SUMMARY I am a highly motivated individual that is driven to succeed, with proven strategic decision making ability and acute attention to detail, underscored by a career highlighted with numerous promotions and high level positions in successful industry and contract research laboratory (CRO) environments in an international setting. I have had great success at aligning cross-functional research and development teams to support advanced drug development. I have a high level of experience in general toxicology, safety pharmacology, teratology, and efficacy studies in both CRO and private industry work environments, as well as model development of highly specified research models. * Management of Multidisciplinary Research Teams * Extensive Experience Working Abroad * Multidisciplinary Knowledge of Research Applications * Development of Business & Research Strategies for Successful Product Development * Management of Multidisciplinary Research Teams * Extensive Experience Working Abroad * Multidisciplinary Knowledge of Research Applications * Development of Business & Research Strategies for Successful Product Development * Team Building, Training, & Leadership * Cross-Cultural Communication & Leadership * Technology Utilization & Optimization * Regulatory Compliance * Recognition of Quality System Requirements * Team Building, Training, & Leadership * Cross-Cultural Communication & Leadership * Technology Utilization & Optimization * Regulatory Compliance * Recognition of Quality System Requirements KEY STRENGTHS CAREER SYNOPSIS TOXICOLOGY RESEARCH LABORATORY (CRO), CHICAGO, IL SEPTEMBER 1998 TO CURRENT Senior Study Director / Senior Toxicologist / IT Systems Administrator Responsibilities: * Actively manage several multidisciplinary teams participating on efficacy and toxicology studies designed to comply with FDA Good Laboratory Guidelines (GLP). * Manage 15+ direct reports performing many different roles on complex research projects, including toxicology, drug efficacy, model development, information technology, finance, and basic research driven positions. * Preparation of study protocols, data analysis, and preparation of reports for cardiac safety pharmacology, general toxicology, pharmacokinetics, and efficacy studies. * Review and approve IACUC protocol submissions. * Coordinate the participation of medical specialists to ensure efficient project completion. * Manage the IT department, including preparation and review of validation efforts for multidisciplinary projects, including computer data collection/analysis systems, analytical methods, and required procedures. * Ensure Regulatory compliance of computer systems, including the validation of many computer systems.

Highlights:

• Analytical Chemistry
• Applications
• Attention to Detail
• Compliance
• Data Analysis
• Data Management
• Due Diligence
• Good Clinical Practices
• protocol
• pharmaceutical
• ich
• GLP