Executive Medical Director, (Retina Program)

4D Molecular Therapeutics

3d•$350,000 - $398,000

About The Position

4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery. GENERAL SUMMARY The 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

Requirements

Medical Degree (M.D.), other degrees considered with relevant experience
Residency training in Ophthalmology with a preference for subspecialty training in retina
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

Nice To Haves

Board certification/retina fellowship training are a plus

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
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