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Understanding of the related disciplines (i.e. biostatistics, regulatory, pharmacology and toxicology research, cell therapy manufacturing, clinical pharmacology and pharmaceutical sciences) Reporting to the Head of Clinical Development, this individual will have oversight of and accountability for clinical trials from study start-up to BLA approval.
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Education/Experience (BMQ) M.A. or M.S. with 8 years relevant experience Ph. D. with 5 years relevant experience Combination of Education and Relevant Experience in ADME Toxicology Applications Supervisory Responsibility : None Ability / Skills (BMQ) : Direct experience with Liquid Chromatography- Mass Spectrometry and/or ultraviolet spectrometry (LC-MS or LC-UV) in a contract research organization or industry laboratory for ADME/ DMPK applications.
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The position includes study design and implementation, development of relationships with Toxicology CROs and University Discovery Pharmacology activities, data reduction, data interpretation, and data presentations.
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We have an exciting opportunity for a Toxicology Study Director / Pharmaceutical and Medical Device. SUMMARY The Toxicology Study Director is responsible for managing the design, execution, and reporting of studies, meeting all scientific, regulatory and client requirements.
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On toxicology, biodistribution, pharmacokinetic, and related studies to ensure study execution, client engagement, and deliverables upon study completion. safety, efficacy, and toxicology unit (ASET) was launched as a preclinical CRO that spun out of Battelle in 2021 to address the changing needs of commercial organizations developing modern therapeutics.
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Advanced degree or PhD in toxicology or a closely related field of study (pharmacology or veterinary medicine); DABT and/or DVM degree will be an advantage. Design study protocols and execute external non-GLP and GLP nonclinical development toxicology studies.
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Safe and timely execution of Phase I studies; close collaboration with internal and external clinical study support staff and scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations.
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Toxicology systematic review tasks including literature screening, study quality evaluation, study data extraction, dose-response analysis, incorporation of NAMs and mechanistic data, and data synthesis.
$70,374 - $119,636 a yearFull-timeExpandUpdated Today - UpvoteDownvoteShare Job
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Safety or occupational health fields (safety, occupational health, industrial hygiene), or degree in other related fields that included or was supplemented by at least 24 semester hours of study from among the following (or closely related) disciplines: safety, occupational health, industrial hygiene, occupational medicine, toxicology, public health, mathematics, physics, chemistry, biological sciences, engineering, and industrial psychology.
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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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Perform Study Director duties as needed. Inotiv is seeking a Vice President of Toxicology to join our team. Possesses both broad fundamental and detailed specialized knowledge in the area of toxicology.
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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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Analyze and interpret study data, draw meaningful conclusions,make recommendations, and prepare comprehensive toxicology reports for clients and regulatory submissions. Key Responsibilities: Lead the design and planning of toxicology studies, including selecting appropriate study models and endpoints.
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Associate Director, Toxicology - Cell & Gene TherapyAre you a seasoned Toxicologist ready to influence the future of Cell & Gene Therapy (CGT)? Your New Chapter Awaits:As a Senior Study Director in the CGT department, you’ll play a pivotal role in advancing the science that keeps us all safe.
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Act as the lead clinical pharmacologist on clinical pharmacology study teams to support clinical development: independently lead the design, protocol development, execution, analysis, and reporting of clinical pharmacology studies (e.g., food effect, BA/BE, human ADME, drug interactions, renal and hepatic impairment, etc.
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toxicology study jobs
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