Senior Medical Director – MD

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide medical leadership for the execution of clinical trials.

• Assist in the development efforts for both proposed and ongoing initiatives in the pertinent area of expertise.

• Conduct medical monitoring for assigned clinical studies.

• Propel projects from a holistic company viewpoint, extending beyond the medical domain.

• Offer strategic and tactical subject matter expertise for client proposals, bid defenses, business development, quality/process enhancements, and audit activities.

• Contribute to the formulation of company policies regarding medical, safety, and therapeutics.

• Deliver cross-functional scientific and technical input while collaborating with client medical teams, project teams, key opinion leaders, and investigators/sites.

• Collaborate with GCO to cultivate new and strengthen existing client relationships.

• Engage in proposal teams and furnish medical/scientific capabilities to clients and internal teams.

• Conduct site/investigator feasibility assessments and establish relationships with investigators to aid recruitment and trial execution.

• Interact with study teams, functional groups, investigational sites, regulatory authorities, ethics committees, safety monitoring boards, and healthcare professionals.

• Support and engage in departmental recruitment initiatives.

• Provide leadership and showcase medical/scientific capabilities to clients.

• Manage, oversee, and delegate responsibilities to up to 5–10 direct and indirect reports as necessary.

• Act as Global, Regional, or Program Lead Project Physician across multiple indications as assigned.

• Offer drug development expertise and contribute to medical strategy and study/program execution.

• Review and update 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, as well as assist during site initiation visits.

• Provide medical and scientific insights to project teams.

• Conduct medical and safety monitoring and engage in project risk assessments.

• Perform medical data reviews and supervise central medical data reviews where applicable.

• Review and respond to safety alerts as necessary.

• Assist with the medical review of coding.

• Support activities related to data safety monitoring boards.

• Review medical monitoring scopes of work, hours, and budgets.

• Oversee medical monitoring tasks, timelines, and quality of deliverables, assigning physician resources as needed.

• Maintain subject matter expertise through Continuing Medical Education (CME), clinical work, and relevant conferences/meetings.

• Develop training modules and provide disease-area and protocol-specific training.

• Engage in process improvement initiatives.

• Represent the company at conferences and scientific gatherings.

• Lead therapeutic-area initiatives involving physicians across the corresponding therapeutic area.

• Perform additional duties as assigned.

⛳️ Requirements

• MD degree is required.

• MD/DO professional degree/designation/certification/license is legally required.

• Relevant subspecialty fellowship training and a history of board certification, as appropriate.

• Acknowledged as a clinical research leader with significant knowledge of drug development.

• Extensive clinical research experience within the pharmaceutical/industry in a specific therapeutic area, which may substitute for the board certification specialization, as applicable.

• Fortrea may consider relevant and equivalent experience in place of educational prerequisites.

• A minimum of 3–10 years of experience with in-depth knowledge of drug development and substantial 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 coverage as scheduled.

• Flexibility to attend meetings across various time zones.

• Occasional domestic and international travel may be necessary.

• Frequently stationary for 6 to 8 hours per day.

• Repetitive hand movements with both hands and the ability to perform quick, 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 utilize various computer software.

• Light to moderate lifting and carrying of items, including luggage and laptop computers, up to 15 to 20 pounds.

• Regular and consistent attendance is expected.

• 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.