Vice President, Clinical Development, Ophthalmology

Role Summary

Vice President, Clinical Development, Ophthalmology — provide strategic and operational leadership for the global development of ophthalmic genetic medicines in Drug Development, reporting to the Chief Medical Officer.

Responsibilities

• Serve as the primary medical monitor for multiple ophthalmology clinical trials, providing expert oversight of patient safety, data integrity, and protocol adherence throughout study execution.
• Direct and mentor a team of medical monitors, ensuring high standards of medical oversight and data review, while maintaining personal accountability for real-time monitoring activities and timely delivery of critical clinical trial outputs.
• Provide medical leadership for cross-functional internal workstreams including pharmacovigilance, biostatistics, clinical operations, regulatory affairs, etc.
• Provide oversight and lead teams responsible for development plans, study protocols, amendments, ICFs, IBs, INDs, annual reports, CSRs, regulatory response documents and other regulatory submissions or documents as appropriate.
• Collaborate closely with Clinical Operations and be accountable for clinical trial conduct and timelines for associated key deliverables.
• Keep up to date with compliance, SOPs and adhere to ICH, GCP, and relevant regulatory guidelines.
• Provide medical leadership for internal audits and regulatory inspections.
• Assist in preparation of materials for Advisory Board meetings, Board of Directors meetings, etc.
• Represent 4DMT and lead interactions and collaborations with potential partners.
• Represent the Ophthalmology Therapeutic Area with external stakeholders, including patients, patient advocacy groups, external experts, investors, and the ophthalmic and biotech communities.
• Other duties as assigned.

Qualifications

• M.D. Degree; Clinical training in Ophthalmology; Retina fellowship training a plus; Board Certification (or equivalent).

Experience

• Minimum of 10 years of biopharma industry experience in drug development.
• Phase 3 experience in retinal disease.
• Experience with NDA, BLA or MAA submissions; drug approvals a plus.
• Experience with gene therapy or other areas of drug development and commercialization is a plus.

Skills

• Strong interpersonal skills and high emotional quotient; excellent written and verbal communication; analytical, problem-solving, and strategic planning abilities.
• Up-to-date understanding of the ophthalmic competitive landscape with focus on retina; prior clinical trial experience in Retina.
• Experience participating in or leading global regulatory interactions; ability to translate complex data into key messages; thrive in a fast-paced environment.
• Proven ability to prioritize, plan, and conduct clinical trials with high-quality execution within timelines; effective in cross-functional teams and matrixed environments.
• Track record of strategic thinking, influencing senior leaders, and developing talent; strong integrity and collaboration across internal and external partners.
• Ability to manage ambiguity, handle conflict, and maintain accountability.
• Integrated understanding of FDA, EMA, ICH, and GCP guidelines; prior interactions with FDA/EMA desirable.

Education

• MD Degree; Clinical ophthalmology training; retina fellowship a plus; board certification.

Additional Requirements

• Travel: Domestic and international travel up to 20%.
• Physical requirements: sedentary work with potential for repetitive motions; standard office environment.