Executive Medical Director, Retina Program
New
4
4D Molecular TherapeuticsBiotechnology
Remote, United StatesFull-TimeDirector
Salary350,000 - 398,000 USD per year
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Job Details
- Experience
- 10+ years
- Required Skills
- Data Analysis
Requirements
- Medical Degree (M.D.); other degrees considered with relevant experience.
- Residency training in Ophthalmology; retina subspecialty training preferred.
- 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 Phase 2/3 clinical research.
- Experience with NDA/BLA/MAA submission planning and execution.
- Expertise in data analysis, interpretation, and medical writing.
- Knowledge of ICH-GCP and FDA regulatory guidelines.
- Ability to travel up to 20%.
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.
- Serve as medical monitor for assigned studies, ensuring subject safety and data integrity.
- Lead cross-functional study teams to ensure high-quality and timely trial delivery.
- Lead development and implementation of biomarker strategies for retina programs.
- Author development plans, protocols, IBs, INDs, CSRs, and regulatory responses.
- Organize and lead scientific advisory board meetings and engage with external experts.
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