Description

You will lead the design, execution, and analysis of clinical trials in the Ophthalmology therapeutic area, focusing on retina programs. You will provide strategic and operational clinical leadership across cross-functional study teams and serve as a key medical expert.

Requirements

• 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
• Effective written and verbal communication skills

Responsibilities

• 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