Description
Sr. Clinical Researcher Director and Development Scientist with 25 years experiences proposing, developing and executing projects. Expertise in Immunology and Molecular products and technology. Facilitated the transfer of knowledge from thought leaders to other scientist, advocacy groups, sales, support and marketing teams. Serve as a scientific and clinical support resource for several companies. This included direct scientific and medical support during interactions with scientist, administrators or payers. Provide peer-level leadership, mentoring and training functions for research and development, support and sales teams. Developed process and perform technology transfer and product launch for FDA and IVD approved products. Write documentation for performance vs. design test . Test systems instruments reagents and software. Managed Clinical Research for filing 510K, IND and pre-marketing approvals, Perform market development activities for new products and indications. Provide assistance on special projects in conjunction with Project Management, R&D, Marketing, Sales, Clinical Development, Research & Development and Quality Assurance.