Timothy Antonellis

Director Clinical Operations @EyePoint

Watertown, MA, US

Lead clinical operations for assigned programs, ensuring compliance with GCP, ICH, and applicable regulationsRepresent Clinical Operations on cross-functional program teams for all assigned programsOversee global studies, providing direction to Clinical Trial Managers and CRO Study TeamsAssist in the development of project timelines to meet departmental and corporate goalsTrack KPIs for assigned trials, including clinical reviews and data query resolutionPerform ongoing assessment of operational efficiency and communication and adjust study processes to ensure high team performanceProvide senior management with timely updates on progress and changes in scopeCoordinate site outreach and enrollment effortsCommunicate regularly with key stakeholders, including Regulatory Affairs, Biostatistics, Data Management, Clinical Supply, Clinical Research, Legal, and FinanceProvides input as the subject matter expert for the study during regulatory inspectionsManages escalation of study related issues and communicates as appropriate with management and other R&D functionsTrains and manages CRO and other clinical vendor activities to ensure the quality meets EyePoint and regulatory requirementsMonitors the status of clinical data collection of assigned clinical studiesMonitors progress of clinical activity and produces regular and ad hoc reports and presentations as requiredReviews budgets and contracts with CROs, vendors, and investigative sites, as applicable

Emmanuel College (Boston)

BA, Psychology