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.