Jobs at Ocugen, Inc.

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 accounting and financial operations, ensuring accurate SEC reporting, internal controls, audits, and timely financial statements. Partner with CFO and executive team on governance, compliance, budgeting, forecasting, and staff development. Build and scale the accounting organization to support commercialization and regulatory reporting requirements.

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.

Lead MS&T technical strategy and execution for commercial biologics manufacturing. Oversee technology transfer, PPQ/process validation, and Continued Process Verification. Implement control strategies across internal and external sites, drive data-driven process improvements, lead investigations/CAPAs, support regulatory submissions and inspections, and build a high-performing MS&T team aligned with corporate and CMC objectives.

The Executive Assistant provides administrative support to the CMO and CEO, manages calendars, travel, meetings, and confidential information while ensuring smooth office operations.

Lead identification, evaluation, execution, and management of licensing, partnership, and corporate development opportunities. Perform market and competitive assessments, build financial models and valuation analyses, coordinate cross-functional due diligence and deal execution, support negotiations, and transition executed agreements into active partnerships. Maintain BD pipeline reporting, develop processes, and coordinate governance and alliance management across Clinical, Regulatory, CMC, Commercial, Finance, Legal, and Executive stakeholders in an onsite biotech environment.