Vice President, Head
Effective, creative joint replacement technology for surgeons
Accomplished clinical research professional with experience in the oversight of a highly skilled Clinical Operations department. Skilled in navigating and managing within a corporate partnership with another R&D organization. Expertise in cross-functional activities including: data management, biostatistics, pharmacovigilance, and medical writing. Core competencies include: Clinical Operations departmental management ♦ Synthetic biology, gene therapy, and immunotherapy ♦ Experience in Phase I, II, and III clinical trials including, but not limited to, the therapeutic areas of Oncology, Central Nervous System, and Autoimmune Diseases ♦ Management of several projects simultaneously in a fast-paced environment ♦ Line management experience ♦ Clinical program development ♦ Clinical site management ♦ Timeline and budget management ♦ Risk mitigation ♦ Coordination of multidisciplinary teams ♦ Implementation of study related activities in compliance with regulatory requirements and GCPs ♦ Electronic data capture systems
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