Teams at Ocugen, Inc.

Provides medical and operational leadership for pharmacovigilance and patient safety across ocular gene therapy programs. Responsibilities include adverse-event assessment, signal detection, benefit-risk evaluation, aggregate reporting, safety surveillance, regulatory submissions, vendor oversight, inspection readiness, audits, CAPAs, safety training, and cross-functional safety strategy. The role personally reviews critical safety cases and supports DSMB/IDMC activities while maintaining compliant, inspection-ready PV processes.

Supports Phase 1–3 clinical trials from site start-up through closeout. Coordinates investigational sites, CROs, vendors, and internal teams; monitors site performance, enrollment, data quality, safety follow-up, documentation, investigational product tracking, and regulatory readiness. Maintains CTMS, eTMF, study trackers, and metrics while supporting audits, inspections, budgets, invoices, and process improvements. Requires at least three years of clinical research experience and up to 20% travel.

Supports clinical trial start-up, execution, maintenance, and closeout activities. Responsibilities include managing CTMS and eTMF documentation, tracking investigational products, enrollment, samples, queries, budgets, and invoices, coordinating site activation and regulatory submissions, conducting TMF quality control, supporting CRAs and vendors, and maintaining inspection readiness and compliance with protocols, SOPs, ICH-GCP, and applicable regulations.