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Durham, North Carolina, United States
Remote only
Not Available
Fortrea is seeking a Senior Medical Director to provide medical direction for the conduct of clinical trials. Responsible for supporting the development activities of proposed and ongoing projects in their area of expertise, as well as medical monitoring assigned clinical studies. Partners with GCO to develop new and to enhance existing client relationships. Provides medical/scientific capabilities to clients and as part of the proposal teams and to internal teams where necessary.
Key / Core Responsibilities
• Ability to drive projects outside medical perspective i.e., understanding the overall company perspective.
• High level global and/or regional strategic and tactical Subject Matter Expertise (SME) input to Client Proposal, Bid Defence & Business Development as well as supporting continuous departmental Quality and Process Improvement activities and audit activities.
• Contributes to the development of Company policies involving medical,safety, and herapeutics.
• SME Cross-functional, scientific & technical contributions and interactions with Client Medical teams, Project teams, Key Opinion Leader and at Principal Investigator/Site levels.
• 24/7 availability at the designated time as per the TA specific 24-Hour emergency medical cover rotation.
Client Relationship & Business Development Activities
• Partnering with GCO to develop new and enhance existing client relationships where possible. Provides medical/scientific capabilities to clients as a participant of a proposal team.
• Performs site/investigator feasibility, builds relationships with investigators to support optimal recruiting and conduct of trials.
• Flexibility to participate in client/internal meetings across various time zones as needed to deliver business assignments.
• Directly interacts with:
Internal and external study team members: other Project Physicians/Medical
Monitors, Project Leader/Project Management, Clinical Lead, Clinical Research
Associates, Data Manager, Statistician, Medical Data Reviewer, Drug Safety
Representative, Adjudication Representative, Medical Cover Coordinator and other roles as appropriate.
o Other functional groups representatives during contribution to internal and client related processes and initiatives.
o Investigational Sites.
o Regulatory Authorities, Ethics Committees.
o Safety Monitoring Boards members.
o Health Care Professionals including Key Opinion Leaders in the relevant TA.
Managerial
• Supports and participates in the recruitment process for department positions.
• Provides leadership and presents medical/scientific capabilities to clients as a participant of a proposal team.
• May be responsible for managing, supervising and delegating activities to staff of up to 5 – 10 Direct and Indirect Reports.
Therapeutic and Scientific Expertise:
• According to the scope of work, may serve as Global, Regional or Program Lead Project Physician across multiple indications.
• Provides 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 materialsfor and actively participates in investigator meetings and assists at site nitiation visits.
• Provides medical/scientific expertise to project teams.
• Responsible for medical and safety monitoring on assigned projects. Participates in project risk assessment activities.
• Interacts with inter-departmental and external consultants as appropriate.
• Participates in feasibility discussions relating to specific project proposals. Leverages known, and builds new,relationships with investigators/sitesto perform site/investigator feasibility an support optimal recruiting and conduct of trials.
• Participates in project risk assessment activities.
• Provides out of hours medical cover as required.
• Performs medical data review; provides evaluation and oversight of medical data review performed by central medical data reviewers, if applicable.
• Reviews and, ifrequired, acts upon safety alerts (e.g. laboratory, ECG, SAE/adverse events of special interest).
• Supports medical review of coding.
• Develops, reviews and revises protocol, case report forms, training materials, project specific
tools, analysis plans design, clinical trial reports, data tables, listings and figures as needed and
new drug applications.
• Assists when needed with data safety monitoring board activities.
• Provides clinical and medical expertise to other Company departments.
• Reviews and/or assists with medical monitoring scope of work/hours and budget discussions as
required for new proposals and assigned studies.
• Provides oversight of medical monitoring activities to ensure timelines and quality of medical deliverables and assigns physician resources as required.
• Maintains subject matter expertise through ongoing continuing medical education (CME) or clinical work as well as attendance at relevant conference/meetings.
• Develops training modules and materials as required, and provides training in disease areas and protocol specific requirements across the company. May participate in training opportunities to
advance knowledge of drug development and good clinical practice guidelines.
• Interacts with interdepartmental and external consultants as appropriate.
• Participates in process improvement activities across Company.
• Presents or serves on panels to represent the company at conferences and scientific meetings.
• Leads initiatives that impact the TA and involves physicians within the TA and across the TA.
• Performs other duties as assigned.
Required Qualifications
· MD degree required.
· Professional degree/designations/certifications/licenses legally required: MD/DO.
· Relevant subspecialty fellowship training and history of board certification, as appropriate.
· 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.
· 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
· Of which 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
To be considered for this position, candidates must be legally authorized to work in the United States without the need for current or future employer-sponsored work authorization. Fortrea is unable to provide visa sponsorship or assume sponsorship of employment visas for this position.
Work Environment
· Work is performed in an office environment with exposure to electrical office equipment.
· Occasional domestic and international travel may be required.
Physical Requirements
· Frequently stationary for 6 to 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 and stooping, with frequent bending and twisting of the 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 moving) objects, including luggage and laptop computers, with a maximum lift of 15 to 20 pounds.
· Regular and consistent attendance.
· Varied hours may be required.
Pay Range
USD $173,000 - $320,000 annually
Benefits
All job offers will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, internal equity, and market data. Regular full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits, including Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), and Company bonus programs where applicable.
Application Deadline: 10/10/26
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