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4DMT

Executive Medical Director, (Retina Program)

RemoteUnited States only
Published
Experience
Senior
Employment
Full-time
Company size
Mid-size
$350k–$398k/yr
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Open to US only. Set where you work from to check your eligibility.

No BS summary

Senior medical leader for retina clinical development (Phase 1+), MD with ophthalmology/residency (retina fellowship preferred). 10+ years in biopharma clinical ophthalmology research, experience as medical monitor for Phase 1 retina and with gene therapy. US-remote role; up to 20% travel.

Core skills

Medical monitoringRetina clinical development

Required skills

Medical Degree (M.D.)Residency training in OphthalmologyRetina fellowship trainingICH-GCPFDA regulatory guidelinesClinical trial designClinical data analysisMedical writing

Optional skills

Board certificationExperience with gene therapy clinical studiesExperience with NDA/BLA/MAA submission planning and executionKnowledge of international regulatory guidelinesPublic speaking

What you'll do

  • 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
  • Lead 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
  • Organize and lead scientific advisory board meetings and interact with external experts and stakeholders
  • Collaborate with research organization and portfolio management to identify and support new project opportunities
  • Identify program risks and create/implement mitigation strategies
  • Other duties as assigned

What they require

  • 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
  • Willingness to travel up to 20%

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.

BiotechMid-size

Details

Apply routeGreenhouse
$350k–$398k/yr