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Strong subject matter expertise in immune-oncology, cell therapy drug discovery and development including CMC considerations, CAR design, engineering and armoring strategies, innate immune cells such as NK and gamma delta for the purposes of leading drug development projects from start to the clinic.
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This position is responsible for DMPK characterization and bioanalysis of pipeline compounds as they progress in clinical development. Must have cultivated an appropriate attitude to deal with the challenges of drug development and experienced in regulatory interactions.
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Analytical Skill, Analytical Skill, Analytical Thinking, Chemical Biology, Chemistry, Clinical Trials, Communication, Curiosity, Data, Data Analysis, Design of Experiments (DOE), Detail-Oriented, Drug Development, Drug Discovery Process, Ethics, Gene Therapy, Group Problem Solving, Immunology, Inventory Management, Laboratory, Large Group Presentations, Leading Project Teams, Life Science, Machine Learning (Ml), Medical Research {+ 9 more.
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Prior experience in rare disease drug development is highly desirable. Direct the development and validation of statistical programming code for the analysis and reporting of clinical trial data.
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You will be responsible for working with clinical, cross-functional study teams, and third party vendors/CROs to manage and support drug safety and pharmacovigilance operational activities and deliverables across Tango's clinical development portfolio.
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Lead and manage multiple drug discovery projects, overseeing the entire drug development process from target identification to preclinical development. Deep understanding of the drug discovery process, including target identification, hit-to-lead optimization, and preclinical development.
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AVEO continues to develop FOTIVDA in immuno-oncology combinations in RCC and other indications, and has several other investigational programs in clinical development. Provide PV staffing for each Product Development Team and coach/supervise the staff in the execution of their responsibilities to the team as they pertain to drug safety including protocol input, Investigator Brochure input, annual reports, signal detection and the key safety components of potential NDA/PMA submissions.
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Contribute to the Biomedical Research drug discovery process with the goal of progressing the development of new therapeutic options for patients with chronic kidney diseases. Principal Scientist II, Drug Discovery Kidney Diseases.
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The individual will be responsible for TM and clinical biomarker activities to support drug development programs in multiple diseases in neurology and neuropsychiatry. + Determines appropriate assays and vendors for clinical biomarkers, and manages outsourcing of biomarker assay development and validation partnering with Translational Sciences colleagues when applicable.
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A minimum of 15+ years' experience in pharmacovigilance leadership roles, including Head of Drug Safety/Patient Safety/ Product Safety & Pharmacovigilance for a bio-pharmaceutical/pharmaceutical company (minimum of 5 years), medical monitoring within a global CRO, and/or clinical practice in a relevant therapeutic area.
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The Principal Scientist, Computational Biology leads the development and deployment of computational methods for NGS-based clinical diagnostic assays in our clinical labs. Work closely with bench scientists to develop and optimize new wet-lab protocols in concert with computational biology development efforts.
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We are a market leader in automated bio sample management solutions and genomic services across areas such as drug development, clinical and advanced cell therapies for the industry's top pharmaceutical, biotech, academic and healthcare institutions globally.
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The position involves collaboration with protein science, in-vivo biology, single-cell sequencing, bioinformatics, translational and clinical teams to execute and advance HiFiBiO’s drug discovery and translational research.
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The VP, Non–Clinical Development leads the development and execution of the toxicology profiling of Seaport's drug candidates, including risk assessment /mitigation, development of innovative toxicology strategies, and communication of plans throughout the organization to ensure cross–functional alignment.
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Lead internal process development, optimization and tech transfer of upstream and downstream process development for clinical development pipeline. Lead clinical manufacturing efforts between internal teams and external CDMO’s for clinical development preparing for IND.
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clinical drug development jobs Company: Us Quintiles Inc in Cambridge, MA
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