Senior Medical Director – MD

🔥 9 minutes ago

🇺🇸 United States – Remote

💵 $173k - $320k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.

📋 Description

• Provide medical direction for the conduct of clinical trials • Support development activities for proposed and ongoing projects in the relevant area of expertise • Perform medical monitoring for assigned clinical studies • Drive projects from an overall company perspective beyond the medical perspective • Provide strategic and tactical subject matter expertise for client proposals, bid defenses, business development, quality/process improvement and audit activities • Contribute to company policies involving medical, safety and therapeutics • Provide cross-functional scientific and technical contributions and interact with client medical teams, project teams, key opinion leaders and investigators/sites • Partner with GCO to develop new and enhance existing client relationships • Participate in proposal teams and provide medical/scientific capabilities to clients and internal teams • Perform site/investigator feasibility and build investigator relationships to support recruiting and trial conduct • Interact with study teams, functional groups, investigational sites, regulatory authorities, ethics committees, safety monitoring boards and healthcare professionals • Support and participate in departmental recruitment • Provide leadership and present medical/scientific capabilities to clients • Manage, supervise and delegate activities to up to 5–10 direct and indirect reports as applicable • Serve as Global, Regional or Program Lead Project Physician across multiple indications as assigned • Provide drug development expertise and contribute to medical strategy and study/program execution • Review and revise protocols, case report forms, training materials, project tools, analysis plans, clinical trial reports, data tables, listings, figures and new drug applications • Prepare materials for and participate in investigator meetings and assist at site initiation visits • Provide medical and scientific expertise to project teams • Conduct medical and safety monitoring and participate in project risk assessment • Perform medical data review and oversee central medical data review where applicable • Review and act upon safety alerts as required • Support medical review of coding • Assist with data safety monitoring board activities • Review medical monitoring scope of work, hours and budgets • Oversee medical monitoring activities, timelines and quality of deliverables, assigning physician resources as required • Maintain subject matter expertise through CME, clinical work and relevant conferences/meetings • Develop training modules and provide disease-area and protocol-specific training • Participate in process improvement activities • Represent the company at conferences and scientific meetings • Lead therapeutic-area initiatives involving physicians across the therapeutic area • Perform other duties as assigned

🎯 Requirements

• MD degree required • MD/DO professional degree/designation/certification/license legally required • Relevant subspecialty fellowship training and history of board certification, as appropriate • Recognized as a clinical research leader with substantial knowledge of drug development • 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 • A minimum of 3–10 years of experience with substantial knowledge of drug development and extensive clinical research experience within the pharmaceutical/CRO industry in a specific therapeutic area • Generally, 2–5 years of clinical trials medical monitoring experience or other relevant clinical development/trial experience at a CRO, pharmaceutical company, regulatory agency or clinical practice • Legally authorized to work in the United States without current or future employer-sponsored work authorization • Ability to provide out-of-hours and 24/7 emergency medical cover as scheduled • Flexibility to participate in meetings across various time zones • Occasional domestic and international travel may be required • Frequently stationary for 6 to 8 hours per day • Repetitive hand movement of both hands and ability to make fast, simple, repeated movements of the fingers, hands, and wrists • Occasional crouching and stooping, with frequent bending and twisting of the upper body and neck • Ability to access and use varied computer software • Light to moderate lifting and carrying of objects, including luggage and laptop computers, up to 15 to 20 pounds • Regular and consistent attendance • Varied hours may be required

🏖️ Benefits

• Medical insurance • Dental insurance • Vision insurance • Life insurance • Short-term disability (STD) insurance • Long-term disability (LTD) insurance • 401(k) • Paid Time Off (PTO) or Flexible Time Off (FTO) • Company bonus programs where applicable • Comprehensive benefits for regular full-time or part-time employees working 20 or more hours per week