VP, Ophthalmology Clinical Development - Global Trials Lead

BioSpace; United States; On-site; USD 350,000 - 430,000; Full time

Job summary

4DMT is seeking an experienced physician to lead global ophthalmic genetic medicine development. The VP Clinical Development will oversee medical monitoring of trials, design protocols, review trial data, and draft pivotal regulatory documents (INDs, NDAs, BLAs, MAAs).

Collaboration with pharmacovigilance, biostatistics, and clinical operations is essential. The role requires 8+ years in biopharma drug development, Phase 3 ophthalmology experience, and a strong regulatory track record.

Qualifications

• MD degree with clinical training in Ophthalmology.
• Retina fellowship training a plus.
• Board Certification preferred.

Responsibilities

• Serve as the primary medical monitor for ophthalmology trials, overseeing patient safety and data integrity.
• Direct and mentor a team of medical monitors.
• Provide medical leadership for cross-functional workstreams (pharmacovigilance, biostatistics, regulatory affairs).
• Oversee development plans, study protocols, amendments, ICFs, INDs, CSRs, and regulatory submissions.
• Collaborate with Clinical Operations to ensure trial conduct and timelines.
• Maintain compliance with ICH, GCP and regulatory guidelines.
• Support advisory boards and governance meetings.
• Represent 4DMT to partners and external stakeholders.
• Travel domestically and internationally as needed (~20%).

Skills

Medical monitoring

Cross-functional leadership

Data interpretation

Regulatory oversight

Clinical trial leadership

Strategic planning

Communication skills

Team mentorship

Education

MD Degree

Ophthalmology training

Retina fellowship

Board Certification

Job description

4DMT is seeking an experienced physician to lead global ophthalmic genetic medicine development. The VP Clinical Development will oversee medical monitoring of trials, design protocols, review trial data, and draft pivotal regulatory documents (INDs, NDAs, BLAs, MAAs).

Collaboration with pharmacovigilance, biostatistics, and clinical operations is essential. The role requires 8+ years in biopharma drug development, Phase 3 ophthalmology experience, and a strong regulatory track record.