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The scientist in this role will establish a preclinical immunoscience focused Quantitative Systems Pharmacology (QSP) capability to support discovery and early drug development efforts.
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Areas of expertise include genomics, epigenetics, drug resistance, stem cell biology, drug discovery, diagnostics and biomarker development, and pharmacology. The CDI hosts a variety of drug development programs including several prominent NIH sponsored national centers of excellence focused on developing novel anti-infectives against high-threat drug resistant bacterial pathogens and pandemic viruses.
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Demonstrated technical and scientific knowledge of pharmacokinetics, pharmacometrics, formulation development and biopharmaceutics, bioanalytical method development and validation and clinical pharmacology a discipline to facilitate clinical development of drug candidates or in the assessment of business development opportunities.
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Support the CMO in development of program strategy for clinical and translational development by planning and tracking activities in biomarker strategy, translational endpoints, clinical planning and operations, pharmacology, and drug supply.
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The candidate will be expected to collaborate with Medicinal Chemistry and Pharmacology to develop and implement studies vital to address key program DMPK issues and successfully advance research compounds into development.
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With prior successful leadership in small molecule and/or peptide chemistry programs from Hit Identification to Development Candidate nomination is essential, you will be a subject matter expert in at least one of the following: pharmacology, assay development, cell and molecular biology or protein biochemistry to help support the growth and evolution of our platform as well as the Boston-based, early discovery team.
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They will interact daily with our data science and computational group for interpretation and design, our biology and pharmacology group to develop assay workflows for in vivo translation, and our chemistry group to push the boundaries of what is possible with parallel chemistry and library syntheses.
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The Department’s 18 divisions include Academic General Pediatrics, Child Development & Community Health; Allergy, Immunology, and Rheumatology; Cardiology; Dermatology; Dysmorphology; Emergency Medicine; Endocrinology; Gastroenterology; Genetics; Genome Information Sciences; Hospital Medicine; Infectious Diseases; Neonatology; Nephrology; Pharmacology & Drug Discovery; Rehabilitation Medicine; and Respiratory Medicine.
$25.75 - $30.72 an hourFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Senior Director, Drug Safety & Pharmacovigilance will be responsible for building and leading the safety and pharmacovigilance efforts for the Clinical Development organization. Proactively evaluate the clinical implications of safety data from pre-clinical studies, clinical studies, literature and other information sources to predict / establish the safety profile of compounds in clinical development, including employing expert groups and methodologies, Safety Science, Informatics expertise, modeling and simulation to manage the risk to patients, including close interactions with clinical pharmacology.
$305,000 - $362,000 a yearExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Demonstrate a strong track record in early clinical drug development, including the principles of clinical pharmacology, biomarkers of target engagement, experimental medicine platforms, early clinical trial designs and conduct, and operational understanding for implementation.
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The department is part of the College of Pharmacy and University health sciences, which house nationally and internationally acclaimed programs in the areas of biochemistry, neuroscience, pharmacology, virology, immunology, cancer biology, structural biology, and drug delivery.
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Develop and implement new clinical pharmacology tools and technologies to drive efficient drug development. FibroGen recently expanded its research and development portfolio to include antibody-drug conjugate (ADC) and immuno-oncology product candidates for the treatment of solid tumors.
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Provide thorough understanding of pharmacokinetics, pharmacology, toxicology, drug design, use of in silico tools, ability to interpret in vivo results, drug discovery process, purification techniques, and ability to analyze target compound spectra obtained by analytical instruments to characterize compounds such as nuclear magnetic resonance (NMR), infrared spectrometry (IR), mass spectrometry (MS), and elemental analysis.
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This position will work in close partnership with colleagues in Clinical Pharmacology, Biostatistics, Nonclinical Development, Bioanalysis, and Biometrics, as well as with external vendors and partners creating an aligned, quantitative framework to impact strategies and decisions on drug development.
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Successful candidate will have a strong understanding of the drug development process from preclinical pharmacology through to regulatory approval and the principles, concepts, practices, and standards of pharmaceutical program management.
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