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Senior Medical Director – Medical Monitoring
Foundation Finance Company LLCSenior Medical Director managing clinical development at United Therapeutics for rare diseases. Ensuring study integrity and subject safety during the clinical trials process.
Posted 7/11/2026full-timeRTP • North Carolina • 🇺🇸 United StatesSenior💰 $182,500 - $270,000 per yearWebsite
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Ensure individual subject safety and the scientific integrity of studies during the clinical development of United Therapeutics Corporation (UTC) products in accordance with ICH Good Clinical Practice (GCP), applicable regulatory guidelines and company standard operating procedures (SOPs)
- Provide medical expertise, advice, and guidance to members of the clinical development project teams as required and needed
- Provide medical support for routine medical inquiries for internal and external study teams and sites
- Provide on-call medical support for urgent medical inquiries
- Conduct medical monitoring activities for allocated clinical studies; including review and approval of study protocols with particular focus on study design, scheduled assessments, and protection of subject safety
- Review and approve all versions of the patient information leaflet and informed consent form templates
- Participate in the draft, review and ownership of study-specific medical monitoring plans (MMP)
- Review study statistical analysis plans
- Provide appropriate clinical training for internal and external study team members and site personnel as and when required before and during conduct of studies
- Review serious adverse events (SAEs) that occur during studies when they are notified to Global Drug Safety to assist in identifying any emergent safety concerns that may be related to study conduct
- Review safety information, including adverse events and clinical laboratory data during study conduct
- Support the Data Monitoring Committee (DMC)/Data Safety Monitoring Board (DSMB) when such a Committee is constituted for a study
- Review draft data listings, including coded data, provided by Data Management, to ensure medical consistency of the data
- Participate in the review and interpretation of study data
- Document all medical monitoring activities and communications related to allocated studies
Requirements
What you’ll need- MD and full registration with a medical licensing body such as the General Medical Council (GMC)
- 7+ years of experience as a medical monitor in pharmaceutical product development within a clinical research organization or pharmaceutical company or years of experience as a practicing clinician having served as principal investigator for federally-funded and/or industry sponsored clinical trials
- MD - Physician - State Licensure
- Able to make medical decisions for the study independently and can act as primary MM on studies
- Proficiency with Microsoft Office suite (Word/Excel/Outlook/PowerPoint)
- Excellent communication skills required including a good overall scientific vocabulary
Benefits
Comp & perks- medical / dental / vision / prescription coverage
- employee wellness resources
- savings plans (401k and ESPP)
- paid time off & paid parental leave benefits
- disability benefits
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Medical MonitoringStudy Protocol ReviewStatistical Analysis Plan ReviewAdverse Event ReviewClinical TrainingData InterpretationMedical Decision Making
Soft Skills
Excellent Communication
Certifications
Full Registration with Medical Licensing Body