VP/SVP Head of Clinical Development
About The Position
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. The successful candidate will partner cross-functionally with Clinical Operations, Regulatory Affairs, Medical Affairs, Quality, R&D and executive leadership to advance corporate development priorities and clinical milestones.
Requirements
- MD or DO required
- Board Certification in Ophthalmology strongly 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
Nice To Haves
- Additional advanced scientific degree preferred
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
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What This Job Offers
Job Type
Full-time
Career Level
Executive
Education Level
Ph.D. or professional degree
