Curriculum Vitae

• Clinical Management Leader
• Project Management
• Trial Planning/Strategy
• Product Lifecycle Development and Planning
• LEAN Six Sigma Consultant
• CRO Selection and Management
• IND/IDE and PMA/NDA Submission Experiences
• Budget Management and Forecasting
• Clinical Trial Management System (CTMS) and electronic Trial Master File (eTMF)

• Device and biotech start-ups: clinical SOP development, work flow optimization, CRO management
• Software development: clinical optimization with analytics, forecasting and process improvements
• Global biopharma companies: clinical program and trial management, CRO selection, contract and budget negotiations

• Managed ~20 clinical staff; recruited 8 CRAs in 8 months (2012), promoted 8 (2012-2015). 
• Improved CRA retention from 60% to 100% (2013 to 2014).

• Oversight of cardiac bypass post marketing studies and investigator initiated studies
• Led vascular graft clinical trial for Maquet Vascular; 20+ US sites, enrollment goal >150 patients
• first patient enrolled (FPI) in less than 90 days from final protocol
• 4x workload, but achieved FPI in half the time compared with prior year

• Optimized workflow in Drug Safety on global clinical trial; reducing time for completion of SAE reports, expediting data collection and query resolution, coordinating with CRO on reporting.
• Scaled up clinical operations department by 133%; 32 (2004) to 77 (2005), turnover 7% (2005)
• Created new groups to improve efficiency, quality and leverage core capabilities;
• Clinical accounts: trial budgeting and forecasting, clinical site and vendor payments
• Vendor management; create sourcing strategies, develop and negotiate vendor agreements
• Clinical supply chain; streamlined supply management with LEAN methods
• Successfully developed clinical development strategy for in-licensed cardiovascular product life cycle development; aggressive global product development in major markets, leveraging CROs
• Managed increasing clinical operations budget; ~$30M (2004), ~$60M (2005), >$100M (2006)
• Reduced approval of legal agreements time by 56% (>90 to <30 days)

• Coordinated and coached clinical research associates (CRA) in creating 5 clinical development plans for new treatment indications on approved products (2001 to 2002):
• Radiation program: 700 patients at 70 US sites, 4-year study, ~$9M
• Drug/device combination programs: 1700 patients at >90 US sites, 3-year study, ~$20M
• Led project management group in clinical: creating >30 new clinical project timelines, representing workload for ~100 employees and 20 contractors, enabling management to make informed decisions and plans about resource requirements and project progress.
• Collaborated on creating detailed performance benchmarks for 4 CRA levels and development milestones resulting in more equitable and consistent performance assessments for ~20 CRAs.

• Facilitated merger of two former competitors’, Eclipse’s and Cardiogenesis’ clinical programs in preparation of PMA submission of 2nd generation product and FDA site audits, and closing pivotal trial of 1st generation product.
• Initiated creation of 2 new program timelines representing workloads of 12 employees in Clinical Affairs and Data Management- with an annual budget of ~$3M.  More accurate and timely information were available to assess project status and team performance.
• Began to collect baseline performance metrics: study regulatory compliance, data management processes and management capabilities of new program managers, in anticipation of creating performance targets for the department, group and individuals.

• Initiated and organized Miravant’s first Pharmacovigilance Committee: retrospectively investigated and collected serious adverse events (SAE) data from previous 4 years to prepare 20 comprehensive SAE investigations in 4 months.  Resulted in savings weeks in preparing IND and NDA reports, and provided more accurate and complete safety profile.
• Led and managed clinical team of 12: site monitoring, data collection, QA audits and PMA submission for pivotal trial at 8 US sites enrolling 292 patients in 3 years.  
• PMA submission in 2000, panel presentation in 2000 and FDA approval in 2001.