Vice President, Late Stage Ophthalmology - DME

About This Role

This executive role provides strategic and operational leadership for global ophthalmic genetic medicine development, overseeing clinical studies, medical monitoring, and regulatory submissions. The position requires an experienced physician to lead the introduction of intravitreally delivered genetic medicines for irreversible blindness.

Responsibilities

• Serve as the primary medical monitor for multiple ophthalmology clinical trials, providing expert oversight of patient safety, data integrity, and protocol adherence.
• Direct and mentor a team of medical monitors, ensuring high standards of medical oversight and data review.
• Provide medical leadership for cross-functional internal workstreams including pharmacovigilance, biostatistics, clinical operations, and regulatory affairs.
• Provide oversight and lead teams responsible for development plans, study protocols, amendments, and various regulatory submission documents.
• Collaborate closely with Clinical Operations and be accountable for clinical trial conduct and timelines for associated key deliverables.
• Ensure adherence to compliance, SOPs, ICH, GCP, and relevant regulatory guidelines.
• Provide medical leadership for internal audits and regulatory inspections.
• Assist in preparation of materials for Advisory Board meetings and BOD meetings.
• Represent 4DMT and lead interactions and collaborations with potential partners.
• Represent the Ophthalmology Therapeutic Area with key external stakeholders including patients, advocacy groups, experts, investors, and business communities.

Requirements

• M.D. Degree
• Clinical training in Ophthalmology
• Minimum of 8 years of biopharma industry experience in drug development
• Prior Clinical Trial experience in Retina, Diabetic Eye Disease
• Experience in participating or leading global regulatory interactions
• Integrated understanding of FDA, EMA, ICH, and GCP guidelines

Qualifications

• M.D. Degree
• Minimum of 8 years of biopharma industry experience in drug development

Nice to Have

• Retina fellowship training
• Phase 3 experience in retinal disease(s), diabetic eye disease highly preferred
• Experience with NDA, BLA or MAA submission(s)
• Drug approval(s)
• Experience with gene therapy, other areas of Drug Development and commercialization
• Prior interactions with FDA and EMA regulatory agencies

Skills

* Required skills