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Perform preclinical pharmacology studies in rodents. Its service platform integrates preclinical studies with innovative animal models, CRISPR-based gene editing, and animal supplies, with the current focus on immuno-oncology and oncology.
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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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Strong knowledge of pharmacokinetics and pharmacodynamics principles, immunogenicity, modelling and simulation, Model-Informed Drug Development, ADME Concepts, and regulatory clinical pharmacology requirements to support clinical development and regulatory submission.
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A minimum of 10 years of related pharmaceutical or biotechnology industry experience in clinical pharmacology, population PK, PK-PD modeling, DMPK, and/or pharmacometrics and a proven track record advancing programs through the drug development process, from discovery through IND to registration, informing data driven decisions on dose and schedule, making tough judgement calls where needed.
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Comprehensive understanding of DMPK and pharmacology/safety aspects of drug discovery and development with a strong publication record. PhD in a subject area with a significant component of analysis and quantitation, such as systems biology, quantitative pharmacology, pharmacometrics, chemical engineering, physics, pharmaceutical sciences or applied mathematics with a minimum of 3 publications in peer reviewed journals.
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Global Discovery and Development Sciences (GDDS) Boston, part of the US R&D hub, is building a new siRNA Nonclinical Development department with cross-functional scientific expertise, including toxicology, safety pharmacology, PKPD, ADME, outsourcing management, and non-clinical project management.
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Data quality surveillance of CRF and external/non-CRF clinical trial data (e.g. Biosample Lab Data, Biomarker Data, Imaging) in collaboration with other Clinical Operations roles, Medical Monitors, Translational Medicine, Clinical Pharmacology, Biostatistics, and other internal and external stakeholders.
ExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Head up the development team starting at the time of CTA/IND or proof of concept depending on the program, including all functions: clinical, regulatory, biostatistics, program management, clinical operations, tech ops/CMC, clinical pharmacology, research, and preclinical development, to design and execute clinical development plans for assigned projects.
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Supervise the execution of pharmacology studies at CROs and perform in-house downstream analysis to support drug discovery program needs. This candidate will play an active role in animal model development for pharmacology studies to address biological hypotheses.
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Research Associate / Sr. Research Associate of in vivo Pharmacology. Research Associate / Sr. Research Associate of in vivo Pharmacology. Proficient in standard in vivo techniques (animal handling, blood collection, dosing (SQ, IV, IM, and IP), necropsy, tissue dissections.
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Ph. D./M.S. in clinical pharmacology, pharmacokinetics and metabolism, pharmacometrics, chemical/biomedical engineering, computational biology/chemistry or a related field with 0-5 years' pharmaceutical industry /academic experience.
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Strong understanding of all aspects of compound optimization including synthetic chemistry, structure-based drug design, ligand-based drug design, pharmacokinetics, pharmacology, and toxicology.
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Support DMPK needs for clinical stage programs through close collaboration with Clinical Pharmacology and Toxicology. Work closely with DMPK CROs to design, coordinate, monitor and manage external ADME and PK studies.
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Job Description:Senior Research Associate Contractor will support assay development, in vitro pharmacology and ex vivo analyses across multiple therapeutic areas, including but not limited to metabolic/cardiovascular disease, oncology and inflammation.
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Ph. D. in Cell Biology, Biochemistry, Pharmacology, or other related discipline or M.S. with 2+ years direct experience with integrated HTS lab automation & laboratory information management systems (LIMS); M.S. degree with 5+ years of relevant experience.
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