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Lead the analytical development activities for early and late late-stage clinical products at CMO/CRO. The Lead of Quality Control and Analytical Development is responsible for managing a team that provides quality oversight in support of clinical and commercial operations and analytical development of early and late-stage clinical products.
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Partner with a team of dedicated and senior Clinical Biomarker scientists on the science and bioanalytical assays for Moderna's early and late phase infectious disease vaccine programs. The Director will work collaboratively across multiple clinical teams to ensure strategy, planning, execution and data delivery of biomarker lab data for early and late phase infectious disease vaccine clinical trials conducted by Moderna.
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Representing Biomarker Development on Cardiovascular and Metabolism early and late Disease Area Decision Boards to identify, develop, and drive cardiovascular and metabolic disease and compound mechanistic biology, and precision medicine approaches for the portfolio.
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Join Takeda as a Scientist – Analytical Development (AD) – Late Stage Development where you will independently lead efforts in development of analytical methods, implementation of evolving scientific technology and influences strategic planning within AD and across Pharmaceutical Sciences to deliver on program strategy and initiatives.
$170,500 a yearFull-timeExpandApply NowActive JobUpdated 17 days ago - UpvoteDownvoteShare Job
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Work collaboratively with the toxicology team and future translational pharmacology and clinical development teams to support the progression of therapies from late discovery through first in human clinical studies integrating DMPK data into the overall drug development strategy.
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We are seeking an enthusiastic and motivated PK Sciences project team representative to develop and implement DMPK and/or clinical pharmacology strategies to support the pursuit of transformative new medicines from early discovery through late clinical development.
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Keywords : senior director, clinical program lead, late-stage clinical development, clinical trials, global, strategy, hematology, lymphoma, oncology, targeted therapies, ADCs, antibody-drug conjugates, program, asset, label extension, life-cycle management, pharma, biotech, biopharma, MD, medical doctor, phase I, phase II, phase III, FDA.
Full-timeRemoteExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Early and late-stage regulatory CMC program/project leadership (Phase I/II and Phase III IND/CTA, MAA/BLA) and experience with non-viral or viral vectors is desirable. Provide regulatory CMC strategic leadership to support the development of early and late-phase gene and cell therapy products for the treatment of genetic diseases.
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3 or more years of experience in late-stage product and process development and market application of small molecule or oligonucleotide therapeutics. 5 or years of experience in analytical assay development, qualification and validation.
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Design and drive negotiations with regulatory agencies globally in preparation for late-phase clinical development and marketing applications. This opportunity will offer you the chance to grow your Regulatory Affairs CMC expertise across a range of disciplines such as nucleic acid therapeutics, lipid-nanoparticle drug delivery, viral delivery systems, and a range of cell therapy products.
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The primary focus of this role is to lead part of the late phase process development/engineering activities for drug substance processes for one of our key cell and gene therapy assets. The Senior Scientist will be responsible for internal process development work, optimizing cell-based bioreactor processes to increase robustness, decrease aseptic risk, increase yields and reduce the cost of goods.
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The Analytical Development- Waltham team is responsible for late-phase to commercial method development, optimization, validation, advance characterization, process development support, regulatory authoring, and control strategy for ADCs. The team works cross-functionally with process development, regulatory, and quality with the Abbvie network and with contract manufacturing organization and contract laboratories.
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This individual will contribute to optimizing and implementing biologically relevant assays to support early through late stage drug development programs using techniques in ligand binding assays (ELISA, MSD, Luminex, Quanterix, ELLA.
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Founded in late 2015, KSQ is a clinical-stage biotech that has rapidly advanced the field of CRISPR-enabled functional genomics, from in vitro cell autonomous screens to more complex genome-scale screens of immune cells in vivo.
Full-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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3+ years of medical safety leadership experience, inclusive of establishing program-level safety strategy, proactive signal detection & evaluation, risk identification & mitigation planning for early and/or late-stage clinical assets, preparation & authoring of periodic safety reports, Risk Management Plans, health authority responses, and supporting NDA/BLA/MAA submissions.
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late shift jobs Company: Trusted Health in Newton, MA
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