Jay Hansen

WORK HISTORY

EDUCATION

ABOUT JAY HANSEN

Twenty-five+ years of clinical operations experience gained working for pharmaceutical/biotech companies and a CRO.• Direct involvement in all aspects of clinical development and strategic sourcing, from protocol development, study and site management, monitoring, project planning and performance evaluation, through oversight of enrollment and management of data accrual/analysis, medical writing and closeout for multiple therapeutic area studies at Pharmacia, Parexel, Takeda, and Hollister. These studies supported successful registration of ACTOS, CELEBREX, VANTIN, RESCRIPTOR, CAVERJECT, CORVERT, ZYVOX, and most recently LINZESS.• Designed, developed and directed new corporate outsourcing departments at Pharmacia, Takeda and Mannkind. Designed processes and SOPs, hired and trained direct reports and was responsible for performance and salary reviews.• Implemented the “Right First Time” process at Mannkind for regulatory document production and all medical writing projects throughout Medical Affairs, Clinical Operations, Medical Writing and WWRA. Using this process, my medical writing team successfully completed a 2009 NDA for MannKind’s dry inhaled insulin powder. This included 10 legacy CSRs that prior teams had failed to complete.• Managed integrated, multi-million dollar budgets and high level negotiations as a director at Parexel, Takeda and Mannkind. Performed cross-functional project specification reviews against bids, to realize cost savings of $11,530,200 in 2007 and 2008.Specialties: Program direction, strategic outsourcing, clinical operations, medical writing