Karen M. Oberhofer
Medical Device & Diagnostics / Program Management / Product Development / Clinical Trials
- Role
- Director, Clinical Affairs at Leica Biosystems
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Karen M. Oberhofer
20+ years in vitro diagnostic (IVD) product and program management experience with emphasis on design, development, validation, launch and support of clinical laboratory assays, systems and consumables. Demonstrated successes in leadership of clinical trials, external partnerships, product line extensions, technical product demonstrations, team leadership and market needs assessments. Specialties: Program Management, Project Planning, Good Clinical Practices, Assay Development, Intended Use Testing, Product and Process Development Phase Gate Methodology, Design Control, Communications, Personnel Development, Vendor and Customer Relationship Management
Experience
Director, Clinical Affairs
Feb 2023 — Present
Education
University of Rochester
BS
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