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GENERAL SUMMARYThe Executive Medical Director will report to the CMO, with a dotted-line relationship to the SVP of Research & Early-Stage Product Development, and will be responsible for the design, execution, and analysis of clinical trials in the ophthalmology therapeutic area
MAJOR DUTIES & RESPONSIBILITIES:- Clinical Development Leadership
- 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
- Provides 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
- Has 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
- 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
- Other duties as assigned
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
Other Qualifications/Skills:
- Knowledge of ICH-GCP and FDA regulatory guidelines.
- Knowledge of international regulatory guidelines
- Effective written and verbal communication skills, including public speaking
Travel: up to 20%
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. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
- Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).
Base salary compensation range: $350,000 - 398,000
Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate's geographical location, relevant work experience, skills, and years of experience.
