4dmoleculartherapeutics

Executive Medical Director (Retina Program)

Remote, United States. Posted 4 months ago

The role

The Executive Medical Director will design, execute, and analyze clinical trials in the ophthalmology therapeutic area. This role reports to the CMO and involves leading Phase 1 retina clinical trials and biomarker strategies.

What you will do

  • Serve as clinical lead for Phase 1 retina clinical trials
  • Maintain accountability for study execution, data interpretation, and clinical readouts
  • Serve as medical monitor for assigned studies
  • Lead cross-functional study teams
  • Lead development and implementation of biomarker strategies
  • Collaborate with research and translational teams to integrate biomarkers into trials
  • Serve as primary clinical author of development plans, protocols, IBs, INDs, and CSRs
  • Lead clinical contributions to IND submissions and regulatory interactions
  • Organize and lead scientific advisory board meetings
  • Collaborate to identify program risks and implement mitigation strategies

Required qualifications

  • Medical Degree (M.D.) or other degrees considered with relevant experience
  • Residency training in Ophthalmology
  • 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 have

  • Subspecialty training in retina
  • Board certification
  • Retina fellowship training

About the company

4DMT is a late-stage biotechnology company advancing durable and disease-targeted therapeutics. The company's lead product candidate 4D-150 is designed for the treatment of blinding retinal vascular diseases.

Executive Medical Director (Retina Program) at 4dmoleculartherapeutics | JobZoey