Karen Raudibaugh

Karen is the Vice President of Clinical Development Operations at Gate Neurosciences. She is an accomplished biopharma executive with more than 35 years’ experience planning, developing and leading global clinical teams and clinical programs from IND to NDA/BLA within large, mid-size, start-up pharma and biotech. Karen joined Gate most recently from ACADIA Pharmaceuticals Inc. where she was VP of Clinical Operations and grew the clinical operations function over 7 years, developing a best-in class team of clinical professionals. At ACADIA, Karen co-led the clinical delivery team for the recent DAYBUE™ (trofinetide) oral solution approval in adults and children with Rett syndrome and served as a strategic and operations leader in the clinical development of NUPLAZID™ (pimavanserin) across major depressive disorder, schizophrenia, and psychosis in Alzheimer’s, dementia, and Parkinson’s disease.

Prior to joining ACADIA, she headed clinical operations at AstraZeneca’s Neurosciences Innovative Medicines (iMED) unit, advancing programs in Tourette’s disorder, diabetic neuropathy, generalized anxiety disorder and multiple system atrophy. Karen also served as a clinical operations leader at Auxilium Pharmaceuticals, where she led the clinical operational delivery for XIAFLEX® (collagenase clostridium histolyticum) in both Dupuytren’s contracture and Peyronie’s Disease indications and early phase trials for QWO in cellulite. Also, while at Nycomed and Nycomed Amersham Imaging, Karen contributed to the approvals of Omniscan® (gadodiamide), Teslascan® (mangafodipir) and MyoView™ (kit for the preparation of technetium Tc99m).

Over her more than 35-year career, she has been an inspiring coach and mentor and has helped to develop investigators and site personnel as well as the next generation of global pharmaceutical leaders. Karen is passionate about developing and adhering to robust process for good clinical practice and delivering excellence in clinical data. She has been a key contributor to successful FDA inspections and is an enthusiastic speaker on inspection and submission readiness.

Karen holds a B.S. in Biology and German from Muhlenberg College in Allentown, PA and speaks Dutch and German.

Back to Leadership