Thomas G. Smith Email & Phone Number

ACTIVELY seeking interesting and challenging opportunities!Extensive experience in non-clinical drug safety and development within major pharma and CRO industries.Presently (Shire):• Senior Toxicologist, designing/overseeing the outsourcing/monitoring of general, juvenile and reproductive toxicity studies and supportive bioanalytical: Ensuring high standards of scientific integrity and regulatory compliance. CRO qualification, site inspection, performance management. Protocol and report scientific review. Communication of results to team and Senior Management. Preparing recommendations and solutions for project success.• Project toxicologist: recombinant proteins, monoclonal antibodies/fragments, oncology and small molecules for treatment of rare disease. Overseeing the design/management of all non-clinical project phases and reviewing regulatory documentation.• Juvenile, Reproductive & Developmental Toxicology subject matter expert.• Member of the Non-clinical Pediatric Industry Forum.Previously (Baxter/Baxalta):• Tox, outsourcing and monitoring as described for Shire.• Project Team Member for the Vaccines and Biosimilars franchises. Contributing to project and risk management plans. Preparing and reviewing regulatory documentation to support clinical trials and submissions.• Member of the Vaccines Franchise Team (Senior Management).• Due diligence activities.• European Vaccines Manufacturers working party member.Previously (GSK):• Developed and implement global strategies, knowledge sharing and process improvement.• Designed pre-clinical safety studies.• Monitored tox & carcinogenicity studies in EU, USA, Canada & Asia for the whole portfolio.• Ensured work conducted to protocol, GLP, in compliance with regulations and best practice, then reported accurately, on time and to a high scientific standard.• CRO performance management, qualification visits and site inspections.• Scientific & managerial issue resolution.

Listed skills include Toxicology, Preclinical, Preclinical Monitor, Clinical Development, and 20 others.

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  The University Of Hull

  Zoology