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Minimum of 7 years of experience working in CMC analytical development area for active pharmaceutical ingredients and drug products under cGMP's. Local CMC program oversight related to analytical development, testing, and characterization, including management of milestone and risk reporting locally and globally; provide training to AD functional representatives.
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We are seeking a Director, Pharmacovigilance and Drug Safety (Operations & Compliance) to join our team. 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.
$239,500 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Hold mentoring session with ADRs and provide guidance and suggestions for program management including CMC development strategy, regulatory submission strategy, quality/analytical control strategy, and specification justification strategy (Mentoring, training and coaching of ADRs.
$234,300 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Associate Director, Commercial Analytics and Operations. Manage the commercial data warehouse requirements and master data management plan for timely, complete, and accurate reporting and analytics.
$194,856 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Global CMC program oversight of PS with management of all project-related analytical topics, development requirements and program milestones including global reporting. Works with senior management to develop and set vision and direction of departmental activities (operational processes) and infrastructure, including but not limited to establishing and driving line function strategies, program managements, resources, and budgets (Departmental operations.
$234,300 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Reporting to the Sr. Director, Global Quality Assurance, the Director, Global Quality Assurance, Technical Operations will provide quality oversight of Contract Development & Manufacturing Organizations (CDMOs) involved in the production of cell banks, drug substance, drug product, and finished drug product, on behalf of Zenas BioPharma, to supply clinical trials and future commercial product to all markets.
Full-timeExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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Responsible for leadership of Clinical Program and Trial Management, Clinical Supply Chain, Data Management and Study Start-up, and execution of all clinical programs supporting Clinical Development within the R&D organization.
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Proactively Manage Risk: Develop and execute operational risk management strategies in collaboration with the Sr. Director of Clinical Development. Domain expertise in oncology drug development, with a preference for experience in early-stage clinical trials.
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Oversee the collection, analysis and interpretation of clinical trial data, working closely with Clinical Development, Biostatistics and Data Management teams to ensure data accuracy and integrity.
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The Director, Clinical Operations is a leadership role responsible for overseeing and managing all aspects of clinical operations for a high priority immunology program. Collaborate cross functionally with internal teams, including Clinical Development, Regulatory Affairs, Biostatistics, Translational Medicine and Program Leadership to ensure alignment on clinical trial objectives and milestones.
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Demonstrated success in study and/or program management and strategic planning within a drug development context, from preclinical through clinical stages. We are actively seeking an Executive Director of Portfolio Operations to champion a trusted single source of truth across our entire portfolio and a sophisticated study, program and portfolio-level reporting, analytics and insights infrastructure to inform decision-making across all levels.
Full-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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The Director, Clinical Operations is a leadership role responsible for overseeing and managing all aspects of clinical operations for a high priority immunology program, KT-621. Contribute to the preparation and review of clinical study documents including the Investigator Brochure, Investigational New Drug Applications (IND), study protocols, clinical study reports, applicable sections of New Drug Applications (NDA) and or Marketing Authorization Application (MAA), updates to the IND, NDA and other safety reports.
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Provide operational expertise and strategic input into the development of Clinical Development Plans (CDP), supporting the overall clinical strategy for the program. 10+ years of experience in clinical operations within the pharmaceutical or biotechnology industry.
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Publicly Traded Biopharmaceutical company in Watertown, MA is expanding for their high profile clinical development trials. This individual possesses clinical operations expertise with a track record of success, working with peers and stakeholders across multiple disciplines to drive programs with multiple studies and indications through all phases of clinical trials (Phase I-III.
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The Director, Strategic Project Management - Clinical Operations is a pivotal role that offers strategic project management expertise to support the Clinical Operations team.
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operations management drug development jobs Title: director operations in Cambridge, MA
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