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The Toxicologist will collaborate with external vendors, the internal preclinical pharmacology and toxicology team, and other stakeholders across the company to ensure efficient processes that scale with Verve's continued growth.
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Provide scientific and administrative leadership to a growing organization with particular strength in preclinical toxicology, cancer prevention and therapy, and infectious disease. Perform preclinical drug efficacy evaluations and safety assessments for sponsors in the pharmaceutical, biotechnology, and chemical industries, as well as for the National Institute of Health (NIH), Department of Defense, and other branches of the federal government.
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The Study Director, Research Scientist will have a passion for preclinical research. Three years’ experience as a Study Director for in vivo studies (including GLP) in a biopharmaceutical company or Contract Research Organization (CRO) One to two years’ experience in Toxicology a plus.
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We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development.
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Additionally, you will provide subject matter expertise in some of the areas of toxicology that include fit-for-purpose safety biomarker development and validation, bio-fluid/tissue biomarker analysis, in silico, genetic, endocrine, and reproductive toxicology efforts to support on-going development of preclinical candidates.
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Review preclinical study reports, in conjunction with Pharmacokinetics/DMPK and prepare regulatory submission documentation. Author DMPK, nonclinical toxicology, and biomarker sections of regulatory documents.
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Sanofi is seeking an innovative investigative toxicologist to join our Preclinical Safety organization in a position that offers exciting and challenging scientific opportunities in a global environment.
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Experience with in vivo preclinical ADME studies and understanding of clearance route and mechanism, and the role of metabolism/catabolism is essential. Our client has been assisting pharmaceutical, biotechnology and medical device companies with their drug development efforts by providing a full range of Neuropharmacology, DMPK, Toxicology, Bioanalysis, Translational Medicine, Early Phase Clinical and Phase II - IV Clinical Research services.
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This position will function within the Toxicology Unit of Corporate Preclinical Development and Toxicology (CPDT) and will support the conduct of nonclinical laboratory investigations of medical devices and materials in accordance with GLP regulations and the client's CPDT Quality System.
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Design toxicity studies: coordinate with Preclinical Outsourcing for placement and monitoring of the studies as well as the Bioanalytical and DMPK groups regarding integration of bioanalysis and toxicokinetic aspects into these studies to ensure on-time delivery of key data and study reports.
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Oversee and provide strategic direction for Toxicology/Pathology, BioAnalytical/DMPK, Biomarkers, and Clinical Pharmacology teams to ensure robust support for clinical development programs. 12+ years of experience in the biopharma industry in non-clinical development (toxicology, pharmacology, pharmacokinetics, bioanalytical sciences, or related discipline.
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Interface broadly with key functions including Discovery Sciences, Preclinical Pharmacology, Pharmaceutical Sciences, Toxicology, Translational Biomarkers, Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs, and late stage Clinical Research throughout sites in the USA, UK and Belgium.
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Qualifications and Experience:PhD in Pharmacology, Oncology, Pharmaceutical Sciences, Toxicology, or a related field, coupled with a minimum of 5 years of pertinent experience, or equivalent industry exposure in preclinical drug discovery and development.
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Director of Business Development – Drug Safety, Toxicology, & Preclinical Services. Title: Director of Business Development – Drug Safety, Toxicology, and Preclinical Services.
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Is a newly established, commercially focused preclinical CRO that was created as a Battelle spin-off. will join a staff of highly trained scientist and technicians, and state of the art facilities to support our clients’ toxicology, safety pharmacology, and inhalation research programs in our animal care division.
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