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10+ years of research and development experience with drug metabolism, with demonstrated experience designing, executing and/or managing outsourced clinical pharmacology and nonclinical studies; experience in small mid size biotech preferred.
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Collaborate with CRO and academic partners; employ cutting-edge in vitro and in vivo animal and human models to advance drug discovery and development programs up to and including IND filing.
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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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We are seeking a highly motivated and skilled candidate to join Novartis Biomedical Research as a Discovery Postdoctoral Fellow within the Discovery Sciences (DSc) department to work on expanding the scope of covalent drug discovery.
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The successful candidate will have the ability to bring creative/innovative clinical designs to define and apply the most effective approach across Marengo's R&D pipeline while working closely with drug development teams (e.g., drug discovery, immunology, clinical development, clinical operations, regulatory, safety, and pharmacovigilance.
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Solid clinical experience from direct patient care (clinical experience and/or board certification in Oncology, Immunology, Genetics desired) and 10+ years of experience in drug development and in drug safety/pharmacovigilance required.
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Demonstrated scientific knowledge of Pharmaceutical Drug Discovery, CMC, Clinical Development, and Intellectual Property Processes. Proficient in drug development process with familiarity on the chemistry and manufacturing side of drug delivery systems.
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Provides strategic planning, implementation, and management of drug safety activities to support clinical development pipeline. 8+ years’ experience in Drug Safety / Pharmacovigilance in a pharmaceutical or biotech company, CRO or regulatory agency.
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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 candidate will be responsible for formulation and process development activities of oligonucleotide drug product programs to support Biogen's growing pipeline. Biogen is presently looking to fill a Scientist II position within its Anti-Sense Oligonucleotide (ASO) Formulation and Drug Product Development group.
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A minimum of 6 plus years in a drug discovery/early development function including 2 plus years of experience in a lead role overseeing ADME/DMPK strategy of compound development.
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Within the United States research and development (R&D) sites, instructor-led (ILT) and computer-based health, safety, and environment (HSE) learning (CBL) objectives are scheduled, delivered, and tracked through the Sanofi iLearn Learning Management System (LMS.
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The Translational Neuropathology group at Biogen, part of Translational In-Vivo Science in Research, is seeking a highly motivated and talented scientist to join a dynamic team engaged in human disease translational research and drug development.
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The Associate Director of Global Regulatory Affairs Chemistry, Manufacturing, and Controls (GRCMC) Devices and Combination Products will be responsible for leading, developing, and implementing global CMC regulatory strategy related to Alexion's drug/device portfolio, in vitro diagnostics and clinical decision software leading to successful registration and life-cycle management of unique and technologically complex products.
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Veeva's Vault Development Cloud helps organizations eliminate silos and transforms business processes across clinical, regulatory, quality, and drug safety with greater efficiency and compliance.
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drug development jobs Company: Genoskin in Revere, MA
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