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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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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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The Department of Clinical Pharmacology Modelling and Simulation (CPMS) at GSK is recruiting for an Associate Director/or Director level Quantitative Systems Pharmacologist, with a robust background in Respiratory & Immunology.
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Lead or Co-lead all quantitative pharmacology activities to support both regulatory filings and internal decision-making (e.g., Exposure-Response, QTc prolongation risk assessment, population PK/PD analysis) by working closely with internal colleagues (i.e. DMPK, toxicology, biology, clinical, statistics) and external vendors to advance programs from Phase I to late-stage development.
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The ideal candidate will be an externally recognized and well respected expert in Clinical Pharmacology, population PK, pharmacometrics, and/or DMPK and have extensive experience applying innovative pharmacology approaches to IND filings, first in human dose prediction, drug development, dose recommendations for clinical studies, study design, dose decisions and health authority interactions.
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At 1910 Genetics, we put computation at the heart of drug discovery, blending expertise in computational chemistry, structural biology, pharmacology, genetics, data science, and software engineering to develop drugs for previously undruggable targets.
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B.S./B.A. in a relevant scientific field (e.g., molecular biology, pharmaceutical sciences, pharmacology, biomedical engineering); The ideal candidate will have experience in working with laboratory animals, and experience in one or more of the following areas: molecular biology, pharmacology, pharmaceutical sciences, and/or biomedical engineering.
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Responsibilities will include development and in vitro evaluation of drug delivery formulations - namely small molecule therapeutics and mRNA nanomedicines - and devices (~50% effort), and support preclinical evaluation of technologies in small and large animal models (~50% effort.
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The Dana-Farber/Boston Children’s Cancer and Blood Disorders Center is seeking a pediatric hematologist/oncologist at the Assistant Professor level with specialization in the area of stem cell transplantation at Boston Children’s Hospital (BCH) and Dana-Farber Cancer Institute (DFCI), with specific expertise in both survivorship and clinical pharmacology.
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Previous patent prosecution law firm experience, patent bar membership, and a background in one of the following fields: cell or molecular biology, immunology, biochemistry, bioinformatics, organic chemistry, medicinal chemistry, cancer biology, pharmacology.
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The Program Leader will lead a cross-functional team across clinical operations, regulatory affairs, clinical pharmacology, biomarkers, CMC, non-clinical, and medical to deliver against the program strategy.
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Hands-on experience establishing and optimizing in vivo pharmacology models and assays. PhD or MSc (with equivalent experience) in a relevant field (e.g., Biology, Biochemistry, Pharmacology, Toxicology, Engineering, Physics.
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Solid understanding of drug metabolism, bioanalysis, pharmacokinetics, preclinical pharmacology, PK/PD modeling and clinical study designs. Review preclinical study reports, in conjunction with Pharmacokinetics/DMPK and prepare regulatory submission documentation.
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Defining and delivering reporting content for use in managing clinical trial conduct in collaboration with other Clinical Operations and Clinical Data Management roles, Medical Monitors, Translational Medicine, Clinical Pharmacology, Biostatistics, and other internal and external stakeholders.
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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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histologist pharmacology jobs in Waltham, MA
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