Director of Toxicology

📋 Description

• Serve as the liaison between AbbVie and the China-based CRO, ensuring the effective initiation
• Maintain ongoing communication with the appropriate AbbVie US stakeholders throughout the study
• Support development programs and regulatory submissions by preparing appropriate documentation
• Work closely with the US-based DBS development representative and/or study monitor to ensure
• Strong knowledge of CDE regulatory guidance and processes related to the development and
• Prepare nonclinical documents to support clinical studies and regulatory submissions in China

🎯 Requirements

• PhD, DVM or MD required
• Minimum of 10 years of relevant experience in the pharmaceutical industry leading nonclinical
• Experience preparing relevant regulatory documents and responding to requests from regulatory
• Experience in nonclinical toxicology study conduct, GLP knowledge and expectations, and associated
• Familiarity with global guidance, including China, U.S., and EMA requirements supporting
• Professional proficiency in both Chinese and English