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The Associate Director, Clinical Data Analyst, has a critical role in the delivery of high-quality external data across Dyne's development pipeline by proactively identifying, measuring, and mitigating risk prior to acquisition of non-electronic data capture (EDC) data.
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Join us as a Director, Clinical Pathology in our Cambridge, MA location. The Bioanalytical and Biomarker Sciences and Technologies (BST) department at Takeda is seeking a strong scientific and strategic leader to join the group as a clinical pathology expert supporting pathology/IHC biomarkers in clinical development programs across therapeutic areas and modalities.
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Reporting to the VP, Clinical Research Management Dana-Farber Cancer Institute/Dana-Farber/Harvard Cancer Center, the Director will also work closely with the DF/HCC Medical Director for Clinical Trials.
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Reporting to the Head of Clinical Supply Chain, the Associate Director of Clinical Supply Planning will focus on managing and optimizing global supplies to ensure timely availability of clinical supplies for clinical trials.
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Deep knowledge of immuno-oncology biology, biomarker strategies and application to clinical trials. Working with Research Unit biology leads and Precision Medicine Companion Diagnostic leads to ensure alignment of preclinical, clinical biomarker and CDx strategies.
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This role is specifically focused on CMC partnerships in Cell and Gene Therapy in terms of process development, clinical and commercial manufacturing and will require a high level of engagement and collaboration.
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The Clinical Scientist is a Director/Senior Director who will help design and execute the clinical development plan for Affinia’s cardiac and neurology gene therapy pipeline.
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The Director, Bioanalytical Diagnostic Development, will be responsible for defining the global bioanalytical development strategy and leading all activities related to clinical bioassays/diagnostics, from preparations for ‘first in human’ up to registrational studies and post-approval commitments.
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The Psychiatric Nurse Practitioner director is responsible for curriculum development and oversight of the quality of educational outcomes. Psychiatric Nurse Practitioner Program Director.
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The Senior Director of Clinical Pharmacology will provide leadership to the Clinical Pharmacology and Pharmacometrics team and be accountable for the overall strategy for determining the PK, PD, and immunogenicity properties of all programs at Dyne Therapeutics.
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Completion of four (4) units of Clinical Pastoral Education. Completion of two (2) units of Clinical Pastoral Education. Communicates relevant patient information with other disciplines through the use of referral systems, chart entries and other mechanisms in the clinical setting.
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Adhere to preceptor guidelines, provided by the Director of Clinical Education, which include placement objectives and learning outcomes, supervision methodology, attendance policies in line with those of MCPHS, assignments and deliverables, timelines and evaluation criteria.
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Oversee the histopathology work for tissue-based nonclinical and clinical assay development including single and multiplex immunohistochemistry or immunofluorescence, spatial transcriptomics, digital pathology, and pathology-based image analysis.
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Director, CMC Bioconjugation & External Manufacturing Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases.
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PhaseForward Inform, Oracle Clinical and/or other clinical data management software desirable;General software skills: MS Access, MS Word, MS Excel, MS Project, Visio, familiarity with medical coding dictionaries, especially MedDRA and WHODRUG.Experience applying best practices in clinical data management programming in the clinical trial environment, including requirements definition and QC plansKnowledge of GCP and other regulations.
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Title: director clinical Company: Nucleus Healthcare in Waltham, MA
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