A Contract Research Organisation with a site near Earby, is looking for a Head of Toxicology to manage and lead the non-clinical activities necessary for a premarket product application or medicinal product submission. You will be responsible for assuring that accurate plans are created for the toxicology streams to follow in order to be successful in client submission.
The successful candidate will have a background in Toxicology and strong people management skills; along with the ability to plan complex regulatory toxicology studies.
Key person specification:
• Degree in Toxicology or related field (essential)
• PhD in Toxicology (desirable)
• Registered toxicologist (ERS or DABT)
• At least 5 years’ experience in applied toxicology and risk assessment
• Experienced in Good Laboratory Practices (GLP)
• Be knowledgeable with and have experience with FDA CTP recommendations for in vitro
studies for PMTA submissions.
• Have a certification in Good Laboratory Practices (GLP).
• Be knowledgeable with OECD study design.
• Experience with computational modelling software: OECD Toolbox, ToxTree and Lhasa
• Proven ability in technical writing and communications.
• Experience with in vitro/in vivo extrapolation (IVIVE)
• Experience with physiologically based pharmacokinetic (PBPK) models, including
absorption, distribution, metabolism, and excretion of any given chemical
• Experienced in cell culture technologies
• Proven self-learner.
• Can demonstrate business / commercial acumen.
• Proven project management skills.
• Can demonstrate drive and motivation
For a full role brief, please apply with your full CV.
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