Christine Ludovico

Executive Director Clinical Operations @Aeon Biopharma, Inc

Irvine, CA, US
MOBILE NUMBERS
+17•••••••16

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WORK HISTORY

Aug 2019 — Present

Executive Director Clinical Operations @Aeon Biopharma, Inc

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Irvine, CA, US

Responsible for overall clinical operations of ABP-450 botulinum toxin clinical program including Cervical Dystonia (Ph II DBL, OLE), Migraine Ph DBL, OLE), Gastroparesis, Depression. Responsible for the development and coordination of clinical documents, relevant clinical sections for key regulatory submissions and briefing books including EOP2 and BIA meetings with the FDA, preparing & managing budgets, vendor RFP process and CRO oversight, review of data and KRI, interface & collaboration with KOLs and investigators. In partnership with multifunctional groups, developed SOPs and structural infrastructure. Established and maintained company culture to foster diversity & tolerance for different-abled employees.

EDUCATION

N/A

University of California, Davis

BS

N/A

University of California, Davis

Coursework in Doctoral Program of Nutrition, emphasis on Reproductive Nutrition

SKILLS

CommunicationCross-Functional Team LeadershipElectronic Data Capture (Edc)EdcCtmsRegulatory AffairsU.s. Food and Drug Administration (Fda)Medical DevicesClinical ResearchCRO ManagementDermatologyCns DisordersPharmaceutical IndustryFdaStrategyNeurologyTeam LeadershipClinical TrialsThird Party Vendor ManagementProblem SolvingCollaborative Problem SolvingOncologyCRODecision-MakingIchClinical MonitoringClinical Trial Management System (Ctms)Drug DevelopmentGcpStandard Operating Procedure (Sop)Budget ManagementGood Clinical Practice (Gcp)Cross-Functional CollaborationsPharmaceuticsPresentation SkillsDecision AnalysisIch-GcpOrganizational LeadershipClinical Study DesignLeadership Development

ABOUT CHRISTINE LUDOVICO

Clinical Research & Medical Affairs Professional with 25+ years experience recognized for…

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