Meet The Team
Maria Vassileva, PhD
Director, Clinical Research Science
As the KAI Director of Clinical Research, Maria Vassileva leads the internal scientific team at the company while overseeing external medical consultants and serving as a liaison to outside medical and research experts from academia, government, and the private sector. She develops, designs and implements clinical trial protocols, informed consent forms and CRFs for Phase I-IV clinical trials, and interfaces with Principal Investigators and key opinion leaders. She also confers with our biostatisticians to assess and makes recommendations to clients on statistical issues, including statistical analysis plan, randomization scheme, safety monitoring and reporting characteristics for client sponsored clinical trials. She provides leadership and participates in writing and editing clinical study reports, draft presentations and manuscripts, and other research, scientific, and technical documents. She advises on best practices for DMCs/DSMBs, and provides review, analysis, and categorization of clinical studies, and grants for clients. Maria guides and leads clinical research management teams, coordinates research staff, and ensures appropriate integration of cross-functional team members to achieve scientific objectives, project deliverables and budget goals are met.
As an integral member of the KAI Senior Management Team, Dr. Vassileva takes an active role in planning, directing, reviewing and implementing all aspects of organization’s strategic objectives, clinical research implementation, business development, and policies/SOP development and implementation. She identifies and qualifies opportunities for KAI within government and commercial business sectors, present to senior management team for review, and participates in business development go/no go decisions. She also leads proposal development and participates in bid defenses, and contributes to the company long range planning and strategic planning processes.
Dr. Vassileva holds a Doctorate of Philosophy in Biochemistry and Cellular biology from the Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland, with a Vaccine Science and Policy Certificate. She holds a Bachelor of Science in Biology and Chemistry with a minor in Mathematics from Concord University in Athens, West Virginia. Prior to KAI Research, she was the Director for Strategic Program Development at Social & Scientific Systems, and before that a Senior Scientific Program Manager at the Foundation for the NIH (FNIH). At FNIH she oversaw a portfolio of complex clinical public private partnerships with budgets over $60M, including the Accelerated Medicines Partnership in Type 2 Diabetes, and all programs under the Biomarkers Consortium Metabolic Disorders Steering Committee umbrella, with focus on Type 2 Diabetes, cardiovascular disorders, musculoskeletal disorders, bone quality and obesity.
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