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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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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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Director of Toxicology leads nonclinical safety within Preclinical Development and is responsible for coordinating nonclinical safety to adequately support BlueRock programs from research through development stages.
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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.
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They have the comprehensive responsibility for designing and executing the early clinical drug development phase together with a project team from researcher, biomarkers, biostatistics, modelling & simulation, toxicology, technical experts and the clinical trial teams.
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Our Translational Medicine Experts (TME) are part of preclinical project teams in all drug discovery phases and help design the pathway for First in Human (FIH) studies (healthy volunteer) that bridge to studies in the patient population.
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Understanding and application of pharmacology, chemistry and non-clinical toxicology to effectively inform the conduct of safety surveillance Ability to thrive in a fast-paced environment while providing appropriate attention to detail.
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The group closes the gap between preclinical research and clinical development and integrates clinical science into the discovery and preclinical development phase. As a Translational Medicine Expert (TME), you will provide medical and scientific expertise that drives the success of early drug development, global clinical studies, and strategies to achieve clinical Proof-of-Concept in the Nephrology disease area, and to progress towards new treatments for unmet medical needs.
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Must have facility with the interpretation of preclinical data in heme/oncology (molecular biology, pharmacology, pharmacokinetics, and toxicology) Integrates preclinical information (pharmacology, toxicology, pharmacokinetics) and interprets its implications for clinical development, as articulated in the Investigator's Brochure and first-in-human protocol.
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You will be an SME for genotoxicity and gene editing products working closely with Computational Biology, Toxicology, Genomics Innovation and PreClinical Genotox to support the development of genome editing based therapeutics into the clinic.
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This position will work cross-functionally to ensure projects are coordinated with partners from multiple departments within Alkermes including regulatory, preclinical research, clinical pharmacology, translational medicine, toxicology, CMC, new product planning, project management, patient engagement, health economics, legal, finance, medical affairs and commercial.
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Responsible for conducting toxicology and medical device studies in compliance with GLP/CNAS. As a study pathologist, attend all key activities of preclinical studies regarding pathology, perform macroscopic and microscopic examination, evaluate pathological data and write comprehensive pathology report.
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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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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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Accountable for the design, execute, and critical analysis of nonclinical in vitro and/or in vivo studies conducted in multiple species via collaborative partnerships with study monitors and other partner line program representatives (e.g., toxicology, bioanalytical, operations, etc.
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toxicology preclinical jobs in Waltham, MA
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