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The Clinical Assistant would assist in building and providing orthotic and prosthetic devices to address their patients’ needs under the supervision of a Certified Orthotist and/or Certified Prosthetist.
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They will support programs by leading efforts on clinical PK, nonclinical PK, DMPK, ADME, PD and ensuring optimal doses and dosing regimens. Serve as the subject matter expert on cross-functional teams to lead projects, direct GLP bioanalytical validations and sample analysis across all nonclinical and clinical pharmacology development.
ExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Overview Working in a fast-paced, high volume, dynamic environment, the Clinical Authorization Specialist will bring clinical expertise to the prior authorization and appeals processes and serve as a liaison and patient advocate between Dana Farber Cancer Institute and various health plans.
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Internal Stakeholders – Development management, BGD management, Novo Nordisk Quality, Clinical Development staff worldwide including line management, Development and support functions in all locations (HQ in Denmark, GBS Bangalore in India, Clinical Outsourcing Management, NNI & BGD in North America), CMRs and GCP Audits.
Full-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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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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The Director of DMPK/Clinical Pharmacology will design and implement DMPK/clinical pharmacology strategies to support preclinical/clinical drug development. Author and oversee DMPK/clinical pharmacology related sections of health authority communication documents including regulatory meeting briefing documents, IB, pediatric investigational plans (PIP) and popPK modeling/simulation reports.
Full-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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These conditions include diabetes, thyroid, parathyroid, adrenal and pituitary diseases; calcium and metabolic bone disorders; male and female reproductive and sexual health; and transgender hormone management.
Full-timeExpandApply NowActive JobUpdated 4 months ago - UpvoteDownvoteShare Job
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PhD, PharmD, or equivalent training in pharmacokinetics, pharmaceutical sciences, or related disciplines with at least 10 years of bio/pharmaceutical industry drug development experience in Clinical Pharmacology.
Full-timeExpandApply NowActive JobUpdated 26 days ago - UpvoteDownvoteShare Job
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And respond to regulatory inquiries related to DMPK, PK/PD, and clinical pharmacology. Ensure that appropriate PK, PD and PK/PD data analyses (including population PK, PK/PD modeling and simulation) are conducted for each study/program while adhering to timelines and budgets to insure prompt and accurate execution of deliverables from clinical pharmacology studies and programs.
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Provide oversight for DMPK/clinical pharmacology related sample management activities including management of BA CROs. You will collaborate with your colleagues in DMPK, biology, preclinical safety, clinical development, clinical operations, translational medicine and biostatistics to deliver high-quality deliverables following selection of a development candidate through clinical proof-of-concept.
Full-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Act as the lead clinical pharmacologist on clinical pharmacology study teams to support clinical development: independently lead the design, protocol development, execution, analysis, and reporting of clinical pharmacology studies (e.g., food effect, BA/BE, human ADME, drug interactions, renal and hepatic impairment, etc.
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Oversee the development and testing of clinical databases and data cleaning procedures, utilizing Medidata Rave/Veeva, and enforce data integrity through comprehensive documentation and quality control.
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The Clinical Laboratory Scientist I performs high complexity laboratory testing for both research and clinical diagnostics in Quanterix’ Clinical Laboratory Improvement Amendments (CLIA) certified Accelerator Laboratory.
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The role of the Clinical Documentation Integrity (CDI) Specialist III is responsible for concurrent and retrospect review and analysis of the medical record to improve overall quality and completeness of clinical documentation.
Full-timeExpandApply NowActive JobUpdated 21 days ago - UpvoteDownvoteShare Job
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The ideal candidate will have a strong knowledge of best practices in Clinical Pharmacology and Pharmacometrics, extensive experience in designing and executing clinical pharmacology studies, and a demonstrated ability to make data-driven decisions based on preclinical and clinical information.
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transgender clinical jobs in Lexington, MA
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