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Since its inception, QPS 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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Experience with GLP (Good Laboratory Practice) and non-GLP toxicology studies. Associate Director, Toxicology - Cell & Gene TherapyAre you a seasoned Toxicologist ready to influence the future of Cell & Gene Therapy (CGT.
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Lead and manage the Pre-Clinical QA external vendor audit program for all outsourced regulated GLP toxicology, nonclinical and clinical bioanalytical, and clinical laboratories. Ensure regulated internal bioanalytical laboratories and associated functions (toxicokinetic and pharmacokinetic) meet all GLP requirements for nonclinical and clinical study sample analyses.
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Immediate opening for a Clinical Laboratory Scientist/Medical Technologist for a (COLA) Toxicology Laboratory in Washington, D.C. To work to the Company’s quality procedures in accordance with Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) regulations and be involved in working to and generating a culture of continuous improvement.
$28 - $35 an hourExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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Act as the Global Pharmacology and Toxicology Lead for developmental programs, assisting in their design, completion, and defense. Key Responsibilities:Apply scientific methods and propose solutions to challenges in pharmacology and toxicology, based on interpretation of past results, studies, or external information.
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Design study protocols and execute external non-GLP andGLP nonclinical development toxicology studies. Global Discovery and Development Sciences (GDDS) Boston,part of the US R&D hub, is building a new siRNA NonclinicalDevelopment department with cross-functional scientificexpertise, including toxicology, safety pharmacology, PKPD,ADME, outsourcing management, and non-clinical projectmanagement.
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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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From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market.
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Responsible for all areas of preclinical research and development, including generating pharmacology and toxicology data, preclinical trial strategy and design, preparation of the preclinical development plan to support successful INDs, and contribution to regulatory strategy.
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Job Segment: Database, Toxicology, Biotech, Pharmaceutical, Science, Technology, Research. Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance.
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The incumbent in this role will design, implement, and effectively execute exploratory and GLP toxicology studies to meet MacroGenics' objectives within a fast-paced, rapidly changing organization.
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Associate Director, Toxicology - Cell & Gene Therapy. Ph. D. in Toxicology, Pharmacology, or a related field. Analyze and interpret study data, draw meaningful conclusions,make recommendations, and prepare comprehensive toxicology reports for clients and regulatory submissions.
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You have at least 5-10 years experience as a study monitor and/or study director conducting non-GLP and GLP toxicology studies, e.g. as Study Director at a CRO or in a pharma company.
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The DMPK group works in close partnership with disciplines such as medicinal chemistry, pharmacology, toxicology, pharmaceutical sciences, clinical pharmacology, and regulatory to optimize leads, select clinical candidates, conduct preclinical development studies, support clinical evaluation and contribute to IND and NDA filings.
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Lead and/or manage the design, monitoring, and interpretation of In Vitro, In Vivo, or pre-clinical bio-compatibility studies conducted under Good Laboratory Practices (GLP). Interpreting the results of Biological/Volatile Organic Compound tests for impacts to patient safety and preparation of expert reports on toxicology/patient risk in the support of regulatory documentation.
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