Medical Director/Senior Medical Director - Ophthalmology US REMOTE based

Role Summary

Medical Director/Senior Medical Director with ophthalmology focus, US remote-based. Responsible for medical direction of early clinical trials and supporting development activities within their area of expertise, including medical monitoring of assigned studies.

Responsibilities

• SME cross-functional scientific and technical contributions and interactions with client medical teams, project teams, key opinion leaders, and investigators.
• Provide oversight of medical monitoring activities to ensure timelines and quality of medical deliverables; assign physician resources as required.
• May serve as Global, Regional, or Program Lead Project Physician across multiple indications, as scope allows.
• Provide subject matter and drug development expertise; contribute to the medical strategy and execution of studies/programs for the client.
• Input, review, and revision of protocols, case report forms, training materials, project-specific tools, analysis plans, clinical trial reports, and new drug applications.
• Prepare materials for and participate in investigator meetings; assist at site initiation visits.
• Provide medical/scientific expertise to the project team.
• Other duties as required or assigned.

Qualifications

• MD degree, relevant specialty/sub-specialty fellowship, and active US MD license; board certification required.
• 3+ years of substantive knowledge of drug development and extensive clinical research experience within the pharmaceutical/CRO industry in a specific therapeutic area (preferred).
• Industry experience including clinical trials medical monitoring or other relevant clinical development/trial experience at a CRO, pharmaceutical company, regulatory agency, or clinical practice (preferred).
• Recognized as a clinical research leader with substantial knowledge of drug development and extensive clinical research experience; board certification specialization may be substituted as appropriate.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Skills

• Medical direction and monitoring of early-phase clinical trials
• Strategic and operational contribution to drug development programs
• Protocol and tool development; analyses and trial reporting
• Investigator engagement and site initiation support
• Cross-functional collaboration with medical, project, and leadership teams

Education

• MD degree; relevant specialty/sub-specialty fellowship

Additional Requirements

• Occasional travel to site locations domestically and internationally
• Office environment with standard equipment; ability to work remotely