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 ophthalmology and cell gene therapy expertise to provide medical direction for the conduct of early clinical trials and support development activities and medical monitoring across assigned studies.

Responsibilities

• SME cross-functional, scientific & technical contributions and interactions with Client Medical teams, Project teams, Key Opinion Leader and at Principal Investigator/Site levels.
• Provide oversight of medical monitoring activities to ensure timelines and quality of medical deliverables and assigns 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 be 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.
• Prepare materials for and actively participate in investigator meetings and 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 training/degree and active US MD license / Board Certification required
• 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.

Work Environment

• Work is performed in an office environment with exposure to electrical office equipment.
• Occasional drives to site locations with occasional travel both domestic and international.

Physical Requirements

• Frequently stationary for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Regular and consistent attendance.
• Varied hours may be required.