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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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PRINCIPAL DUTIES AND RESPONSIBILITIES: Study Start-Up·Oversight of the clinical trials start-up process from receipt of proposal materials, protocol development, IRB submissions, through site(s) activation.
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Analytical Skill, Analytical Skill, Analytical Thinking, Chemical Biology, Chemistry, Clinical Trials, Collaboration, Communication Skills, Curiosity, Data, Data Analysis, Design Of Experiments, Detail-Oriented, Drug Development, Drug Discovery, Ethics, Gene Therapy, Immunology, Inventory Management, Laboratory, Lifesciences, Machine Learning (Ml), Management, Medical Research, Molecular Biology {+ 10 more.
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Work on cross-functional teams with preclinical biology/pharmacology, clinical pharmacology, nonclinical safety assessment, and translational medicine to develop quantitative model-based understanding of both the target biological pathways and novel therapeutic agents.
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Implement a modeling & simulation strategy to assist and accelerate decisions around preclinical study design and interpretation, as well as prediction of first-in-human dose and safety margins for clinical trials.
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This individual will work on multiple trials in Phases 1 through 3 and may also participate in selected projects in the CF clinical development program. The Associate Medical Director will serve as the Medical Lead for Vertex clinical trials in Cystic Fibrosis (CF), working with cross-functional multidisciplinary study teams on clinical trial strategy, design and execution and serving as the primary Medical Monitor responsible for monitoring the safety of enrolled subjects on assigned trials.
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The successful fellow will receive training in developing scientific concepts and related analytical designs with a focus on rehabilitation clinical trials, mixed, methods, hybrid trials, and implementation science to prepare the postdoctoral fellow to contribute significantly to the field of rehabilitation research in MS. *DUTIES AND RESPONSIBILITIES.
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Work with MGB Research Management, Clinical Trials Office (CTO) and Innovation offices to manage lifecycle of research grants and contracts. Maintain working knowledge of federal Human Subjects System (HSS) and Clinical Trials.gov to assist with entry and troubleshooting of clinical trials and human subjects data.
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Hands-on use of data science, machine learning and visualization to challenges faced in drug development including support for design and interpretation of clinical trials. We are a team of experts with a Machine Learning and Data Science backgrounds, solving problems for pharma and clinical trials.
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Responsibilities Develops clinical imaging strategies designed to support the clinical development plans for RLT agents Designs and implements imaging protocols, plans and procedures for clinical studies Provides oversight and guidance for all aspects of Medical Imaging for clinical trials Delivers subject matter expertise regarding advanced imaging techniques (including PET/CT, SPECT, MRI, CT, and other modalities as needed), image evaluation, and dosimetry estimation.
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Our research involves a broad set of projects ranging from microbiome and translational research to clinical trials. Additional responsibilities include working in close contact with gastroenterologists, research staff, clinical staff, Partners’ Institutional Review Board (IRB), and fiscal/legal groups within and outside of Partners, as necessary.
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The Platform fully centralizes RWE, epidemiology, outcomes research, RW-relevant health informatics, and biostatistics talent from global, international markets into one team to drive efficiency through internalized work.
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Experience in and understanding of end-to-end management of clinical trial conduct, the pharmaceutical industry, clinical drug development, clinical trials operations and regulatory components is essential.
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Plan, initiate, execute, and close clinical trials, managing timelines, budgets, and quality standards, and ensuring compliance with GCP and regulatory guidelines. Work closely with Clinical Development, Regulatory Affairs, Medical Affairs, and Data Management teams to align on trial objectives and ensure successful execution.
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As a Quantitative Systems Pharmacology Modeler - Senior Scientist in DMPK & Modeling, you will be empowered to interface between clinical pharmacology, clinical research, nonclinical drug safety, drug discovery, drug metabolism, translational medicine and pharmacovigilance to influence drug development.
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clinical trials work jobs in Jamaica Plain, MA
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