Medical Director/Senior Medical Director - Ophthalmology US REMOTE based

Role Summary

Remote-based US Medical Director/Senior Medical Director with ophthalmology expertise and background in cell gene therapy. The incumbent will provide medical direction for the conduct of early clinical trials and support the development activities of proposed and ongoing projects in their area of expertise, as well as medical monitoring assigned clinical studies. This role aims to raise CRO standards for innovation and delivery to bring life-changing treatments to patients faster.

Responsibilities

• SME cross-functional, scientific & technical contributions and interactions with client medical teams, project teams, key opinion leaders, and principal investigators/sites.
• Provide oversight of medical monitoring activities to ensure timelines and quality of medical deliverables and assign physician resources as required.
• According to the scope of work, may serve as Global, Regional or Program Lead Project Physician across multiple indications.
• Provide subject matter and drug development expertise and is a key contributor to the 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 design, clinical trial reports and new drug applications.
• Prepares materials for and actively participates in investigator meetings and assists at site initiation visits.
• Provides medical/scientific expertise to project team.
• And any other duties as required or assigned.

Qualifications

• Required: MD Degree, relevant specialty/sub-specialty fellowship training/degree and active US MD license / Board Certification required
• Preferred: 3+ years substantial knowledge of drug development and extensive clinical research experience within the pharmaceutical/CRO industry in a specific therapeutic area
• Preferred: Industry experience inclusive of clinical trials medical monitoring experience 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 within the pharmaceutical/industry in a specific therapeutic area, which can be a substitute for the board certification specialization, as appropriate
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Skills

• Cross-functional collaboration with medical teams, project teams, and investigators
• Medical monitoring oversight and resource management
• Drug development strategy and execution for studies/programs
• Protocol, case report form, and analysis plan review and design
• Investigator meetings and site initiation visits
• Medical/scientific expertise to project teams