- Planning and timeline managed (clinical project management leadership)
- Financial Forecasting
- Identification/research and management of external service providers
- Primary Therapeutic areas experience; Oncology and Infectious Disease
- Resource allocation
- Built/expanded Clinical groups to address goals and objectives
- Leadership of projects that ultimately increased the profitability of the company
- US and European clinical audits
- Management of Proof-concept, phase 1, 2 and 3 global clinical trials including use of clinical trial software management tools such as CTMS, and EDC.
Professional Experience
March 2009 – Present
Independent Consultant, Clinical Services
As a Consultant, provided Clinical Operations guidance to emerging Biotech Companies.
ArQule Inc. Woburn, MA
May 2007 – October 2008
Vice President of Clinical Operations, Clinical Department
Arqule is a small biotech company developing Oncology drugs; the company is in phase 1, 2a and 2b development, Domestic and international clinical studies.
AVEO Pharmaceuticals
August 2006 – May 2007
Independent Consultant
AVEO is a small biotech company developing Oncology drugs; the trial was in phase 1 development.
Therion Biologics Corp. Cambridge, MA
April 2005 - June 2006
Vice President of Clinical Operations, Clinical Affairs Department
Therion Biologics is a privately owned Cancer Vaccine Company with Phase 2 Prostate Cancer and Phase 3 Pancreatic Cancer Clinical Trials. Company did not meet the primary endpoint of progression free survival in the Pancreatic Cancer clinical trial and as a result, the company no longer exists.
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Education / Professional Development
MBA, UC – Coast, Santa Anna, CA
BS, Biology Greensboro College, Greensboro, NC
Webinars: Risk Management, Regulatory Landscape-Clinical Trials, FDA guidence in Clinical Trials
