Job Description

Raising CRO standards for innovation and delivery to help bring life-changing treatments to patients faster.

Fortrea is seeking a dedicated Europe remote based Medical Director or Senior Medical Director with deep expertise in Ophthalmology along with background in innovative therapies, including cell and gene therapy. The incumbent will provide medical leadership and oversight across all phases of development, including early-phase innovation and late-phase global programs. Responsible for supporting the development activities of proposed and ongoing projects in their area of expertise, as well as medical monitoring to assigned clinical studies.

We are particularly interested in candidates who have led or supported ophthalmology clinical programs and who are comfortable serving as the study physician, providing medical monitoring oversight (e.g., safety review, contribution to protocol development, including study design, endpoints and eligibility criteria) and working collaboratively with other project team members. In addition to strong scientific leadership, the role is expected to be highly client-facing with an increased business development component - requiring regular engagement at executive level, and the confidence and polish to represent Fortrea with senior client leaders, external partners, and other key stakeholders.

WHAT YOU WILL DO

• SME Cross-functional, scientific & technical contributions and interactions with Clients Medical teams, Project teams, Key Opinion Leader and at Principal Investigator/Site levels.
• Partner with clients and internal teams to support business development - shaping clinical/medical strategy for proposals, bid defenses, and client discussions.
• 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 Lead, Regional or Program 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.
• Provides 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.

YOU NEED TO BRING…

Qualifications (Minimum Required and preferred):

• MD Degree, with board certification in ophthalmology
• 3+ years of substantial knowledge of drug development and extensive clinical research experience within the pharmaceutical/CRO industry (or as a clinical trial investigator) in Ophthalmology
• Industry experience inclusive of clinical trials medical monitoring experience or other relevant clinical development/trial experience at a CRO, pharmaceutical company, regulatory agency preferred.
• Have current knowledge of drug development and relevant clinical research experience within the pharmaceutical/industry in Ophthalmology.
• Experience supporting ophthalmology clinical studies or programmes.
• Experience engaging with Sponsors, investigators, and project teams as a medical monitor or investigator.
• Strong communication skills and ability to operate effectively in a global environment.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Work Environment

• Work is primarily performed in a remote (home office) environment with routine use of standard office equipment (e.g., computer, phone, printer, and other electronic devices); however, occasional presence at a Fortrea office may be required.
• May require driving to site locations and 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.

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