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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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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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Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data management strategy for the organization.
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The Associate Director, Clinical Scientist is a key member of the Clinical Development team for the planning, conduct, analysis, and reporting of clinical studies. Sound knowledge of principles of clinical data collection and reporting; demonstrated ability to use systems and tools (e.g., EDC systems, Excel, PowerPoint, Veeva CRM) for data collection, analysis and reporting.
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Provides ad-hoc programming support to Clinical Operations, Data Management, Statistical Programming, Biostatistics, Drug Safety, Clinical Science, Medical Writing and Drug Safety to ensure rapid access to clinical study data for data cleaning/validation, SAS listings review, TLF, dry runs, etc.
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The Associate Director, Clinical Data Management is responsible for overseeing the start-up and execution of multiple, complex trials with a CRO and supporting upcoming submissions. Deep understanding of drug development, study conduct processes, GCP and regulations related clinical data management as well as ICH guidelines, FDA/EU regulations.
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Responsible for managing the clinical trial data queries along with the planning and execution of medical coding and SAE reconciliation. The individual will coordinate and manage daily data management and vendor oversight activities for multiple clinical trials to support both the internal project team and the CROs.
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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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As the Director, Clinical Development Scientist (CDS), you will play a key role in designing and execution of the important clinical studies. Collaborating with the clinical study team in site identification and selection and provide assistance with study start-up activities; Participate in the development of clinical study protocol concept sheets and protocols, study operations manuals, and other study essential documents.
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You will have a proficiency in the drug development process, particularly early phase clinical trials, protocol writing and study conduct, data review and reconciliation. At least 3 years of experience in clinical research and/or oncology drug development in pharmaceutical, academic or CRO environment.
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Senior Medical Director, Clinical Development. Serve as Medical Monitor and the Sponsor’s medical representative to multiple vendors and collaborators: CROs, PIs, core laboratories and other organizations involved in the implementation of clinical trials.
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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 Executive Director/VP, Clinical Development is a highly visible role within the organization. This individual will collaborate closely with Clinical Operations, Clinical Pharmacology, Medical and Scientific Affairs and other functions, and externally with Key Opinion Leaders and Investigators, Regulatory Authorities, Patient Advocacy Groups (PAG) and others involved in the scientific and clinical development process.
$290,000 - $330,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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The Director will be responsible for leading global clinical trials in Phases I – III in collaboration with the Head of Clinical Operations. A growing biotechnology company based in Waltham, Massachusetts is looking for an Director, Clinical Operations to join the team.
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Type Direct Hire Salary $1 - $2 / yr ASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENTReporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data management strategy for the organization.
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Title: director clinical in Waltham, Troy, New York
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