Director of Clinical Trial Management

• Sep 2023 - Present

Company Owner

• Apr 2023 - Present

Vice President Clinical Operations and Medical Affairs

• Oct 2021 - Apr 2023

Strategic project consulting for a wide array of preclinical and clinical therapeutic areas for medical device and diagnostics research. Full clinical operations support, including medical writing, protocol design, site selection/qualification/startup, contracting, CEC/DSMB creation and oversight, data management, vendor management and data analysis/report writing. Strategic project consulting for a wide array of preclinical and clinical therapeutic areas for medical device and diagnostics research. Full clinical operations support, including medical writing, protocol design, site selection/qualification/startup, contracting, CEC/DSMB creation and oversight, data management, vendor management and data analysis/report writing.

Vice President Clinical Affairs

• 2015 - 2021

Designed and conducted clinical strategy for an IDE randomized clinical trial in a trauma indication for a drug/device combination product via DeNovo and PMA pathways. Designed and conducted clinical strategy for an IDE randomized clinical trial in a trauma indication for a drug/device combination product via DeNovo and PMA pathways.

Clinical Director / Sr. Clinical Director

• 2008 - 2014

Lutonix was acquired by CR Bard in 2012. Built clinical department and ran multiple worldwide clinical trials for a peripheral vascular indication with a drug coated angioplasty balloon. The DCB was approved at FDA Panel via a unanimous decision. Lutonix was acquired by CR Bard in 2012. Built clinical department and ran multiple worldwide clinical trials for a peripheral vascular indication with a drug coated angioplasty balloon. The DCB was approved at FDA Panel via a unanimous decision.

Director of Preclinical Research

• 2007 - 2009

Designed and executed a novel GLP compliant preclinical program for a novel drug/device combination product (DCB) that accelerated the development timeline and led to an expedited IDE approval. Designed and executed a novel GLP compliant preclinical program for a novel drug/device combination product (DCB) that accelerated the development timeline and led to an expedited IDE approval.

Preclinical Research Manager

• 2003 - 2007

Led and managed preclinical GLP studies for peripheral vascular devices across a broad array of therapeutic areas. Selected appropriate models and laboratories tailored to each project's devices and safety parameters. Led and managed preclinical GLP studies for peripheral vascular devices across a broad array of therapeutic areas. Selected appropriate models and laboratories tailored to each project's devices and safety parameters.

Clinical Research Manager

• 2001 - 2003

Project manager for large PMA study. Responsible for overseeing large clinical team and developing and executing a physician training program.

Research Scientist

• 1997 - 2001

Led translational preclinical research functions to evaluate various early stage research concepts and devices. Work included glucose monitoring, ischemia monitoring and early detection of effusion in heart failure.