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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive clinical research expertise and medical leadership within the pharmaceutical and biotechnology sectors, with a strong focus on drug development and Good Clinical Practice guidelines. Provides mentorship and strategic support while driving successful clinical development programs and fostering interdepartmental collaboration.
Highest-signal resume keywords
MD Or DO DegreeClinical Research LeadershipDrug Development ExpertiseGood Clinical Practice GuidelinesClinical Research Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial Protocol DevelopmentCase Report Form DesignData Safety MonitoringMedical MonitoringProject Risk AssessmentTraining Module DevelopmentAnalysis Plan DesignClinical Trial Report WritingFeasibility Discussion ParticipationMentorship and Guidance
Soft Skills
Interdepartmental CollaborationRelationship BuildingStrategic ThinkingMentoringCommunication
Tools & Technologies
In-House SoftwareOff-the-Shelf Software
Certifications & Qualifications
Board CertificationRelevant Subspecialty Fellowship TrainingMD/DO Professional Degree
Industry Keywords
Pharmaceutical IndustryBiotechnologyCROClinical ResearchTherapeutic Area
About the role
Key responsibilities & impact- Provide medical leadership and strategic support while partnering with clients and cross-functional teams
- Strengthen relationships and drive successful clinical development programs
- Provide oversight, mentorship, and guidance to team members
- Contribute to Global Clinical Operations initiatives
- Contribute to Company policies involving medical, safety, and therapeutics
- Participate in Company-wide process improvement activities
- Lead staff within the therapeutic area
- Lead initiatives involving physicians within and across the therapeutic area
- Contribute to the vision and strategic direction of the therapeutic area
- Develop training modules and materials and provide disease-state and protocol-specific training
- Participate in training on drug development and Good Clinical Practice guidelines
- Provide drug development expertise to medical strategy and execution of client programs
- Develop, review, and revise protocols, case report forms, training materials, project-specific tools, analysis plan designs, clinical trial reports, and new drug applications
- Provide medical and scientific expertise to project teams
- Act as Medical Monitor/study support for early clinical trials
- Perform medical and safety monitoring on assigned projects
- Interact with interdepartmental teams and external consultants
- Participate in feasibility discussions for project proposals
- Participate in project risk assessment activities
- Assist with Data Safety Monitoring Board activities when needed
- Provide clinical and medical expertise to other Fortrea departments
- Contribute to scientific and strategic leadership of a therapeutic area
- Perform other assigned duties and responsibilities
Requirements
What you’ll need- MD or DO degree required
- MD/DO professional degree/designation/certification/license legally required
- Relevant subspecialty fellowship training
- History of board certification, as appropriate
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements
- At least 10 years of experience; postgraduate training may be substituted by relevant expertise
- Recognized as a clinical research leader within the therapeutic area
- Substantial knowledge of drug development
- Extensive clinical research experience within the pharmaceutical, biotechnology, CRO, or clinical research industry
- Clinical research experience may be considered in lieu of board certification specialization where appropriate
- Legally authorized to work in the United States without current or future employer-sponsored work authorization
- Ability to access and use in-house and off-the-shelf computer software
- Regular and consistent attendance
- Varied hours may be required
- Ability to perform stated physical requirements, including stationary work, repetitive hand movements, occasional crouching/stooping, bending/twisting, and lifting 15–20 pounds
Benefits
Comp & perks- 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
- Occasional domestic and international travel opportunities
