Director Clinical Research Regulatory Affairs at St. Jude Children's Research Hospital
📍 Shelby County, Tennessee, United States
Patti Lehigh is the Director of Clinical Research Regulatory Affairs at St. Jude Childrens Research Hospital. An expert with a Ph. D. from Louisiana State University and RAC certification, she has deep experience in regulatory submissions for drugs and medical devices. Colleagues describe her as knowledgeable, efficient, and accurate.
Based in Memphis, Patti demonstrates a strong passion for social justice and allyship. She actively follows developments in the broader pharmaceutical industry, taking an interest in major companies like GSK and Abbott, reflecting her commitment to staying current on industry trends.
She has a unique background spanning corporate medical device development at Bayer and pediatric clinical research at St. Jude.
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Experience
30 Years
Current Role
Director Clinical Research Regulatory Affairs
Job Level
Mid-senior
Location
Shelby County, Tennessee, United States
Personality Overview
How Patti shows up
Confident & Optimistic
Decisive
Generous
They usually prefer to drive the conversation. They measure a product on its merit but can be influenced by strong testimonials. They respond well to objective pitches but also attach some value to relationships.
Priorities
Topics Patti cares about
Regulatory Strategy
As a certified director, she has an extensive background in managing agency submissions for investigational products, new drugs, and medical devices.
Pediatric Clinical Research
Her current role is centered on managing the complex regulatory affairs for clinical research specifically involving children at a leading research hospital.
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Career
Work history
5-2019
Director Clinical Research Regulatory Affairs
St. Jude Children's Research Hospital
8-2018 - 2-2019
Quality and Regulatory Specialist
MAETRICS
8-2018 - 2-2019
Senior Associate Quality, Clinical Research and Regulatory Affairs Specialist
MAETRICS
3-2015 - 5-2018
Senior Associate Director CAPA Risk Manager
Bayer HealthCare
9-2012 - 2-2015
Associate Principal Scientist - Medical Devices
Bayer HealthCare
In the press
Media appearances
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Influence (I) reflects the degree to which a person prefers to work by influencing or persuading others. Those scoring high tend to be people oriented, motivated by social recognition and building relationships.
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