Description

You will lead the design, execution, and analysis of clinical trials in the Ophthalmology therapeutic area, focusing on retina programs. As a key medical expert, you will provide strategic and operational clinical leadership across cross-functional study teams, oversee patient safety and data integrity, and engage with external experts and regulatory bodies.

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.
• Knowledge of international regulatory guidelines a plus.
• Effective written and verbal communication skills, including public speaking.

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.