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As lead of the Study Core Team the CS will lead via a matrix organization Epidemiology, Biostats, Clinical Operations, Medical/Scientific Affairs, Regional, Pfizer laboratory assay group, and external team members.
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Identifies issues in a timely manner, leads implementation of complex solutions, and/or escalates as appropriate working with Clinical Affairs Lead, Clinical Epidemiologist/Medical/Scientific Affairs Lead and Partner representatives.
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In collaboration with Scientific Affairs (SA) Biostatistics group and Clinical Affairs (CA) Operations, the CS is responsible for execution and project management of their studies.
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The CS also has a strategic role in partnership with Medical/Scientific Affairs to develop operating plans and study strategies in support of the Clinical Development and Life Cycle plans.
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Gather and report internally, medical and clinical insights that contribute to enhancement of important medical positions, plans, future research and development efforts; and identify unmet needsIdentifies opportunities for scientific growth and generation of medical evidence in support and/or expansion of therapies and execution of mutual interest initiatives such as research and continuing medical education (CME.
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Lead the execution of global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in Research and Development, Regulatory Affairs, and Clinical Development.
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Work closely with the Head of Scientific Affairs & Strategic Partnerships and Scientific Affairs team to produce rapid, thoughtful responses to content-related requests from across Pfizer Oncology (CSO, Medical strategy, BoD , Investor Relations, colleagues, etc.
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ROLE SUMMARYBring strong scientific and communication skills, along with industry knowledge, to support Head of Scientific Affairs & Strategic Partnerships and Pfizer Oncology Leadership Team (LT) in providing senior-level scientific, strategic and operational support with creation and communication of a compelling scientific narrative for external (e.g. investor, healthcare professionals – HCPs) and internal (Board of Directors - BoD) audiences.
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The Postdoctoral Clinical Research Fellows is a 12-month position designed to assist in the research at the Advent Health Research Institute (FHRI) and participates in Industry/National Institute of Health (NIH)/Pharmaceutical and government sponsored and investigator-initiated research that supports the FHRI scientific research plan.
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Supporting the Director of Global Scientific Affairs, in conjunction with the Sr. Manager and Project Manager in Global Scientific Affairs, with KOL management as it relates to investigator-sponsored studies (ISS) and/or collaborative research studies (CRS.
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A scientific degree with directly relevant professional experience in small molecule product development, global CMC regulatory affairs, and CMC technical areas of at least 12 years with a BA/BS or 10 years with an MA/MS, PhD, PharmD, or MD.
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Objective / Purpose: 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 and as the Head of the Pathology team supporting nonclinical, clinical and exploratory pathology/IHC biomarkers to achieve proof-of-mechanism/concept and inform decision-making for programs across therapeutic areas and modalities.
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Scientific/Regulatory experience, particularly in the areas of procurement contracts for clinical studies, bioanalytical, and regulatory services is highly recommended. To manage the strategic sourcing of materials and services for British American Tobacco / Reynolds American through the development of innovative and sustainable sourcing strategies to deliver a significant competitive advantage for the company.
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Job Description: Job Title: Research Associate-Scientific Location: San Diego, CA, % on-site, lab-based role. - Basic molecular biology skills (PCR especially; familiarity with library prep preferred) - Proficient in laboratory math (dilutions, cell count-based plating) The Oncology Discovery team at the Oncogenesis Thematic Research Center is seeking a Research Associate to support our drug discovery and characterization efforts.
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The postdoctoral fellow will be responsible for publishing research findings in scientific journals and presenting their work in scientific meetings. Nola Hylton, PhD (Professor, Department of Radiology and Biomedical Imaging, Director, Breast Imaging Research Program, University of California, San Francisco.
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clinical research scientific affairs jobs Company: Regeneron Pharmaceuticals Inc
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