Medical Director
4D Molecular Therapeutics
June 30, 2026
Remote friendly (United States)
United States
Medical Affairs
General Summary:
- The Medical Director will lead the design, execution, and analysis of clinical trials in the Ophthalmology therapeutic area, with a focus on retina programs.
Major Duties & Responsibilities:
- Lead clinical strategy and execution for ophthalmology trials (protocol development, study oversight, data interpretation).
- Serve as medical monitor to ensure patient safety and data integrity.
- Author and review clinical documents (protocols, IBs, ICFs, INDs, CSRs, regulatory submissions).
- Collaborate with cross-functional teams (clinical operations, regulatory, biometrics, safety, CMC, commercial).
- Engage external experts, organize advisory boards, and contribute to scientific/medical communications.
- Identify and mitigate clinical/programmatic risks.
- Support portfolio development and evaluation of new clinical opportunities.
- Represent the company in regulatory and scientific forums as needed.
Qualifications:
- Education: MD/OD/PhD/PharmD or equivalent; ophthalmology residency with preference for retina subspecialty; board certification a plus; retina fellowship training a plus.
- Experience: 5+ years clinical ophthalmology research in biopharma; experience with Phase 3 retina clinical trials; gene therapy experience a plus; other phases (1/2/4) a plus; NDA/BLA/MAA submission a plus; experience writing protocols and acting as a medical monitor; data analysis/interpretation and medical writing.
Skills/Other:
- Knowledge of ICH-GCP and FDA regulatory guidelines; international regulatory knowledge a plus; strong written/verbal communication.
Travel: 15%.
- The Medical Director will lead the design, execution, and analysis of clinical trials in the Ophthalmology therapeutic area, with a focus on retina programs.
Major Duties & Responsibilities:
- Lead clinical strategy and execution for ophthalmology trials (protocol development, study oversight, data interpretation).
- Serve as medical monitor to ensure patient safety and data integrity.
- Author and review clinical documents (protocols, IBs, ICFs, INDs, CSRs, regulatory submissions).
- Collaborate with cross-functional teams (clinical operations, regulatory, biometrics, safety, CMC, commercial).
- Engage external experts, organize advisory boards, and contribute to scientific/medical communications.
- Identify and mitigate clinical/programmatic risks.
- Support portfolio development and evaluation of new clinical opportunities.
- Represent the company in regulatory and scientific forums as needed.
Qualifications:
- Education: MD/OD/PhD/PharmD or equivalent; ophthalmology residency with preference for retina subspecialty; board certification a plus; retina fellowship training a plus.
- Experience: 5+ years clinical ophthalmology research in biopharma; experience with Phase 3 retina clinical trials; gene therapy experience a plus; other phases (1/2/4) a plus; NDA/BLA/MAA submission a plus; experience writing protocols and acting as a medical monitor; data analysis/interpretation and medical writing.
Skills/Other:
- Knowledge of ICH-GCP and FDA regulatory guidelines; international regulatory knowledge a plus; strong written/verbal communication.
Travel: 15%.