Vice President, Clinical Development
Core
Lead global development of ophthalmic genetic medicines, serving as primary medical monitor and strategic leader for Phase 3 trials in wet age-related macular degeneration and diabetic macular edema.
Role type
Senior VP Clinical Development (Ophthalmology)
Builds
Intravitreally delivered genetic medicines for blinding retinal vascular diseases
Domain
Biotechnology / Ophthalmology / Gene Therapy
Required skills
Medical monitoring, clinical trial design, protocol development, regulatory document drafting (INDs, NDAs, BLAs, MAAs), team leadership, cross-functional collaboration, strategic planning, regulatory compliance (ICH, GCP, FDA, EMA)
Preferred skills
Retina fellowship training, drug approval experience, gene therapy experience, interactions with FDA/EMA, talent development
Technologies
None stated
Responsibilities
Serve as primary medical monitor for multiple ophthalmology clinical trials; Direct and mentor a team of medical monitors; Provide medical leadership for cross-functional workstreams including pharmacovigilance and regulatory affairs; Lead development of study protocols, amendments, and regulatory submissions; Collaborate with Clinical Operations on trial conduct and timelines; Represent the company with external stakeholders and regulatory authorities
Seniority
Executive (VP), hands-on IC with strategic leadership
