Toxicology Team Manager
Consultant Sandy Tang
Date posted 29 October 2018 2018-10-292018-12-28 pharmaceuticals No. 1 Songzhi Road Taipei Robert Walters Taiwan
A product-driven company engaging in the development of novel therapeutics for infectious diseases, and diabetes-related complications, is currently seeking a qualified, highly-motivated individual for the position of Toxicology Team Manager. The candidate is expected to demonstrate competency in interpreting toxicology data, development and implementation of strategic plans for nonclinical development, as well as providing expertise and guidance in Regulatory Toxicology to project teams.
- guide and support to project and product teams, including program and clinical/regulatory strategy
- generate Toxicology study protocols, reports, associated nonclinical summaries, Regulatory submission sections and associated documentation
- design, manage, analyse, review, summarise, interpret and report results of Toxicology and Safety Pharmacology studies
- maintain up-to-date Toxicology plans for all projects, programs, products, including listings of studies, timelines, status and costs; update and refine as necessary
- provide English/ Mandarin presentation to the R&D group
- PhD degree in Toxicology with 5 years industry-related experience or Master degree in Toxicology with 10 years industry-related experience in Toxicology working within the pharmaceutical or biotechnology industry.
- experience representing function to global regulatory agencies in support of submissions at all stages of development.
- demonstrated knowledge of global regulatory requirements, including good laboratory practice (GLP), Good clinical practice (GCP), International Conference on Harmonisation (ICH) and other applicable global guidelines.