VP Ophthalmic Clinical Development – Genetic Medicines

Regulatory Jobs; United States; À distance; USD 350 000 - 430 000; Plein temps

Résumé du poste

4DMT is seeking an experienced physician to lead global ophthalmic genetic medicines development. The VP Clinical Development will oversee medical monitoring, trial design, data interpretation, and regulatory document drafting (INDs, NDAs, BLAs, MAAs).

Responsibilities include collaboration with internal and external partners, ensuring timely deliverables, and guiding cross-functional teams through complex regulatory processes.

Qualifications

• MD degree with ophthalmology specialization and retina fellowship preferred.
• Phase 3 ophthalmology experience and NDA/BLA/MAA submissions are advantageous.
• Strong leadership in cross-functional teams and regulatory submissions.

Responsabilités

• Serve as medical monitor for ophthalmology trials with patient safety oversight.
• Mentor a team of medical monitors and oversee data review and trial outputs.
• Provide medical leadership across pharmacovigilance, biostatistics, clinical operations and regulatory affairs.

Connaissances

Medical oversight

Team leadership

Regulatory affairs

Strategic planning

Communication skills

Formation

MD Degree

Ophthalmology training

Retina fellowship training

Board Certification

Description du poste

4DMT is seeking an experienced physician to lead global ophthalmic genetic medicines development. The VP Clinical Development will oversee medical monitoring, trial design, data interpretation, and regulatory document drafting (INDs, NDAs, BLAs, MAAs).

Responsibilities include collaboration with internal and external partners, ensuring timely deliverables, and guiding cross-functional teams through complex regulatory processes.