Senior Medical Director - Medical Monitoring
United Therapeutics Corporation
August 23, 2026
Remote friendly (United States)
United States
Clinical Research and Development
Who You Are
The Senior Medical Director, Medical Monitoring will ensure individual subject safety and the scientific integrity of studies during clinical development in accordance with ICH GCP, applicable regulatory guidelines, and company SOPs.
Responsibilities:
- Provide medical expertise, advice, and guidance to clinical development project teams
- Provide medical support for routine and urgent medical inquiries for internal/external study teams and sites
- Conduct medical monitoring for allocated studies; review/approve study protocols focused on design, scheduled assessments, and subject safety
- Review and approve patient information leaflet and informed consent form templates
- Draft, review, and own study-specific medical monitoring plans (MMP)
- Review study statistical analysis plans
- Provide clinical training to internal/external study teams and site personnel
- Ensure medical questions are answered appropriately and documented in the TMF
- Review serious adverse events (SAEs) and emergent safety concerns with Global Drug Safety
- Review safety information (adverse events and clinical laboratory data)
- Review safety signal detection outputs and recommend remedial action
- Support DMC/DSMB when constituted
- Review draft data listings for medical consistency
- Participate in review/interpretation of study data and final study report approval
- Document all medical monitoring activities and communications; perform other assigned duties
Minimum Requirements:
- MD and full medical licensure
- 7+ years as a medical monitor in pharmaceutical development, or as a clinician/principal investigator on federally-funded and/or industry-sponsored clinical trials
- Ability to make independent study medical decisions and act as primary Medical Monitor
- Proficiency with Microsoft Office (Word/Excel/Outlook/PowerPoint)
- Excellent communication skills and scientific vocabulary
Preferred Qualifications:
- Clinical/medical monitoring experience in PAH or cardiopulmonary/respiratory/relevant therapeutic areas (e.g., heart/kidney transplantation)
Job Location & Travel:
- Durham, NC hybrid (3+ days/week) or remote within the continental US; travel up to 20%
The Senior Medical Director, Medical Monitoring will ensure individual subject safety and the scientific integrity of studies during clinical development in accordance with ICH GCP, applicable regulatory guidelines, and company SOPs.
Responsibilities:
- Provide medical expertise, advice, and guidance to clinical development project teams
- Provide medical support for routine and urgent medical inquiries for internal/external study teams and sites
- Conduct medical monitoring for allocated studies; review/approve study protocols focused on design, scheduled assessments, and subject safety
- Review and approve patient information leaflet and informed consent form templates
- Draft, review, and own study-specific medical monitoring plans (MMP)
- Review study statistical analysis plans
- Provide clinical training to internal/external study teams and site personnel
- Ensure medical questions are answered appropriately and documented in the TMF
- Review serious adverse events (SAEs) and emergent safety concerns with Global Drug Safety
- Review safety information (adverse events and clinical laboratory data)
- Review safety signal detection outputs and recommend remedial action
- Support DMC/DSMB when constituted
- Review draft data listings for medical consistency
- Participate in review/interpretation of study data and final study report approval
- Document all medical monitoring activities and communications; perform other assigned duties
Minimum Requirements:
- MD and full medical licensure
- 7+ years as a medical monitor in pharmaceutical development, or as a clinician/principal investigator on federally-funded and/or industry-sponsored clinical trials
- Ability to make independent study medical decisions and act as primary Medical Monitor
- Proficiency with Microsoft Office (Word/Excel/Outlook/PowerPoint)
- Excellent communication skills and scientific vocabulary
Preferred Qualifications:
- Clinical/medical monitoring experience in PAH or cardiopulmonary/respiratory/relevant therapeutic areas (e.g., heart/kidney transplantation)
Job Location & Travel:
- Durham, NC hybrid (3+ days/week) or remote within the continental US; travel up to 20%