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The Clinical Research function, as a sub-function of Scientific Affairs, includes planning, coordinating, and overseeing the successful execution of preclinical and clinical research studies and large-scale data collection efforts in partnership with our surgical practice partners.
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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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Cultivate engagements between Danaher and biopharma key opinion leaders (KOLs) in neurology and related disease areas; possess in depth knowledge of biopharma drug pipelines in neurology and anticipate the diagnostic needs of pharma (from Research Use Only (RUO) to Clinical Trial Assay (CTA) to In Vitro Diagnostics (IVD) inclusive of Companion Diagnostics (CDx) and Lab Developed Tests (LDTs.
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Support Danaher Diagnostic Operating Company Medical and Scientific Affairs and Government Affairs organizations on their strategy so that it maximizes patient impact at scale. Prior roles in industry Medical and Scientific Affairs and/or Government Affairs functions a plus.
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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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Reporting to the CSO, Danaher Diagnostics, this position will provide medical/clinical, scientific, and technological insights and related expertise to the Diagnostics Operating Companies (OpCos) in developed economies and high-growth market countries/regions.
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The Medical Director for Molecular Oncology will have responsibility for leading clinical research efforts directed towards developing projects that assess the clinical utility of our somatic and circulating tumor DNA testing platforms and establishing the scientific credibility of our test offerings to outside stakeholders in support of our commercial efforts.
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QUALIFICATIONSA 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. Demonstrated track record in defining innovative CMC regulatory strategies, and implementing at a platform level.
$237,660 - $307,560Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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You will be responsible for providing, scientific leadership, and collaborative working environment to advance the drug candidates from IND through Phase IV. In addition, this position will collaborate with cross-functional stakeholders including in vitro & In vivo pharmacology, clinical biomarkers, DMPK, clinical development and operations, regulatory, CMC, and medical affairs.
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Professional (Non-Clinical), Research and Scientific. This position is housed in the Clinical Research Support Office (CRSO), a centralized clinical trial management office in the UCSF Helen Diller Family Comprehensive Cancer Center (HDFCCC), which provides project management and clinical research coordinator staff, and regulatory services for oncology related clinical trials.
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The Prostate Cancer Radiopharmaceutical Senior Medical Science Liaison (MSL) is a key member of Global Medical Affairs, communicating scientific, clinical and technical information within the medical community, developing and maintaining strong collaborative relationships with Key Opinion Leaders and serving as a therapeutic and radiopharmaceutical expert with internal audiences.
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The MSL demonstrates expertise and extensive knowledge in the field of oncology, radiopharmaceuticals, medical imaging trends, clinical trials and scientific activities within the oncology therapeutic and medical imaging arena.
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Has leadership and management responsibility for overseeing the school's financial and budget administration including budgetary targets; human resources/workforce planning and training including recruitment and development program; information technology; office management; faculty affairs; student affairs; scientific/research affairs; clinical affairs; facilities and space management; fundraising; and compliance with applicable laws and regulations.
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With partnerships from other parts of Medical Affairs, Publications and Scientific Communications, Pharmacovigilance, Clinical Development, Market Access, and Commercial functions.
$190,000 - $280,000 a yearFull-timeExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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Understanding of the clinical laboratory, assay/instrument principles involving in vitro diagnostic product design and usage, and the scientific, statistical, regulatory and compliance requirements of clinical research.
$109,300 - $218,700 a yearFull-timeExpandApply NowActive JobUpdated 12 days ago
clinical research scientific affairs jobs Company: Biophase
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