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Ira Katz, MA
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Ira Katz is the Vice President of Business Development for Johnson & Johnson's Global Clinical Operations (GCO) organization. Mr. Katz began his career in the pharmaceutical industry in 1979 as a Medical Research Associate for Ayerst Laboratories. As the GCPs took hold, Mr. Katz became interested in the quality aspects of clinical trials and took a position as a GCP auditor in the Research Quality Assurance Department, soon leading a department of twelve GCP QA auditors. His experience in basic research immunology earned him the assignment of creating the GLP QA program for the bioanalytical laboratories at Ayerst's Princeton research facility. As the Director of Regulatory Compliance for Whitehall Laboratories, he became familiar with OTCs. Joining Janssen in 1988 as the Director of Research QA, Mr. Katz was responsible for creating the Clinical QA function. In 1990 he took leadership responsibility for all operational aspects of the conduct of clinical trials, including the Clinical Research Associates for all therapeutic areas, the Clinical Research Training Group, and the Clinical Supply Unit. After helping to re-engineer the global clinical trial execution process, Mr. Katz was appointed head of the Department of Clinical Trials Management. He was promoted to Executive Director, Project Management, in 1996, and in 1999 to Vice President, Global Product Leader for the Analgesia R&D franchise of Janssen Research Foundation. Immediately prior to joining GCO Mr. Katz was responsible for the clinical operations function for the early development (Phase I/IIA) organization of Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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