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The role represents the CPQP function on drug development teams, leads CPQP sub-teams, and owns strategy and delivery on posology for early and late-stage clinical trials while collaborating with clinicians, clinical operations, bioanalytical, biomarker, pharmacovigilance, regulatory and CMC groups.
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Deep knowledge of immuno-oncology biology, biomarker strategies and application to clinical trials. Experience in conducting clinical trials and working as part of a clinical study team and other matrix teams.
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The Clinical Scientist will report to the Head of Clinical Sciences within clinical development and closely interact with the medical director(s) as well as with the biostatistics, regulatory, translational, and discovery/preclinical groups to facilitate execution of early phase studies and development of next phase clinical trials.
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Conducts medical review and interpretation of efficacy and safety data from clinical trials; this may include delivery of top-line report in collaboration with study statistician, and delivery of clinical study report in collaboration with medical writer and accountable for overall quality and timeliness of analysis and reporting.
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Experience with rare disease and/or pediatric trials also preferred. Minimum of 10 years experience in drug development, clinical research and operational strategy experience including responsibility ensuring studies and programs are executed to quality, timelines and budget (at least part of this time in a Biotech/Pharma environment is preferred.
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The Clinical Research Director (CRD), Amlitelimab, Immunology and Inflammation Therapeutic Area is responsible for the development, execution and reporting of clinical trials in support of the registration of a product, directly reporting to the Clinical Lead in charge of the clinical strategy.
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Due Diligence, Business Development and Alliance ProjectsResponsible for evaluation of potential business development opportunities and conduct of due diligence evaluations assessing scientific, medical and development feasibility, evaluating complete or ongoing clinical trials, and regulatory interactions and future development plans.
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Provide Pharmacovigilance support for the clinical trials in conjunction with our PV team. Experience in clinical research, including designing, planning, and monitoring clinical trials.
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Hands-on experience with interpretation of flow cytometry data in clinical trials is required. Experience with analysis of clinical biomarker data on gene expression, multi-plex histology and soluble biomarkers is preferred.
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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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The Director Clinical Development will work hand-in-hand with the VP Clinical Development to implement clinical strategies and operationalize in both programs and clinical trials.
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We are a diverse team of experienced physicians, clinical scientists, and clinical program directors who collaborate to delineate early phase clinical development strategies, design innovative phase I-IIb clinical trials, develop and validate novel surrogate endpoints, and translate novel scientific ideas to proof of concept studies in targeted patient populations.
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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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Experience in immune-oncology or oncology clinical drug development, preferably in a pharmaceutical or biotechnology company, as well as significant knowledge and experience in the design and execution of clinical trials.
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Reporting to the Vice President, Biometrics, the Associate Director of Clinical Data Management will be responsible for leading the clinical data management processes across Tango’s clinical trials.
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trials job Title: clinical director in Boston, MA
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