Director of Toxicology
Core
Oversees China-based CRO nonclinical toxicology studies and supports regulatory submissions for drug development programs.
Role type
Director of nonclinical toxicology
Builds
Nonclinical safety assessment data and regulatory documentation for drug candidates
Domain
Pharmaceutical nonclinical safety and regulatory affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
nonclinical toxicology study direction, GLP compliance, Chinese regulatory strategy, regulatory document preparation, vendor management, cross-functional collaboration
Preferred skills
experience with biologics, ADCs, cell and gene therapies, oncology, neuroscience, immunology
Technologies
Microsoft Word, Excel, PowerPoint
Responsibilities
Liaise with China-based CROs to ensure effective study initiation, conduct, and completion; prepare briefing books, CTDs, and responses to CDE inquiries; monitor nonclinical toxicology studies; conduct test facility inspections; author and submit regulatory documents (IBs, INDs/CTAs, NDAs/BLAs); resolve scientific and technical issues during drug development.
Seniority
Director, strategic oversight & execution
