Jobs 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.

Support clinical development by parsing and reviewing trial data, producing analyses, visualizations, and slide decks, and collaborating with Biostatistics, Data Management, and Clinical Operations to ensure data quality, perform ongoing safety/efficacy review, and contribute to study documentation and decision-making.

Independently lead planning, execution, and delivery of clinical trials from start-up through close-out. Manage timelines, enrollment, vendors/CROs, investigator engagement, eTMF/documentation, regulatory compliance, budgets, and cross-functional coordination. Anticipate and mitigate operational risks and support inspection readiness.

Lead operational management of clinical trials from initiation through close-out, overseeing cross-functional teams, vendors/CROs, timelines, budgets, regulatory compliance, clinical systems, site activities, and process improvements to ensure high-quality data and study delivery.

Lead TMF operations across clinical studies using Veeva Vault eTMF, ensuring completeness, inspection readiness, QC reviews, reconciliation, CAPA, audit support, vendor oversight, training, and SOP/process improvements throughout study lifecycle.

Lead clinical data management for trials and marketed products: design databases and eCRFs, develop/validate edit checks, ensure inspection readiness and regulatory compliance (GCP/ICH/CDISC), mentor staff, manage vendors, and coordinate cross-functional data deliverables.

Lead and build the Biostatistics function, define enterprise statistical strategy across clinical programs, ensure regulatory-ready analyses for gene therapy and rare disease, oversee study design, SAPs, TLFs and CDISC-compliant datasets, manage CROs/vendors, lead regulatory interactions, and translate statistical results for executive decision-making.

Lead cross-functional drug development programs from concept to commercialization. Drive strategy, risk mitigation, resource planning, governance, and timeline management. Coordinate with R&D, CMC, regulatory, CDMOs/CROs and commercial teams, ensure GxP quality, prepare reports, and implement program management best practices while coaching teams and reporting status to senior leadership.