submissions (highly desirable).
- Knowledge of NMPA, FDA, EMA, and ICH regulations for toxicology and cell/gene therapy.
- Experience evaluating immune-mediated toxicities, biodistribution, pharmacokinetics, insertional mutagenesis, and other safety considerations.
- Scientific writing, communication, presentation, leadership, mentoring, and project management skills.
- Ability to work independently in a collaborative, matrixed environment.