Full-Time Medical Director, Ophthalmology

• Act as medical monitor in clinical ophthalmology studies with a focus on safety, data review and analysis of emerging data
• Contribute to study related documents including but not limited to study synopsis, protocols, amendments, ICFs, IBs, INDs, annual reports, CSRs, and other regulatory submissions and project-related documents.
• Accountable for the medical content of documents.
• Analyze, interpret, and organize data for presentations and publications
• Interact with external experts to gather input.
• Organize scientific advisory board meetings and data safety monitoring committee meetings
• Maintain a high level of clinical and scientific expertise in ophthalmologic disease area(s) by reviewing the literature and attending medical/scientific meetings
• Ability to communicate with Investigators and research site staff to ensure rigorous and compliant study conduct
• Able and willing to travel
• Other duties as assigned

• Education: Medical Degree (M.D.) with clinical experience. Clinical residency training in ophthalmology required.
• Experience: Experience with retinal disease, retinal imaging, or gene therapy. 5+ years of experience in clinical research in the pharmaceutical/biotech industry. Experience writing clinical research protocols and acting as a medical monitor preferred. Experience in multiple phases of clinical research (Phase 1-3) required. 4 yrs Phase III clinical research experience required
• Other Qualifications/Skills: Effective written and verbal communication skills. Knowledge of ICH-GCP and FDA regulatory guidelines. Knowledge of international regulatory requirements a plus. Able to work in a fast-paced, team-based environment; able to multitask and be a self-starter

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