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Prior management of contract research organizations (CROs) for clinical biomarker assay development and qualification. Prior experience implementing precision medicine approaches in clinical trials including companion diagnostic (CDx) development experience in liquid-based and tumor tissue-based approaches.
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Laboratory research/Assay development/Automation. A subject matter expert in Immunology, automation and assay development. Qualified candidates must have a broad working knowledge of immunology, with a preferred focus on immune models and immune assay development.
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Extensive working knowledge of biomarker assay development and the ability to critically evaluate emerging technologies in the clinical biomarker space. A successful incumbent would help integrate basic science research, proteomics, genomics and informatics to advance clinical development of therapeutics for autoimmune diseases.
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The Director, Bioanalytical Diagnostic Development, will be responsible for defining the global bioanalytical development strategy and leading all activities related to clinical bioassays/diagnostics, from preparations for ‘first in human’ up to registrational studies and post-approval commitments.
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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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The role represents the CPQP function on drug development teams, leads CPQP sub-teams, and owns strategy and delivery on posology for early and late-stage clinical trials while collaborating with clinicians, clinical operations, bioanalytical, biomarker, pharmacovigilance, regulatory and CMC groups.
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Review and evaluate immunoassay bioanalytical results supplied by external CROs to ensure quality; review GLP and clinical BA assay validation protocols and reports. Support development of regulated and clinical bioanalytical strategies for large molecule drug candidates, and conduct PK, ADA, and biomarker assays internally.
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The Analytical Development Research Associate / Senior Research Associate will support the goals and timelines for the Cell Analytical Development team through timely completion of assay development projects, demonstrate excellent documentation skills.
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What this position is all about : Cellarity is seeking an experienced, talented and highly motivated Director/Sr. Director, Program Management to play a vital role in the company’s efforts to progress small molecule lead candidates through IND and into clinical trials.
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Familiarity with common molecular and cell biology techniques to support ligand characterization (e.g., western blotting, cell culture, assay development, in vitro viability assays) The candidate should enjoy working in a multi-disciplinary team comprised of biologists, translational pharmacologists, medicinal chemists, enzymologists, and DMPK experts working on the development of novel therapeutics.
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Expertise in primary human cell culture, multi-color flow cytometry, multiplex cytokine detection, functional immune cell assays (proliferation, cytotoxicity, chemotaxis) and assay development is essential.
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Solid understanding of bioanalytical and biomarker strategies, applicable regulatory guidance, clinical trials, endpoints and deliverables. Join us as a BST and Clinical Biomarker Lead, Neuroscience, Associate Director in our Cambridge, MA location.
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PepGen is looking for a highly motivated Associate Director or Director level Biomarker scientist who will contribute to the preclinical/clinical development to support and expand their current and future pipeline.
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Deep knowledge of immuno-oncology biology, biomarker strategies and application to clinical trials. Representing Precision Medicine at Medicine Development Teams (MDT) and/or Clinical Matrix Teams (CMT) establishing clear biomarker driven decision-making criteria to enable clinical development.
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Reporting to the Head of Clinical Supply Chain, the Associate Director of Clinical Supply Planning will focus on managing and optimizing global supplies to ensure timely availability of clinical supplies for clinical trials.
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clinical trials assay development jobs Title: director associate in Cambridge, MA
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