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Along with other DMPK team members, they will collaborate across various cross-functional teams including biology, chemistry, clinical pharmacology, toxicology and formulations, contributing to the prediction of human efficacious dose across lead optimization and candidate nomination and contribute to internal dossiers & regulatory responses for small/large molecules and novel modalities.
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Experience of working under own initiative and in planning and prioritizing workloads University or technical college degree or equivalent qualification in relevant sciences such as: Medicine, Pharmacy, Chemistry, Biochemistry, Biology, Microbiology, Biotechnology, Health Technology, Toxicology, Physics, Biophysics, Material Science Biomedical Engineering, Mechanical, Electrical or Electronic Engineering, Computer & Software Technology, Human Physiology, Nursing, Quality Management.
$103,500 - $170,800 a yearFull-timeRemoteExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Takeda Development Center Americas, Inc. is seeking a Senior Manager, Clinical Data Management in Lexington, MA with the following requirements: Master’s degree in Pharmaceutical Sciences, Pharmacology or Toxicology or related field or foreign academic equivalent plus 6 years of related experience.
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This individual will report to the Head of Toxicology and will be responsible for implementing the in vivo strategy for preclinical programs across Orbital and will design and oversee early toxicology study.
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Prior experience must include: Develop and maintain study-specific data management documentation such as CRF Specifications, Edit check specifications, Data Management Plan, and Data Cleaning Plan documentation, etc.
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Our client offers preclinical services for drug discovery, focused on the use of nonhuman primates to determine pharmacokinetics, pharmacology and toxicology of small molecules and biologics. 5+ years of experience in scientific sales in the Life-science industry (Toxicology, Pharmacology, Primates desired.
ExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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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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Bachelor’s degree in scientific-related field with a minimum of 6+ years of relevant experience in toxicology or related field (as study director or toxicology study manager is a plus) or a Master’s degree with a minimum of 5+ years of relevant experience.
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The modeler will collaborate closely with scientists across the non-clinical (in vivo pharmacology, bioanalysis, and toxicology) and clinical teams to provide feedback on interpretation of experimental data and on study design to advance the understanding of gene editing drugs.
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10 years of experience within toxicology study design, execution and analysis, or equivalent knowledge through relevant practical experience. Work closely with Nonclinical Study Managers to oversee and manage the outsourced nonclinical development toxicology studies with regards to deliverables, timelines and budgets.
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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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Bachelor or higher degree in scientific-related field, and at least 3 years of experience in toxicology, pharmacology, pharmacokinetics, immunology, biological sciences, or related discipline. Coordinate the receipt of study samples with Visterra BioAnalytical team; oversee distribution, inventory, and archiving.
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Manage CROs for DMPK and Clinical Pharmacology related studies and activities inclusive of developing and negotiating study timelines; ensuring accuracy of project delivery and pro-actively identifying hurdles and providing solutions.
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Experience of study design, data interpretation and application of non-clinical developmental, reproductive and juvenile toxicology data in GLP studies. Regulatory Toxicology & Safety Pharmacology is a global department within the Clinical Pharmacology and Safety Sciences (CPSS) function; we’re looking to recruit a talented and experienced reproductive toxicologist to join our reproductive toxicology team.
Full-timeExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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As a study monitor, direct and oversee nonclinical toxicology studies including but not limited to genetic toxicology, safety pharmacology, general toxicology, and development and reproductive toxicology studies supporting nonclinical and clinical development programs.
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toxicology study jobs in Somerville, MA
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