VP/SVP Head of Clinical Development
Position Summary
The VP/SVP, Head of Clinical Development provides strategic, scientific/medical, and operational leadership across Ocugen’s clinical development programs. This individual will lead the design, execution, and oversight of clinical development strategies supporting ophthalmology and gene therapy programs from early-stage development through late-stage clinical trials and regulatory submissions, including IND and BLA-enabling activities. The role requires a collaborative and hands-on clinical development leader capable of operating effectively within a fast-paced biotechnology environment.
Responsibilities
Lead integrated clinical development strategies aligned with corporate, scientific, and regulatory objectives
Develop and execute clinical development plans supporting programs from early-stage development through Phase 3 trials and regulatory submissions
Drive clinical positioning, protocol strategy, endpoint selection, patient population strategy, and overall development planning
Translate scientific, medical, and clinical insights into actionable development plans and execution strategies
Provide scientific and medical leadership for the design and execution of clinical studies, including protocol development and study strategy
Oversee clinical trial conduct to ensure execution according to protocol, timelines, budget, quality standards, and regulatory requirements
Monitor program progress, clinical data trends, safety findings, and emerging risks to support timely decision-making
Partner closely with Clinical Operations and Biometrics to ensure effective study execution and data quality
Oversee analysis and interpretation of clinical trial data to inform development strategy and regulatory decision-making
Lead preparation of clinical summaries, presentations, publications, and scientific communications
Present clinical development updates and data to executive leadership, Board members, investigators, partners, and external stakeholders
Build and maintain strong relationships with key opinion leaders, investigators, scientific advisors, CROs, and clinical research sites
Lead clinical advisory boards and scientific discussions supporting development strategy
Represent Ocugen at scientific meetings, conferences, and industry engagements
Partner closely with Research, Regulatory Affairs, Clinical Operations, Biometrics, Medical Affairs, Quality, Manufacturing, and Program Management teams to ensure integrated program execution
Support strategic planning, portfolio prioritization, and evaluation of external collaborations or licensing opportunities
Provide medical and clinical development input supporting translational and preclinical research activities
Lead, mentor, and develop members of the clinical development organization
Foster a collaborative, accountable, science-driven, and execution-focused environment
Support recruitment, development, and retention of high-performing clinical personnel
Qualifications
MD or DO required; Board Certification in Ophthalmology strongly preferred
Additional advanced scientific degree preferred
Minimum 7-10 years of biotechnology and/or pharmaceutical industry experience in clinical development leadership roles
Significant ophthalmology clinical development experience required, including retinal disease and advanced ophthalmic therapeutics
Experience with gene therapy, biologics, rare disease, or advanced therapeutic development strongly preferred
Demonstrated experience leading programs across multiple phases of clinical development, including late-stage and BLA-enabling studies
Deep knowledge of ophthalmology clinical trial design, FDA regulatory expectations, ICH-GCP guidelines, clinical endpoints, and safety oversight
Prior experience supporting FDA interactions and preparing clinical components of regulatory submissions
Strong understanding of clinical data analysis, interpretation, and benefit-risk assessment
Proven ability to operate effectively within a small to mid-sized biotechnology company requiring both strategic leadership and hands-on execution
Strong communication, executive presence, and cross-functional leadership capabilities
Demonstrated success leading within matrixed and highly collaborative environments