Bio
Experience
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Director Medical Information
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May 2024 - Present
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Associate Director US & Global Medical Content
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Dec 2023 - May 2024
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United States
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Biotechnology Research
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700 & Above Employee
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Associate Director, Global Medical Content
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Apr 2021 - Dec 2023
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Sr. Manager, Global Medical Content
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Apr 2020 - Apr 2021
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Sr. Field Medical Excellence Manager
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Sep 2017 - Apr 2020
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Field Medical Excellence Manager
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Oct 2015 - Sep 2017
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Med Information & Med Communications Manager
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Feb 2015 - Oct 2015
• Oversaw the development & reporting for MSL and CE team metrics.• Supported clinical and medical review committee process.• Developed congress abstracts, presentations and manuscripts for Pharmacyclics-sponsored clinical trials.• Reviewed and evaluated investigator-initiated clinical trials.• Adjudicated reviewer comments with internal and external authors.• Proactively reviewed and interpreted pertinent and emerging scientific literature.• Ensured medical communication conveys accurate and non-misleading messages or impressions of the product.• Supervised the work of vendors for medical writing, ensuring work is high quality and developed on time and budget.
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Pharma Clients, LLC
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Greater Seattle Area/San Francisco Bay Area
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Medical Science Consultant
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Jan 2014 - Dec 2014
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Greater Seattle Area/San Francisco Bay Area
• Identified and implemented new business opportunity in Clinical Operations in Pharmaceuticals and Life Sciences practice.• Served as a clinical science expert for medical information and medical communication.• Developed and managed medical content and product profile. • Performed strategic market, customer and competitive analysis.• Identified new professional relationships within Washington Biotechnology and Biomedical Association, Organization of Regulatory and Clinical Associates.• Partnered with key health care professionals including healthcare practitioners, start-up biotech lead management and academic institutions.• Defined and coordinated marketing campaigns.
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Postdoctoral Scientist
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Jan 2013 - Aug 2013
• Led investigation of candidate biomarkers in a clinical trial in subjects with type 1 diabetes. • Developed biomarker assay validation plan and successfully generated SOPs.• Directly supported study team in preparation and submission of regulatory documentation. Effectively monitored, oversaw communications with the FDA and local regulatory agencies/commitees.• Provided logistical support for clinical studies to CRO on the sponsor side, and supervised in CRFs development.• Directed and coordinated laboratory technicians.• Organized and presented at project team meetings with internal and external clinical laboratories and partners.
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Medical Affairs Specialist
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Jul 2012 - Dec 2012
• Architected a Medical Information Database configuration, structure and content strategy. • Compiled key medical information of company´s product portfolio for Europe, Middle East and Africa (EMEA) and assimilated its competitive intelligence data.• Collaborated with external consulting and integrating partner throughout CRM development.• Developed and supported scientific relationships with key opinion leaders and academic institutions.• Managed medical inquiries from healthcare professionals, consumers, sales representatives on marketed and investigational products.• Provided clinical expertise in construction and design of marketing promotional materials/events.• Conducted regulatory reviews of educational, technical and promotional materials in accordance with the European Medicines Agency (EMA) requirements.• Provided medical and scientific training support to Salesforce and product marketing teams.
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Charité
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Berlin und Umgebung, Deutschland
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Doctoral Researcher
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Oct 2008 - Jun 2012
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Berlin und Umgebung, Deutschland
• Established preclinical models for analysis of virus-specific immunity and virus-associated complications in renal transplant patients.• Developed a novel therapeutic approach to control polyomavirus reactivation in the post-transplant period.• Coordinated clinical trials, translational activities, and developed GMP procedures for cell-based therapies and diagnostic tests for phase I / II / III studies.• Promoted collaborations and partnerships with health economy experts, regulatory authorities, biotech and pharma industries.• Managed project progress by direct reporting to interdisciplinary scientific mentoring committee to ensure project visibility, tracking and completion.• Organized the annual PhD symposium for doctoral researchers, master's students and post-docs worldwide.
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Education
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2014 - 2014University of Washington, Michael G. Foster School of Business
Business Administration -
2008 - 2012Freie Universität Berlin
Doctor of Philosophy (Ph.D.), Life Sciences and Transplant Immunology -
2007 - 2009Samara State Medical University
Doctor of Pharmacy (PharmD) -
2003 - 2008Belarusian State University
Master/Bachelor Degree, Chemistry/Pharmaceutical Sciences
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Industry Focus. “Pharmaceutical and Healthcare”
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