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As Medical Director at Genmab, you will be accountable for the medical oversight of one or more clinical trials, medical review and communication of data, and medical input into regulatory documents, and presentations.
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For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates.
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Demonstrated exceptional MS Office skills – Word, Outlook, PowerPoint, Excel, Smartsheet, SharePoint and TeamsPrevious experience with full business oversight and management is desirable (i.e.,RFPs, contracting, budgeting, system development, project management) of various Medical Affairs programs (e.g., early access programs, advisory boards, publications, educational and research grants/programs, sponsorships.
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The Associate Director, Medical Writing may be tasked with the development of the following documents, including, but not limited to: clinical trial outlines, clinical trial protocols/amendments, investigators brochures, PIPs, DSURs, CSRs, Health Authority briefing books, clinical submission documents, and other clinical documentation to support the conduct of the clinical trials and regulatory submissions/filings.
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Our clinical research program provides patients with access to cutting-edge technology through numerous clinical trials. The role of Medical Director involves developing a multi-site office-based vein practice for treatment of superficial and deep venous disease, vascular surgical trainee education, contributing to the research mission of the Emory Vascular Surgery Division, staff training and development, ensuring compliance with regulatory requirements, and cultivating positive relationships with referring physicians in the community.
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Works with the VP GNAT ED, and early clinical development functions including Non-Clinical Research, Bioanalytics, Clinical Operations, Medical Writing, Program Management, CMC and Regulatory Affairs.
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Minimum of 5 years of medical affairs or clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of aforementioned) with a minimum of 3 years' experience in oncology or urology related fields.
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Clinical research scientists) and other CMT colleagues through active participation in the performance management and talent planning processes. Directing study design, protocol development, and execution of clinical research for pivotal cancer studies.
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Reporting to the SVP, Digital Health and Informatics, Sr. Medical Director, instED and Virtual Care, will collaborate closely with multiple stakeholders to drive the strategy, implementation, and ongoing management and support of CCA's virtual care and clinical technology solutions enabling CCA to improve the health and well-being of people with significant needs by innovating, coordinating, and providing the highest quality, individualized care.
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Act as medical expert and have the ability to lead interactions with external stakeholders (e.g. regulatory authorities, key opinion leaders, advisory boards, patient advocacy groups) internal stakeholders (e.g. Research, Translation Medicine, Safety, Regulatory, Global Medical Affairs and Commercial) and internal decision boards.
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The Medical Director will be responsible for clinical research activities pertaining to advancing the development of GSK’s clinical portfolio and will also have responsibility for engaging in medical dialogues with relevant scientific and medical leaders in order to lead clinical data generation activities.
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Prior experience as a responsible Medical Officer for clinical trial(s) Contributing to the overall medical strategy of the assigned clinical development programs and product pipeline as well as giving in-depth medical advice on potential new projects (internal and external.
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Genmab continues to grow and is currently seeking a Medical Director to join our Medical Solid Tumor Team, focusing on early development/First-in-human trials. Plan and execute publication and clinical communication strategy in coordination with Scientific Communications.
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Generating/reviewing clinical components of key documents (regulatory documents, registration dossiers, value dossiers, pharmacoeconomic dossiers) supporting registration, market access and commercialization of the compound(s.
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Directly or indirectly support team interactions with US health payers to answer any questions about medical or clinical research topics and supporting future inclusion of supported program in their policies.
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director technology clinical research jobs Title: medical director
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