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Lead and/or contribute to clinical asset biomarker strategy within early and late-stage clinical development antibody drug conjugate (ADC) programs to generate data that informs on target engagement, pharmacodynamics, mechanism of action and patient selection.
$217,350 a yearFull-timeExpandApply NowActive JobUpdated 21 days ago - UpvoteDownvoteShare Job
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Demonstrated experience in (and understanding of) oncology drug development especially in Early Development; familiarity with related disciplines (biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences.
$269,400 a yearFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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This role requires knowledge of the digital health, neuroimaging or AI diagnostics landscape, a sophisticated analytics background, and an understanding of drug development and regulatory engagement.
$244,950 a yearFull-timeExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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Demonstrated broad translational and clinical development expertise and experience exemplified by at least 10 years international drug development experience (early and late), with emphasis on Pharmacometrics.
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Essential Skills/Experience:·Significant demonstrated expertise within the field of modeling and simulation including PK, PKPD and statistics. International scientific reputation gained from scientific publishing in the field on pharmacometrics.
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Key member of Project Development Teams, collaborate and partner closely with CMC project management, drug substance SMEs, DMPK/toxicology, clinical operations, regulatory and quality. Act as key product SME for the successful execution of technology transfer of drug product processes to manufacturing site(s), providing technical input/insights to the CDMOs.
Full-timeExpandApply NowActive JobUpdated 24 days ago - UpvoteDownvoteShare Job
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Must have cultivated an appropriate attitude to deal with the challenges of drug development and experienced in regulatory interactions. Familiarity with DMPK assays (e.g. enzyme inhibition, induction, metabolite identification, MIST analysis, transporter assays etc.
Full-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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The drug product team is also investing in building new platforms to support complex formulations such as lipid nanoparticles, Antibody Drug Conjugates and AAV and other non-viral vector delivery.
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Experience and extensive working knowledge of MedDRA, WHO-DRUG, and proprietary safety databases Knowledge of FDA and EU regulations and ICH guidelines. Reporting to the Head of Pharmacovigilance (PV), the Senior Director of PV Operations role will have direct oversight of vendor(s) conducting PV operational activities and play a key role in the overall safety operational strategy and safety reporting for all Leap products.
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Senior Director, Drug Substance Position Summary Reporting to the VP, Head of CMC Development, the Senior Director, Drug Substance will be responsible for leading the drug substance team in development and manufacturing as part of PepGen ́s CMC team.
Full-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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In addition, we are proud of the leading-edge science coming out of our discovery labs, including early-stage research programs that leverage our extensive ion channel expertise and drug discovery capabilities to identify validated drug targets and develop new product candidates.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Demonstrated success in program management and strategic planning within a drug development context, from preclinical through late-stage clinical development to launch. Strong working knowledge of the drug development process, including advancing product candidates through the various phases of development and supporting regulatory filings.
Full-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Drive and deliver optimized informatics algorithms and workflows to expedite drug discovery pipelines for a broad portfolio of modalities, such as peptides, antibody-drug conjugates, and targeted protein degraders.
$290,900 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Comprehensive understanding of database and dictionary structures (e.g., MedDRA, WHO DRUG) Deep understanding of drug development, study conduct processes, GCP and regulations related clinical data management as well as ICH guidelines, FDA/EU regulations.
Full-timeExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Psivant Therapeutics is accelerating drug discovery and creating better therapeutics through a computation-first molecular design paradigm that leverages best-in-class methods and technologies arising from decades of research and innovation.
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drug job Title: director in Watertown, MA
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