- Serve as the primary medical monitor for multiple ophthalmology clinical trials, providing expert oversight of patient safety, data integrity, and protocol adherence.
- Direct and mentor a team of medical monitors to ensure high standards of medical oversight and real-time trial execution.
- Provide medical leadership for cross-functional internal workstreams including pharmacovigilance, biostatistics, clinical operations, and regulatory affairs.
- Lead teams responsible for development plans, study protocols, ICFs, IBs, INDs, CSRs, and other critical regulatory submissions.
- Collaborate with Clinical Operations to ensure clinical trial conduct and meeting project timelines.
- Provide medical leadership for internal audits and regulatory inspections.
- Represent the company and the Ophthalmology Therapeutic Area to external stakeholders, including patients, advocacy groups, and regulatory authorities.
- Assist in the preparation of materials for Advisory Board and Board of Directors meetings.
GCP