Senior Director Regulatory Affairs - Clinical

Position Summary

The Senior Director, Regulatory Affairs – Clinical Development will lead global clinical regulatory strategy for assigned programs in Ocugen's retinal gene therapy portfolio, including modifier gene therapies for inherited and degenerative retinal diseases. The role will work closely with Clinical Development, Clinical Operations, Biometrics, and Safety to determine what clinical evidence is needed to support registration and how to generate it.

This position requires substantial experience applying regulatory judgment to clinical development. The successful candidate will have personally shaped pivotal study designs, led substantive FDA discussions on clinical development, and translated agency feedback into decisions about the studies or analyses needed to support a marketing application.

Responsibilities

• Own the clinical regulatory strategy for assigned programs from clinical development through registration. Define the proposed path to registration, identify evidence gaps, and recommend how and when to address them.
• Partner with Clinical Development and Biometrics on decisions about study design, patient populations, endpoints, comparators, follow-up duration, and analysis plans. Evaluate whether the proposed studies and analyses can support the intended indication and labeling claims.
• Lead the clinical regulatory strategy for interactions with FDA, EMA, and other health authorities. Define the questions and proposed positions, guide preparation of briefing packages, and lead regulatory discussions on clinical topics at key milestones, including end-of-phase and pre-submission meetings.
• Interpret health authority feedback and work with program teams to translate it into changes to development plans, protocols, analyses, or submission plans. Document commitments and ensure they are reflected in program timelines.
• Direct the clinical content of INDs, clinical trial applications, and marketing applications. Lead the clinical regulatory review of protocols, clinical study reports, the clinical overview and summaries, and responses to agency questions. Ensure the efficacy and safety evidence supports a coherent benefit-risk assessment.
• Identify and escalate clinical regulatory risks early. Present senior leadership with clear recommendations and explain the implications for trial design, timelines, and the path to registration.
• Evaluate expedited programs, regulatory designations, and pediatric development requirements as appropriate. Coordinate with CMC, Nonclinical, Quality, Medical Writing, and Regulatory Operations so the clinical strategy is reflected in the overall development and submission plan.

Qualifications

• Bachelor's degree in life sciences or a related discipline.
• At least 12 years of progressive Regulatory Affairs experience in biotechnology or pharmaceuticals, including substantial responsibility for clinical regulatory strategy.
• Demonstrated ownership of clinical regulatory strategy for at least one pivotal or registration-directed program. Experience must include shaping study design, endpoint selection, or the evidence plan for registration and explaining the rationale for those decisions.
• Firsthand experience leading substantive FDA discussions on clinical development and translating agency feedback into decisions about a development plan, protocol, analysis, or filing strategy.
• Hands-on leadership of clinical content for a BLA, NDA, or MAA, with experience assessing whether the efficacy and safety evidence supports the proposed indication.
• Ability to critically evaluate protocols, statistical analysis plans, clinical study reports, and efficacy and safety data, and explain their implications for regulatory strategy to scientific and executive audiences.

Working Conditions

This position operates in an office setting, in person, 5-days per week. Job may additionally require incumbent to be available outside of these hours to handle priority business needs.