Vice President, Clinical Development

General Summary
Reporting to the Chief Medical Officer, the VP, Clinical Development, Ophthalmology provides strategic and operational leadership for global development of ophthalmic genetic medicines.

Responsibilities
- Serve as primary medical monitor for multiple ophthalmology clinical trials; oversee patient safety, data integrity, and protocol adherence.
- Direct and mentor medical monitors; ensure timely delivery of critical trial outputs.
- Provide medical leadership for cross-functional workstreams (pharmacovigilance, biostatistics, clinical operations, regulatory affairs, etc.).
- Lead development planning and submissions (protocols/amendments, ICFs/IBs, INDs, annual reports, CSRs, regulatory response documents; and other regulatory documents as needed).
- Partner with Clinical Operations to ensure trial conduct and deliverable timelines.
- Ensure compliance with SOPs and adhere to ICH/GCP and relevant regulatory guidelines.
- Lead/support internal audits and regulatory inspections.
- Support Advisory Board/BOD materials.
- Lead interactions/collaborations with partners and key external stakeholders.
- Travel ~20%.

Qualifications
- MD.
- Clinical training in Ophthalmology (preferred); retina fellowship (plus); Board Certification (preferred).
- 8+ years biopharma drug development experience.
- Phase 3 ophthalmology experience; retinal disease highly preferred.
- Experience with NDA/BLA/MAA submissions (drug approvals a plus).
- Gene therapy experience (plus).

Skills (required/preferred)
- Strong communication, analytical/problem-solving, and strategic planning skills.
- Track record influencing senior leaders; experience presenting to regulatory authorities (US/EU/APAC).
- Strong knowledge of FDA/EMA/ICH/GCP.
- Team leadership and matrixed environment experience.

Compensation
- Base salary range: $350,000–$430,000.