Senior Medical Director - Medical Monitoring (Clinical & Medical Affairs)

United Therapeutics • Rtp, NC

7h • Hybrid

About The Position

The Senior Medical Director - Medical Monitoring (UT Clinical & Medical Affairs) will 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). Will support strategic clinical product development as well as Global Medical Affairs. Provide medical expertise, advice, and guidance to clinical development project teams and study personnel as needed Maintain up ‑ to ‑ date knowledge of emerging therapies, clinical data, and the competitive landscape to inform study conduct and decision ‑ making Provide medical support for routine and urgent medical inquiries from internal and external study teams and sites, including on ‑ call support Conduct medical monitoring activities for assigned clinical studies and ensure appropriate documentation of all related activities and communications Participate in the review and approval of study protocols with focus on study design, scheduled assessments, and protection of subject safety Review and approve patient information leaflets and informed consent form templates for assigned studies Communicate complex scientific and clinical information with external stakeholders regarding patient eligibility, treatment decisions, study assessments, and subject safety Contribute to the drafting, review, and ownership of study ‑ specific medical monitoring plans Review study statistical analysis plans and draft data listings to ensure medical consistency of the data Provide clinical training for internal and external study team members and site personnel before and during study conduct Provide timely and appropriate medical advice to resolve medical questions arising during study execution Review serious adverse events, adverse events, clinical laboratory data, and safety signal detection outputs to identify potential safety concerns and recommend necessary actions to ensure subject safety Support Data Monitoring Committees, Data Safety Monitoring Boards, and clinical trial steering committees when constituted for a study Participate in ongoing review, interpretation, and overall approval of final study data and study reports Contribute to the management, generation, and dissemination of clinical and non ‑ clinical data resulting in high ‑ quality publications Develop and maintain professional relationships with external experts and support HCP interactions during conferences, symposia, and advisory boards Support internal and external educational initiatives, including medical education, data and guideline dissemination, and scientific communications and training Provide therapeutic knowledge support to the medical strategy team to inform development of innovative research concepts and clinical data generation addressing evidence gaps Work cross ‑ functionally to provide strategic medical and scientific leadership and partnership across the organization Perform other duties in support of clinical development programs as requested by United Therapeutics line management

Requirements

• MD including full registration with a medical licensing body such as the General Medical Council (GMC)
• 8+ years of experience as a medical monitor in pharmaceutical product development within a clinical research organization or pharmaceutical company
• MD - Physician - State Licensure
• Ability to make medical decisions for the study independently with oversight and guidance from the function head as needed; can act as primary MM on studies
• Competent end user of Microsoft Office software suite including Word/Excel/Outlook/PowerPoint
• Previous experience performing a clinical research role within a clinical research organization or pharmaceutical company
• Ability to travel up to 20%

Responsibilities

• 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).
• Support strategic clinical product development as well as Global Medical Affairs.
• Provide medical expertise, advice, and guidance to clinical development project teams and study personnel as needed
• Maintain up ‑ to ‑ date knowledge of emerging therapies, clinical data, and the competitive landscape to inform study conduct and decision ‑ making
• Provide medical support for routine and urgent medical inquiries from internal and external study teams and sites, including on ‑ call support
• Conduct medical monitoring activities for assigned clinical studies and ensure appropriate documentation of all related activities and communications
• Participate in the review and approval of study protocols with focus on study design, scheduled assessments, and protection of subject safety
• Review and approve patient information leaflets and informed consent form templates for assigned studies
• Communicate complex scientific and clinical information with external stakeholders regarding patient eligibility, treatment decisions, study assessments, and subject safety
• Contribute to the drafting, review, and ownership of study ‑ specific medical monitoring plans
• Review study statistical analysis plans and draft data listings to ensure medical consistency of the data
• Provide clinical training for internal and external study team members and site personnel before and during study conduct
• Provide timely and appropriate medical advice to resolve medical questions arising during study execution
• Review serious adverse events, adverse events, clinical laboratory data, and safety signal detection outputs to identify potential safety concerns and recommend necessary actions to ensure subject safety
• Support Data Monitoring Committees, Data Safety Monitoring Boards, and clinical trial steering committees when constituted for a study
• Participate in ongoing review, interpretation, and overall approval of final study data and study reports
• Contribute to the management, generation, and dissemination of clinical and non ‑ clinical data resulting in high ‑ quality publications
• Develop and maintain professional relationships with external experts and support HCP interactions during conferences, symposia, and advisory boards
• Support internal and external educational initiatives, including medical education, data and guideline dissemination, and scientific communications and training
• Provide therapeutic knowledge support to the medical strategy team to inform development of innovative research concepts and clinical data generation addressing evidence gaps
• Work cross ‑ functionally to provide strategic medical and scientific leadership and partnership across the organization
• Perform other duties in support of clinical development programs as requested by United Therapeutics line management

Benefits

• Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree