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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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As lead of the Study Core Team the CS will lead via a matrix organization Epidemiology, Biostats, Clinical Operations, Medical/Scientific Affairs, Regional, Pfizer laboratory assay group, and external team members.
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Proven track record in developing and scaling up chemical processes from laboratory scale to kilolab, pilot plant, and commercial plant. Design and execute synthetic processes to produce drug substance for GLP tox and clinical supplies.
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Lead assay development/implementation efforts in clinical biomarker team by partnering with preclinical and clinical biomarker lab teams to understand current assay status and potential vendor or internal laboratory requirements for oncology programs.
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The Director is well-versed in contract clinical manufacturing and effectively delivering client projects in a fast-paced environment. 3+ years of life science laboratory experience, especially cell culture, molecular biology, virology.
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The Quality organization at Mural is dedicated to ensuring compliance and excellence across all research and development activities, encompassing Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practice (GvP), and Good Manufacturing Practice (GMP.
Full-timeExpandApply NowActive JobUpdated 24 days ago - UpvoteDownvoteShare Job
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Strong clinical and scientific background with a good understanding of genetic concepts and molecular biology laboratory techniques. In this role, you will work closely with Clinical Program Management, the ATTR-CM Clinical Development Lead (Senior Medical Director) and R&D Leadership as the medical monitor for Intellia ATTR clinical trials and will be responsible for evaluating data and extracting key insights from ongoing and completed clinical trials.
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Lead clinical data strategy (including external laboratory data) across the C4T portfolio of studies, ensuring the CDM team delivers against time, quality and cost targets. The Senior Director, Clinical Data Management is responsible for leading the C4 Therapeutics, Inc. (C4T) Clinical Data Management (CDM) department.
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The role requires expertise in current Good Manufacturing Practice (cGMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and relevant regulations across multiple jurisdictions.
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Lead and align drug substance process development and manufacturing with clinical trial plans and corporate goals. Extensive knowledge and hands-on experience with laboratory and plant equipment and processes commonly used for synthetic chemistry, including knowledge of radiolabeled synthesis.
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ASSISTANT DIRECTOR FOR CLINICAL MEDICINE , Division of Comparative Medicine (DCM) , to join ten other veterinarians who play a crucial role in delivering the highest standards of animal care, welfare, and collaborative research support.
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5+ years’ experience working in a clinical diagnostic laboratory regulated by CAP/CLIA/NYS and or FDA guidelines. Lead the transfer of R&D assays involving peripheral blood and tissue to the clinical laboratory setting.
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Job Overview: The Senior Director will lead chemical process development and manufacturing, serving as a technical expert, coordinating with external partners for drug substance production, and providing leadership and expertise in equipment and processes for chemical synthesis.
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Responsible for R&D Quality strategy and execution, including quality elements covering Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) and Good Pharmacovigilance Practice (GVP.
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A level of knowledge of technical operations and administration generally acquired through the equivalent of four years of experience in a large clinical laboratory in the capacity of technologist, plus two years of laboratory management experience.
Full-timeExpandApply NowActive JobUpdated 21 days ago
clinical laboratory jobs Title: director in Lexington, MA
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