Director Clinical Quality jobs in Middlesex, MA
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DIRECTOR, CLINICAL QUALITY ASSURANCE
Provide leadership and operational management for all Dyne Clinical Quality Assurance (CQA) activities to provide assurance of subject protection and data integrity under GCP regulations including Clinical QA audit program develop...
| Company | Biospace |
|---|---|
| Address | Waltham, MA |
| Category | Manufacturing |
| Job type | Full time |
| Date Posted | 2 months ago See detail |
Director, Clinical Quality Assurance
Biospace
Waltham, MA
Provide leadership and operational management for all Dyne Clinical Quality Assurance (CQA) activities to provide assurance of subject protection and data integrity under GCP regulations including Clinical QA audit program develop...
2 months ago seen See more...
- View all Biospace jobs - jobs in Waltham, MA
Director, Clinical Quality Assurance
Dyne Therapeutics
Waltham, MA
Provide leadership and operational management for all Dyne Clinical Quality Assurance (CQA) activities to provide assurance of subject protection and data integrity under GCP regulations including Clinical QA audit program develop...
2 months ago seen See more...
- View all Dyne Therapeutics jobs - jobs in Waltham, MA
Director, Clinical Scientist - Imaging Specialist (INTO)
Johnson & Johnson
Cambridge, MA
Provide expert imaging input into the design, set-up, execution, and data review of INTO clinical studies. Develop a standard end to end process for imaging and integrate into wider clinical development procedures. . Participate...
2 days ago seen See more...
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Associate Director, Quality Systems Compliance
Biospace
Cambridge, MA
Accountable for leading day to day QA compliance operation in conformance with Intellias policies and procedures. Responsible for QA oversight as it relates to the QMS throughout the product lifecycle. Lead continuous improvement...
7 days ago seen See more...
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Associate Director, Clinical Scientist
Biospace
Waltham, MA
In collaboration with the Clinical Development Lead, be accountable for the scientific aspects of the design, implementation, and conduct of clinical trials with both internal and external stakeholders (e.g., investigator meeting...
2 weeks ago seen See more...
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Executive Director, Head of Clinical Pharmacology and Pharmacometrics
Biospace
Cambridge, MA
Work vertically and horizontally across Research and Development to ensure robust, innovative, and consistent Clinical Pharmacology and Pharmacometrics strategies across the pipeline from pre-IND through early and late development...
2 weeks ago seen See more...
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Senior Director, Clinical Operations Program Lead
Biospace
Waltham, MA
Leads the development and ongoing refinement of Program level study timelines and scenariosin order to contribute to the CDP, IDP and other high-level strategic plans. Provide rigorous, objective information (operational status...
3 weeks ago seen See more...
- View all Biospace jobs - jobs in Waltham, MA
Associate Director, Clinical Data Analyst
Biospace
Waltham, MA
Coordinate with data management study leads, clinical operations, internal stakeholders and external vendors to map non-EDC data from collection through analysis. Partner with IT, internal functions and external vendors to develo...
3 weeks ago seen See more...
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Associate Director, Clinical Operations Study Lead
Biospace
Waltham, MA
Manage all operational aspects from start-up to close-out activities of studies to assure adherence to timelines, budget and milestones while ensuring compliance applicable SOPs, guidelines and regulations. Develop study level ope...
3 weeks ago seen See more...
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Director, Global Clinical Operations Monitoring Oversight, Therapeutics and Oncology
Biospace
Cambridge, MA
Work closely with the Clinical Operations leadership team to align on priorities and desired outcomes related to Monitoring Oversight strategy in collaboration with centralized functions and Monitoring Oversight visits.. Collabora...
2 weeks ago seen See more...
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Senior Medical Director, Neurosciences, Genetic Medicines Clinical Development Unit
Biospace
Boston, MA
Leads the clinical science function at the Strategic Program Team, represents clinical and experimental science functions at that Team, including Precision Medicine, Imaging and Digital Medicine functions. Contributes to overall P...
2 weeks ago seen See more...
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Executive Director of Clinical Development Data and Digital Health Strategy
Biospace
Cambridge, MA
Strategic Planning & Execution: Develop and execute a comprehensive strategy & roadmap for clinical data, business applications and Digital Health solutions within Clinical Development, enabling the successful execution of Moderna...
3 weeks ago seen See more...
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Clinical Director - Co-Occurring Enhanced Services - New Day
Bay Cove Human Services
Somerville, MA
United States, Massachusetts, Somerville
Case Managers. Care Coordinator. Clinical supervision of all employees of the residence. Clinical supervision of interns. Provide clinical oversight and training to all program staff to improve staff skills related to engaging res...
3 weeks ago seen See more...
Senior Director, Clinical Development
Sarepta Therapeutics
Cambridge, MA
Functioning as the clinical sciences team leader to create and execute an Clinical Development plan that provides strategic priorities and solutions to program challenges. Partner with cross-functional leaders and governance bodie...
4 weeks ago seen See more...
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Assistant Clinical Director II (BCBA)
Vinfen
Somerville, MA
Your job title will be Assistant Clinical Director. You will meet with colleagues twice a week and share and receive support and guidance and mentoring. You will receive support for your professional growth through continuing educ...
3 weeks ago seen See more...
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Director, Clinical Safety Scientist
Biospace
Cambridge, MA
Providing therapeutic area PV support for Modernas developmental and/or marketed products in close collaboration with senior PV, Clinical and Medical personnel.. Contribute to process improvements that will ensure excellence in gl...
a month ago seen See more...
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Senior Director, Clinical Development - Infectious Diseases
Biospace
Cambridge, MA
Provide clinical scientific leadership to the blinded Phase 3 clinical trial team.. Provide medical leadership for cross-functional internal workstreams including pharmacovigilance, biostatistics, clinical operations, and regulato...
a month ago seen See more...
- View all Biospace jobs - jobs in Cambridge, MA
Senior Medical Director, Clinical Science, Marketed Products Development
Biospace
Cambridge, MA
Partner with R&D Marketed Product Project Manager to coordinate R&D function support for assigned products within the R&D MPT. Provide medical and clinical scientific leadership and expertise for assigned products to support other...
a month ago seen See more...
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Associate Director, Quality Engineering, Cell Therapy
Biospace
Devens, MA
Directs the QA oversight of commissioning, qualification, and validation activities required for Cell Therapy manufacturing facility, technology transfer, and product launches. Leads team responsible for QA review and approval and...
a month ago seen See more...
- View all Biospace jobs - jobs in Devens, MA
Associate Director, Quality Product Lead
Biospace
Devens, MA
Serve as the core Quality member of the global Operations team (GO) as the single point of contact for the commercial brand, responsible and accountable to the brand team for overall success against the strategic plan (lifecycle,...
a month ago seen See more...
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Director, Clinical Biomarkers , Infectious Disease
Biospace
Cambridge, MA
Partner with a team of dedicated and senior Clinical Biomarker scientists on the science and bioanalytical assays for Modernas early and late phase Infectious Disease vaccine programs. Collaborate with clinical and research teams...
a month ago seen See more...
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Associate Director, Quality Engineering, Cell Therapy
Biospace
Devens, MA
Directs the QA oversight of commissioning, qualification, and validation activities required for Cell Therapy manufacturing facility, technology transfer, and product launches. Leads team responsible for QA review and approval and...
a month ago seen See more...
- View all Biospace jobs - jobs in Devens, MA
Associate Director, Quality Systems
Viridian Therapeutics, Inc
Waltham, MA
$131K - $166K a year
Responsible for the oversight, implementation, and maintenance of Viridians Quality Management System (QMS), including but not limited toDeviations.CAPA.Change Control.Quality Risk Management.Quality Management Review Coordinati...
2 months ago seen See more...
Senior Director, Clinical Pharmacology
Biospace
Waltham, MA
Lead the Clinical Pharmacology function and strategy, with a vision to create scientifically sound, innovative, and efficient programs that meet regulatory requirements, as well as corporate and R&D program goals, enabling advance...
2 months ago seen See more...
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Associate Director, Quality Operations - Vaccines
Sanofi
Waltham, MA
Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team member(s). Assist in the development and maturation of strategic pla...
2 months ago seen See more...
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Medical Director, Clinical Development
Biospace
Boston, MA
Provide oversight and leadership of clinical program including planning, execution, and completion of clinical trials according to all applicable regulations and guidance, ICH/GCP, and Entrada SOPs. Collaborate closely with intern...
a month ago seen See more...
- View all Biospace jobs - jobs in Boston, MA
Director, Quality Control
Verve Therapeutics, Inc.
Boston, MA
$110K - $139K a year
Responsible for the oversight of all QC activities at GMP vendors (eg, CMOs, test sites). Manage a team responsible for QC operations, method validation and technical transfer, and stability at CDMOs and contract laboratories. Par...
2 months ago seen See more...
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Associate Director, Quality Product Complaints / Recalls
Vertex Pharmaceuticals Incorporated
Boston, MA
Responsible for all activities associated with the product complaint process, including reconciliation, training, complaint sample management, triage, trending, and SOP management, etc. Supports all activities associated with the...
2 months ago seen See more...
Associate Director, Quality Assurance Information Systems Management - R&D
Vertex Pharmaceuticals Incorporated
Boston, MA
Advance deeper understanding of GxP regulations (GxP predicate rules) to ensure appropriate phase-appropriate systems life cycle management and oversight. Define and adopt emerging techniques of software testing and deployment bas...
2 months ago seen See more...
Associate Director, CDO Clinical Financial Planning
Biospace
Cambridge, MA
Ensure accuracy of clinical trial budgets and forecasting, including modeling clinical study spend and supporting or developing system to support cost models with related assumptions. Develop, implement, and support financial plan...
a month ago seen See more...
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