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This includes all Biomarker Platforms' deliverables in clinical studies, for the supported assay measures (Pharmacokinetics, Immunogenicity including ADA and NAb, PD Biomarkers, Diagnostic Biomarkers, and Exploratory Biomarkers), from study start-up to regulatory submission.
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Assess and perform statistical analysis of the chemical kinetics data, pharmacological data like Pharmacokinetics and pharmacodynamics data of drug candidates (chemical compounds) on an adhoc basis.
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PhD with 5+ years of experience in the field of biopharmaceutics, drug absorption/ pharmacokinetics, PBPK modeling, in-silico platforms and/or drug delivery of small molecules and/or biologics. Developing plans for in-vitro biorelevant measurements (e.g., solubility/dissolution, IDR, permeability, transfer models for oral; in-vitro release methods for long-acting injectables and implants; SCISSOR model for subcutaneous modality) across projects and collaborating with partners (e.g., Materials Science, Analytical Development) to generate input data for modelling in-vivo product performance.
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Provide oversight to the development of Model Informed Drug Development (MIDD) plans, involving planning and execution of quantitative analyses which may include population pharmacokinetics, pharmacokinetics (PK)/pharmacodynamics (PD), exposure response, disease progression modeling, model-based meta-analysis, and decision analysis.
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The scientist will collaborate with biologists and data analysts across diverse therapeutic areas, such as Oncology, Immunology, Infectious Diseases & Vaccines, Neuroscience, and Pharmacokinetics.
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Scientific and technical knowledge around pharmacokinetics, drug metabolism and drug transporters, including enzymology and enzyme kinetics. Ph. D. in Pharmacokinetics, Drug Metabolism, Pharmaceutical Sciences, or other relevant field and a minimum of 8 years of relevant experience in the biopharmaceutical industry, with good understanding of ADME concepts; or.
$156,500 - $232,000 a yearExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Familiarity with pharmacokinetics modeling and simulation datasets and analyses. Experience with at least one other software than SAS (e.g., R, Shiny, Splus, NonMem) This position provides high quality statistical programming analysis and reporting deliverables for global PK modeling and simulation stakeholders Oncology therapeutic area.
Full-timeExpandApply NowActive JobUpdated 23 days ago - UpvoteDownvoteShare Job
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The Workflow and Data Capture (WDC) team of Pharmacokinetics, Drug Metabolism and Bioanalysis (PDMB) in MRL, is seeking a Contract Lab Automation Specialist to support ongoing and new efforts to optimize our data collection and use in inventing new medicines at a cutting-edge automated incubation lab at our West Point (PA) site.
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Requires Bachelors degree in Pharmacy, Statistics or closely related field. Analyze clinical data complying with CDISC standards and by implementing various statistical procedures. Ensure analysis datasets are in compliance with CDISC and submission regulatory requirements.
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The Workflow and Data Capture (WDC) team of Pharmacokinetics, Drug Metabolism and Bioanalysis (PDMB) in MRL, is seeking a DURATION Contract Lab Automation Specialist to support ongoing and new efforts to optimize our data collection and use in inventing new medicines at a cutting-edge automated incubation lab at our West Point (PA) site.
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Working in a dynamic, multidisciplinary environment, the candidate will be part of a team developing mechanistic models to predict in-vivo performance (pharmacokinetics) of sterile drug products (e.g., long-acting injectables, biologics.
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The scientist will evaluate, develop, and optimize computational methods to analyze next-generation sequencing datasets in support of our drug discovery and development programs, and will produce robust bioinformatics pipelines that can be operated on high-performance computing clusters and in the cloud.
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Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:PhD with 5+ years of experience in the field of biopharmaceutics, drug absorption/ pharmacokinetics, PBPK modeling, in-silico platforms and/or drug delivery of small molecules and/or biologicsExperience in biopharmaceutics/drug absorption, related tools (in-vivo, in-vitro, in-silico) and product design and development.
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Taking the foundational knowledge you build; you will be working with cross-functional teams and as part of a research collaboration with the instrument vendor to define strategies for rapid AE-MS method development and applying this to the development of new workflows within Drug Metabolism and Pharmacokinetics (DMPK.
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Lead the planning activities across various scientific lab groups in Biomarker Platforms, for all Biomarker Platforms-owned measures (Pharmacokinetics, Immunogenicity including ADA and NAb, PD Biomarkers, Diagnostic Biomarkers, and Exploratory Biomarkers) to support clinical study milestones.
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pharmacokinetics job in Collegeville, PA
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