Assistant Director/Associate Director/Director in Toxicology

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

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Headquarters

1F & 3F, Block A
2829 JinKe Road
Zhangjiang Hi-Tech Park
PuDong New Area
Shanghai China, 201203

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Contact Us

China: +86 21 5132 0088
US: +1 650 419 9974
Europe: +45 4586 9000
Japan: +81 03 5403 6975

contact@chempartner.com