Position Sr. Principal Scientist, Toxicology

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.

• 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.