Senior Medical Director/Director, Clinical Development

Role Summary

Senior Medical Director/Director, Clinical Development (Medical Monitor) to be the primary sponsor medical person of contact for our clinical trials. This position reports to the VP, Clinical Development. This is a remote role.

Responsibilities

• Provide sponsor medical oversight for ophthalmology clinical trials
• Represent sponsor for emergency safety-related matters; in which CRO medical monitor would be primarily responsible
• 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 clinical development team; make recommendations for actions including protocol amendments and safety communications
• Participate in safety review meetings, including data monitoring committee; 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, IND annual reports, briefing packages); collaboratively prepare for meetings with FDA/EMA/global agencies

Qualifications

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

Education

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

Experience

• Minimum of 2–4 years’ experience in a CRO or biotech/pharmaceutical industry