Staff scientist with 15 years of industry/academic experience on medical device, systems integration, assay development, clinical study management. Currently focused on the management of several clinical studies for the Translational Vascular Medicine Branch at NHLBI to study rare genetic diseases that have vascular phenotype. Previously, heavily involved in design of IVD coagulation assays, reagent formulation, stability testing, formulation of quality control materials and manufacturing scale-up development. Experience developing clinical protocols, managing and supporting clinical trials, setting up clinical collaborations and training clinical staff. Documentation and writing experience for grants, papers, SOPs, manufacturing instructions, clinical training materials, IRB approval, and clinical protocols. Successfully worked with clinicians, regulatory, quality and medical teams.
Listed skills include Cell Culture, Elisa, Molecular Biology, Biomedical Engineering, and 45 others.