Project Experience

Examples of projects delivered.  References avaialble upon request.

Cross Functional Pharmaceutical Drug Development

NDA delivery team leader responsible for delivery of an NCE from last data collected to NDA & MAA submissions in record time for a large pharma company.

Clinical Drug Development - Phase 3 Rescues

Successfully rescued multiple phase 3 programs that were being delivered by CROs for pharma clients but not performing to expectations.  In each case, a specific plan of action was created and implemented resulting in these programs delivering to re-baselined timelines agreed with senior management teams.

Partnerships, Alliance Management and M & A

Led the implementation of a global outsourcing model for a pharma organization across the delivery of all phase 2 & 3 studies.  Served as lead for the acquisition and integration of a small biotech company by a large pharma company.  Acted as alliance manager in several critical CRO/pharma and pharma/pharma relationships.

Project Management Methodology and Project Office

Served as lead and team member in multiple project management process projects in several organizations.  These include:  project management maturity assessments, portfolio and resource management models, project office development, and implementation of project management methodologies and software.