Executive Medical Director, Retina Program

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🔥 1 minute ago

🇺🇸 United States – Remote

💵 $350k - $398k / year

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

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4D Molecular Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

4DMT is a clinical stage biopharma company inventing and developing innovative products to unlock the full potential of genetic medicine to treat large market and rare diseases. Our vector discovery platform Therapeutic Vector Evolution harnesses the power of directed evolution, a Nobel Prize-winning technology, with approximately one billion synthetic AAV capsid-derived sequences to invent customized and evolved vectors with improved therapeutic profiles compared to wild-type vectors. Our product design, development and manufacturing engine empowers us to efficiently create our valuable and diverse product pipeline. This combination of bold innovation and relentless execution gives 4DMT the capability to revolutionize genetic medicines and to strive for potential curative therapies. We have built a deep portfolio of genetic medicine product candidates, with five product candidates in clinical trials for seven patient populations.

📋 Description

• Report to the CMO, with a dotted-line relationship to the SVP of Research & Early-Stage Product Development • 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 • 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 • 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 • 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

🎯 Requirements

• 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 • 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 of ICH-GCP and FDA regulatory guidelines. • Knowledge of international regulatory guidelines • Effective written and verbal communication skills, including public speaking.

🏖️ Benefits

• Equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.