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Perform integrative analyses of multi-omics data from clinical trials and research cohorts, including genomics, transcriptomics, proteomics, and imaging, to identify biomarkers related to treatment mechanism and response, and potential therapeutic targets.
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Derive novel prognostic and predictive signatures using statistical and machine learning methods to guide patient stratification and biomarker selection in clinical trials. Collaborate with translational scientists and clinicians to design and execute data analysis strategies that address key clinical oncology research questions.
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The qualified candidate will report to the Head of Clinical Data Science and is expected to have the following responsibilities:· Perform integrative analyses of multi-omics data from clinical trials and research cohorts, including genomics, transcriptomics, proteomics, and imaging, to identify biomarkers related to treatment mechanism and response, and potential therapeutic targets.
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Excellent understanding of the business processes, GCP standards and software used in clinical trials, outcomes research and real-world evidence generation. The trials also involve real world evidence generation, patient reported outcomes (PROs) and analysis of complex big data sets.
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These tools allow us to interrogate tumor immunology with a unique "build to understand" mentality and to provide the tools to springboard to academic phase I clinical trials at UCSF. The selected candidate will perform laboratory and investigative procedures by conducting a variety of experimental techniques such as molecular cloning, cell culture (cell lines and primary cells), flow cytometry, CRISPR gene editing, and analysis of mouse tumor models.
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As a Digital Biomarker Lead you will be overseeing aspect of sensor-related research, from benchtop experiments to oversight of technical validation in large-scale clinical trials. This innovative position bridges the gap between traditional biomarkers and cutting-edge digital technologies, driving the development and validation of novel digital endpoints for clinical trials.
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Successfully manage CROs and establish relationships to develop biomarker assays, monitor assay qualification/validation at CROs, as well as bioanalytical/biomarker testing in the clinical trials.
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The Associate Director of Quantitative Science is a self-sufficient and high-impact position that focuses on supporting the statistical and data science needs in the risk-based monitoring (RBM) of clinical trials, serving in roles such as CSM lead (CSM: Centralized Statistical Monitoring), while also support other activities such as preclinical studies, biomarkers, application of AI/ML and development of analysis applications.
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Experience in Clinical Trials Registration, Data Safety Monitoring Boards, JHU procurement and vendor relations. The Center requires a Senior Program Officer II (SPOII) with international expertise to manage the Center research, training, and translation strategy, and oversee sub-studies including cross national research and data analysis, translation of research findings for advocacy and policy/program impact, collaboration with nongovernmental organizations (NGOs), and donors.
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Reporting directly to the Disease Team Project Manager, the Clinical Research Coordinator I is responsible for coordinating and managing clinical trials including providing all aspects of protocol management, including screening for patient eligibility, data collection and analysis, ensuring protocol compliance, adverse drug reaction reports, monitoring patient treatment and toxicities, laboratory and specimen submission, and maintenance of accurate and complete clinical research files.
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Essential Functions Provide scientific, regulatory, and compliance oversight to the Biologics Analytical Technologies group responsible for analytical methods developed, optimized and performed to support preclinical, phase I through phase III clinical trials including raw material testing; in process, characterization and release bulk drug substance testing; and stability study testing for BDS and DP. Also, supports Phase III/licensure by technology transfer to external partners.
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As they expand their operations, working towards further clinical trials and ultimate commercialization, they're looking for a hands-on Senior Process Engineer to help manage their primary lab-based activities syntheses, manufacturing, characterization, process optimization and scaleup.
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Execute sample testing and analysis for toxicology and clinical trials. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world.
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We are seeking an exceptional Senior Principal Statistician with strong statistical and computational skills to support multiple complex clinical trials in Oncology and COVID. The Senior Principal Statistician is responsible for leading and performing biostatistics and statistical programming activities in these trials, which may be Phase I, II and III pharmaceutical trials and medical device trials evaluating new biomarkers and/or therapeutics.
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Serve as the SME for important toxicology/Safety topics in areas such as safety biomarker analysis, genetic, endocrine, reproductive toxicology, applications of scientific methods to delineate appropriate mode-of-actions on emerging safety issues and the assessment of human relevance of the nonclinical findings in support of the planned and ongoing clinical trials.
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