Senior Medical Director/Director, Clinical Development

Role Summary

Senior Medical Director/Director, Clinical Development (Medical Monitor) is the primary sponsor medical contact for ophthalmology clinical trials, reporting to the VP of Clinical Development. This remote role oversees medical monitoring and safety, drives collaboration across pharmacovigilance, clinical operations, and data teams, and supports regulatory interactions.

Responsibilities

• Provide sponsor medical oversight for ophthalmology clinical trials
• Represent sponsor for emergency safety-related matters; CRO medical monitor may take primary responsibility in such events
• Conduct medical monitoring, coding, and data cleaning in collaboration with other functions; provide medical expertise during data listing reviews
• Monitor safety data from ongoing clinical trials, including adverse events, laboratory abnormalities, and other safety signals
• Evaluate safety data with pharmacovigilance and the clinical development team; recommend actions such as protocol amendments and safety communications
• Participate in safety review meetings (including data monitoring committees) and contribute to safety reporting requirements
• Review clinical trial data, including efficacy endpoints, biomarkers, and imaging data
• Contribute to and review eCRFs and CRF completion guidelines
• Review clinical trial protocols, investigator brochures, and other study-related documents
• Support site investigators and study teams with protocol implementation, training, and ongoing medical guidance
• Support or prepare data interpretation and clinical trial reports
• Assist in preparation of clinical sections of regulatory documents (INDs, annual reports, briefing packages) and collaborate for meetings with FDA/EMA/global agencies

Qualifications

• Required: Relevant work experience in medical monitoring and/or pharmacovigilance and/or drug safety in a CRO, pharmaceutical, or clinical trial environment
• Required: Strong understanding of clinical trial design, methodology, and regulatory requirements
• Required: Knowledge of ophthalmic diseases, treatments, and diagnostic techniques
• Preferred: Experience with ophthalmic imaging modalities (e.g., OCT, fundus photography)
• Required: Familiarity with Good Clinical Practice (GCP) guidelines and ethical principles governing human subjects research
• Preferred: Experience in monitoring retinal trials and phase 3 global trials

Education

• Medical degree (MD, DO, or equivalent) with specialization in Ophthalmology