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The DMPK group works in close partnership with disciplines such as medicinal chemistry, pharmacology, toxicology, pharmaceutical sciences, clinical pharmacology and regulatory to optimize leads, select clinical candidates, conduct preclinical development studies, support clinical evaluation and contribute to IND and NDA filings.
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Utilize preclinical ADME, pharmacology, and pharmacodynamic data to develop predictions for human efficacious dose. Develop and validate preclinical PK/PD/Biomarker/Efficacy models to elucidate quantitative PK/PD relationships.
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Interface broadly with key functions including Discovery Sciences, Preclinical Pharmacology, Pharmaceutical Sciences, Toxicology, Translational Biomarkers, Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs, and late stage Clinical Research throughout sites in the USA, UK and Belgium.
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Bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology) math, engineering, or medical fields is preferred. Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.
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PhD, PharmD, and/or MD in relevant scientific field such as pharmacokinetics, pharmacometrics, clinical pharmacology, pharmaceutical sciences, bioengineering, biostatistics. Experience in pharmacokinetics, pharmacometrics, clinical pharmacology, population PK modeling, physiological based pharmacokinetic modeling, exposure-response modeling, and clinical trial simulation.
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Collaborate with subject matter experts in Clinical Research, DMPK, Regulatory, CMC, Toxicology, Pharmacology to progress clinical compounds from preclinical through all phases of clinical development, in a program team.
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Candidates with innovative research programs in drug design and discovery, pharmacology and toxicology, novel biological targets, novel small molecule labeling, and cheminformatics or computational chemistry are encouraged to apply, as are those with experience with preclinical or clinical trials of their novel compounds.
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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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O Ph. D. in immunology, oncology, pharmacology, cell biology or related field, o Technical and strategic leadership spanning preclinical discovery and translational research, with a focus on.
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Perform preclinical candidate screening of siRNAs leading to lead compound selection via combined in vitro and in vivo assays, working with or supported by cross-disciplinary groups, including chemistry, bioassay, histology, and in vivo pharmacology, and/or CROs.
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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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The Medical Director, Clinical Development will collaborate with multidisciplinary functional representatives including Clinical Operations for study design and implementation, Pharmacovigilance, Regulatory Affairs, Medical Affairs, Biostats, Quality Assurance, Program management, Preclinical Development and other functions to ensure aligned design and execution of all programs.
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Essential FunctionsDirects, leads and manages preclinical pharmacology projects and studies as determined by the needs of the organisation and in accordance with the appropriate Jazz, CRO or researchers SOPs, relevant regulatory guidelines, legislation, best industry and ethical practices, and departmental processes as required per study.
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The position requires direct management of pharmacology scientists as well as serving as project team leader for 1-2 preclinical stage drug discovery teams. Familiarity with other drug discovery disciplines, including chemistry, DMPK, proteomics, lipidomics, toxicology and clinical pharmacology, and the ability to confidently lead or participate in technically complex cross-functional discussions.
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Job Description Primary responsibility is to advance multiple research projects from Lead Optimization through Candidate Selection stages through effective leadership of matrixed, multi-disciplinary teams with membership from discovery, precision medicine, preclinical safety and safety pharmacology, DMPK-BA, CMC, clinical development, and others.
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