Senior Scientist to Director, Toxicologist

3 days ago

Suzhou, Jiangsu, China AccurEdit Therapeutics Full time $80,000 - $200,000 per year

该职位来源于猎聘 We are seeking a talented toxicologist to lead the execution of nonclinical toxicology studies, to serve as a toxicology representative, and to author toxicology content for regulatory submissions.

Responsibilities

  • Develops the toxicology strategy for the research and development programs in conjunction with the program teams.
  • Designs nonclinical safety studies, prepares study protocols, allocates appropriate resources, monitors the studies, and reviews the study reports
  • Reviews and follows the regulatory standards and guidelines (e.g., GLP)
  • Designs and performs investigative or non-standard toxicology studies as needed
  • Authors toxicology-related sections to support regulatory filings in China and ex-China
  • Interact with Research, Regulatory, Clinical, and CMC.

Minimum Qualifications

  • Ph.D. in toxicology or related field
  • Experience evaluating nonclinical safety of cell or gene therapies
  • 1-10 years of experience as a toxicologist at a biotech, pharmaceutical, or CRO; or 1-5 years of post-doctoral training; Experience in performing in vivo research studies
  • Highly organized and detail-oriented
  • Excellent oral and written communication skills
  • Ability to work independently and to collaborate with peers across various functions

Preferred Qualifications

  • Experience with large and small animal nonclinical models
  • Experience with lipid nanoparticle delivery of nucleic acid therapies
  • Experience in liver disease or rare disease drug discovery
  • Understanding of the evolving regulatory requirements for cell and gene therapy products in China and ex-China regions
  • Experience in authoring toxicology sections of regulatory documents for ex-China agencies

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