Senior Medical Director, Clinical Development, Ophthalmology
Core
Lead clinical development programs for ophthalmology therapeutics, designing studies from first-in-human through registration and ensuring regulatory compliance.
Role type
Senior Medical Director, Clinical Development
Builds
Phase 1, 2, and 3 clinical programs for ophthalmology drug candidates
Domain
Biopharmaceuticals / Ophthalmology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Ophthalmology board certification, clinical trial design and execution, regulatory submission preparation, medical monitoring, safety signal detection, protocol development, stakeholder management
Preferred skills
Experience in proof of concept and registrational trials, knowledge of ICH guidelines, consensus building
Technologies
Clinical trial management systems, regulatory submission platforms
Responsibilities
Design and execute first-in-human through registration-enabling studies; act as medical expert with regulatory authorities and key opinion leaders; ensure safety of patients in clinical studies; develop regulatory submission documents; collaborate with research teams on next-generation targets
Seniority
Senior, hands-on IC