Medical Director/Senior Medical Director - Ophthalmology US REMOTE based

Role Summary

Medical Director/Senior Medical Director - Ophthalmology US REMOTE based. Fortrea is seeking a dedicated US remote based Medical or Senior Medical Director with therapeutic expertise in ophthalmology and background in cell gene therapy. The role provides medical direction for the conduct of early clinical trials and supports development activities and medical monitoring of assigned studies.

Responsibilities

• SME cross-functional, scientific and technical contributions with Client Medical teams, Project teams, Key Opinion Leaders and at Principal Investigator/Site levels.
• 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, depending on scope.
• Provide subject matter and drug development expertise; contribute to medical strategy and execution of the study/program for the client.
• Provide 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 actively participate in investigator meetings and assist at site initiation visits.
• Provide medical/scientific expertise to the project team.
• Any other duties as required or assigned.

Qualifications

• MD degree with relevant specialty/sub-specialty fellowship training; active US MD license and board certification required.
• 3+ years of substantial 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 clinical research experience in the pharmaceutical/industry; board certification specialization may be substituted as appropriate.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Work Environment

• Office environment with exposure to electrical office equipment.
• Occasional travel to site locations, with domestic and international travel.

Physical Requirements

• Frequently stationary for 6-8 hours per day.
• Repetitive hand movements with the ability to perform fast, simple, repeated movements of fingers, hands, and wrists.
• Occasional crouching, stooping, with frequent bending and twisting of the upper body and neck.
• Ability to use computer software developed in-house and off-the-shelf.
• Light to moderate lifting and carrying objects including luggage and laptop up to 15-20 lbs.
• Regular and consistent attendance; varied hours may be required.