Teams at Ocugen, Inc.

Leads pharmacovigilance and medical safety for Ocugen’s clinical-stage ocular gene therapy portfolio. Oversees safety physician activities, adverse-event assessment, aggregate reporting, signal detection, benefit-risk evaluation, risk management, DSMB support, vendor management, compliance, inspections, and long-term gene therapy follow-up. Partners with clinical, regulatory, quality, legal, medical affairs, and executive teams while supporting regulatory submissions and public-company safety disclosures.

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.