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Holly Groelle

Associate Director, Regulatory Affairs @Kyverna Therapeutics

San Francisco, CA, US
EMAILS
h•••••••@kyvernatx.com
MOBILE NUMBERS
+16•••••••42

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WORK HISTORY

Aug 2023 — Present

Associate Director, Regulatory Affairs @Kyverna Therapeutics

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Direct regulatory strategy and operations to introduce cellular therapies for autoimmune disease in the clinic. Oversee clinical development in support of BLA filing. Contribute to critical thinking around study design, labeling requirements, and manufacturing to expedite delivery of cell therapies to patients.

EDUCATION

N/A

University of Maryland

B.S., Microbiology

N/A

Northeastern University

Regulatory Affairs

1992 — 1994

Dana-Farber Cancer Institute

Harvard Postdoctoral Fellow, Infectious Disease

1992 — 1992

Marine Biological Laboratory Woods Hole, MA

NIH Postdoctoral Fellow, Neuroendocrinology

N/A

Boston University School of Medicine

Ph.D., Biochemistry

SKILLS

Project ManagementGcpCell CultureDiabetesRegulatory SubmissionsPharmaceutical IndustryBiologicsFdaOncologyClinical DevelopmentPharmaceuticalsClinical TrialsMedical DevicesClinical ResearchGood Clinical Practice (Gcp)BiochemistryInfectious DiseasesU.s. Food and Drug Administration (Fda)Regulatory AffairsPharmaceuticsClient RelationsMolecular BiologyIn Vitro Diagnostics

ABOUT HOLLY GROELLE

Passionate regulatory professional dedicated to achieving cost-effective patient access…

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