Executive Medical Director, (Retina Program)

Major Duties & Responsibilities

• Serve as the clinical lead for Phase 1 retina clinical trials, including study design, protocol development, dose escalation strategy, and safety oversight
• Maintain accountability for study execution, data interpretation, and clinical readouts, including early signal detection and go/no-go recommendations
• Serve as medical monitor for assigned studies, ensuring subject safety and data integrity
• Lead cross-functional study teams (clinical operations, clinical science, biometrics, regulatory, safety, CMC, etc.) to ensure high-quality and timely trial delivery
• Provide clinical leadership to multidisciplinary study execution teams drawn from clinical operations, clinical science, biometrics, regulatory affairs, CMC, pharm/tox, drug safety, commercial, and alliance partners
• Have lead accountability on the study teams for delivery of study protocols, study conduct, and study readouts

Biomarker & Translational Strategy

• Lead development and implementation of biomarker strategies for GA and broader retina programs
• Collaborate with research and translational teams to identify, validate, and integrate imaging, molecular, and functional biomarkers into early-phase trials
• Ensure biomarkers are aligned with mechanism of action, dose selection, and clinical endpoints to support decision-making and regulatory strategy
• Ensure accuracy, scientific rigor, and regulatory compliance of all clinical documents

Regulatory & Clinical Documentation

• Serve as the primary clinical author of development plans, protocols, IBs, INDs, CSRs, and regulatory responses
• Lead clinical contributions to IND submissions and early regulatory interactions, including Health Authority meetings for Phase 1 programs
• Ensure accuracy, scientific rigor, and regulatory compliance of all clinical documents

External Scientific Leadership

• Organizes and leads scientific advisory board meetings. Interacts with external experts and stakeholders to gather input.
• Works with the research organization and the portfolio management team to identify and support new project opportunities.
• Collaborates to identify program risks, and to create and implement mitigation strategies

Qualifications

• Education: Medical Degree (M.D.), other degrees considered with relevant experience
• Experience: 10+ years of clinical ophthalmology research in the biopharmaceutical industry
• Experience with medical monitoring and oversight of Phase 1 retina clinical trials
• Experience with gene therapy clinical studies
• Experience in other phases (Phase 2, 3) of clinical research
• Experience with NDA/BLA/MAA submission planning and execution
• Experience in data analysis, data interpretation, and medical writing