Vice President, Clinical Development
Core
Strategic and operational leadership for the global development of ophthalmic genetic medicines, specifically intravitreally delivered therapies for retinal diseases like wet AMD and diabetic macular edema.
Role type
Senior IC Vice President, Clinical Development (Ophthalmology)
Builds
Global clinical development programs for late-stage biotechnology products
Domain
Biotechnology / Ophthalmology / Gene Therapy
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
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, NDA/BLA/MAA submission 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 teams responsible for development plans, study protocols, and regulatory submissions; Collaborate with Clinical Operations on trial conduct and timelines; Represent the company with external stakeholders including investors and patient advocacy groups
Seniority
Executive, strategic leadership & mentorship