Principal Research Scientist II, Toxicology
Core
Director-level professional overseeing nonclinical toxicology studies in China, serving as the liaison between AbbVie and China-based CROs to ensure study initiation, conduct, and completion, while supporting regulatory submissions.
Role type
Director-level nonclinical toxicology study director and regulatory affairs lead
Builds
Nonclinical safety assessment data and regulatory documentation for drug candidates
Domain
Pharmaceutical nonclinical safety and regulatory affairs in China
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
nonclinical toxicology study direction, GLP study conduct, Chinese regulatory compliance, regulatory document preparation, CDE inquiry response, vendor management, multi-drug modality safety assessment
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 manage nonclinical toxicology studies; prepare nonclinical documents for clinical studies and regulatory submissions; respond to CDE inquiries; monitor nonclinical toxicology studies; conduct China test facility inspections; manage vendor relationships; resolve study conduct issues
Seniority
Director, strategic oversight and execution