Job Description
- To propose safety and preclinical strategies, design and coordinate appropriate non-GLP and GLP Tox to support preclinical development of drug candidates successfully IND filing
- To implement tox studies in preparing protocols, monitoring study progress, analyzing data and writing reports and regulatory documentation and filing
- To coordinate cross-functional effort (Discovery, Pharmacology, PKPD, BioAnalytical, CMC and business partners) in planning budgets, timelines and resource allocations
- To participate meeting and teleconference with global clients/team members during after work hours
- To communicate with regulatory agencies in defending preclinical packages
- Might supervise and team build team, depending upon qualification, a group of SDs
Requirement
- A MD, MS or PhD in biochemistry, biology, DMPK preferably tox
- In-depth knowledge of preclinical toxicology (in vitro and in vivo), SOP, guidelines and GLP principles is must
- Well understanding of FDA, cFDA, and EMA regulations and registrations required
- Prior experience in preclinical development in life science industry highly desired
- Hands on experience in animal study and/or biology assay, Pharmacokinetics, Metabolisms, and Bioanalytical assay highly expected
- Excellent interpersonal and communication in both Chinese and English
- Strong collaborative skills and ability to work in a team environment expected
Location: ZJ Hi-tech Park,Shanghai, China
English 
Chinese