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.
• Residency training in Ophthalmology with a preference for subspecialty training in retina.
• Board certification/retina fellowship training are a plus.
• 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.

Knowledge

• Knowledge of ICH-GCP and FDA regulatory guidelines.
• Knowledge of international regulatory guidelines.

Skills

• Effective written and verbal communication skills, including public speaking.

Physical Requirements And Working Conditions

• Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers.
• Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling.
• Talking: Expressing or exchanging ideas by means of the spoken word.
• Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body.
• Sedentary work involves sitting most of the time.
• Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).

Pay

• Base salary compensation range: $350,000 - 398,000

Schedule

• Not specified