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The Principal Toxicologist will be responsible for the design and execution of nonclinical development toxicology studies conducted externally, interpretation and communication of the toxicology data/reports to support drug development decisions, and for summarizing and writing regulatory submissions.
Full-timeExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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Broad understanding of functional areas of drug development, including preclinical, regulatory, pharmacovigilance, drug supply, data sciences (data management, biostatistics, programming), and clinical operations (including site selection, study start-up, study conduct, and finalization.
$207,255 - $250,000 a yearFull-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Provides oversight of case processing activities for the Xenon clinical development program and serves as safety data management subject matter expert (SME) on regulations and best practices for conventions and handling of safety data in Xenon’s global safety database (GSDB.
$210,000 - $239,500 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Advanced understanding and experience with all functions of the data management lifecycle including data governance, data architecture, data integration, metadata management, data development, data quality management, data administration, security & operations, data stewardship and master data management.
Full-timeExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
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We are using models early to fail less often, executing clinical trials to add valuation to the company, and generating fit-for-purpose data to feed back into Valo’s Opal Computational Platform as we reinvent drug discovery and development from the ground up.
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Direct the planning and implementation of process development, scale-up, technology transfer, and validation efforts in drug substance manufacturing, ensuring strategic alignment and operational excellence.
Full-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Reporting to the Associate Director, Drug Safety and Pharmacovigilance Compliance and Operations, you will play a pivotal role in drug safety activities, supporting records management and compliance across the clinical development and marketing programs.
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Provides ad-hoc programming support to Clinical Operations, Data Management, Statistical Programming, Biostatistics, Drug Safety, Clinical Science, Medical Writing and Drug Safety to ensure rapid access to clinical study data for data cleaning/validation, SAS listings review, TLF, dry runs, etc.
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A market leader in automated bio sample management solutions and genomic services across areas such as drug development, clinical and advanced cell therapies for the industry's top pharmaceutical, biotech, academic and healthcare institutions globally.
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Seeking a Scientist, RNA Analytics to support analytical method development and testing of mRNA and gRNA oligonucleotide drug substance and drug product across all stages of development.
Full-timeExpandApply NowActive JobUpdated 6+ months ago - UpvoteDownvoteShare Job
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Experience with Statistical analysis tools in Python and R as well as data science app development (R shiny/Streamlit). Knowledge of best practices in software engineering for reproducibility and data management skillsAbility to work in and adapt to a fast-paced environment Preferred Qualifications: Experience with protein co-evolution analysisExperience with NGS and bioinformatics toolsExperience with agile methodologies.
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Familiarity with best practices for software development (version control, file management, organization). Proficiency in Python for data science and image processing (e.g., TensorFlow, PyTorch, scikit-image, OpenCV, pandas.
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Collaborate with the Project Management and CMC teams and related functions, including discovery, non-clinical development, Formulation, Analytical Development, QA, and CMC Regulatory Affairs.
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Job Overview: This position is well-suited for a Medical Director with substantial expertise in drug development and safety, providing a unique opportunity to strategize the implementation of safety surveillance for clinical trials, oversee the management of safety signals, take charge of cross-functional teams, and contribute to the development of regulatory safety deliverables.
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Strong knowledge of pharmacokinetics and pharmacodynamics principles, immunogenicity, modelling and simulation, Model-Informed Drug Development, ADME Concepts, and regulatory clinical pharmacology requirements to support clinical development and regulatory submission.
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data management drug development jobs Title: clinical scientist in Cambridge, MA
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