Lead clinical strategy and execution for ophthalmology trials, including protocol development, study oversight, and data interpretation.
Serve as medical monitor for clinical studies, ensuring patient safety and data integrity.
Author and review clinical documents including protocols, IBs, ICFs, INDs, CSRs, and regulatory submissions.
Collaborate with cross-functional teams (clinical operations, regulatory, biometrics, safety, CMC, commercial) to drive program success.
Engage with external experts, organize advisory boards, and contribute to scientific and medical communications.
Identify and mitigate clinical and programmatic risks.
Support portfolio development and evaluation of new clinical opportunities.
Represent the company in regulatory and scientific forums as needed.

Medical Degree (M.D.), OD, PhD, PharmD or equivalent
Residency training in Ophthalmology with a preference for subspecialty training in retina
Board certification a plus
Retina fellowship training a plus
5+ years of clinical ophthalmology research in the biopharmaceutical industry
Experience with Phase 3 retina clinical trials
Experience with gene therapy a plus.
Experience in other phases (Phase 1, 2, 4) of clinical research a plus.
Experience with NDA/BLA/MAA submission a plus.
Experience writing clinical research protocols and acting as a medical monitor
Experience in data analysis, data interpretation, and medical writing
Knowledge of ICH-GCP and FDA regulatory guidelines.
Knowledge of international regulatory guidelines a plus.
Effective written and verbal communication skills, including public speaking.

Equal employment opportunities without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.

Medical Director

Key skills