About the Project
We are looking for a part-time ophthalmology consultant to provide professional medical advice on an hourly basis, working approximately around 10 hours per week. Only professional expert tasks will be arranged; no trivial or administrative work.
Product Type
Bispecific antibody drug (for intraocular/retinal injection)
Indication
Neovascular Age-Related Macular Degeneration (nAMD), with or without Geographic Atrophy (GA)
Mechanism of Action
Anti-VEGF plus anti-complement C5 humanized bispecific antibody
Clinical Stage
- China: Phase II/III study ongoing, currently in Phase II stage
- United States: Phase II/III study to be initiated, planned to enroll 230 subjects across 46 sites in the U.S. and 24 sites in Europe
Core Responsibility
The primary duty of the ophthalmology consultant is to resolve professional medical issues raised by clients and provide expert opinions when consulted.
Key Professional Scope
- Provide professional medical opinions on global Phase II/III clinical trials of intraocular/retinal injected bispecific antibody for neovascular age‑related macular degeneration (nAMD, with or without GA).
- Offer scientific and medical input on the anti-VEGF + anti-complement C5 bispecific antibody program, aligned with ophthalmic clinical practice.
- Provide professional advice on medical monitoring, safety assessments, and ocular/systemic adverse events related to the study drug.
- Collaborate with internal medical monitors (MMs) on medical oversight and study-related medical queries.
- Join project meetings as needed to provide professional medical consultation for studies in China, the U.S., and Europe.
Qualifications
- At least 2 years of ophthalmology clinical experience (retina subspecialty preferred).
- Ophthalmology clinical study experience and knowledge of Retinal diseases (nAMD/GA) and anti-VEGF/complement inhibitors is highly preferred.
- Familiar with ICH-GCP and US FDA regulatory requirements.