Senior Medical Director - Medical Monitoring

United Therapeutics Corporation•RTP, NC, NC

3d•$200,000 - $285,000•Hybrid

About The Position

This role supports groundbreaking science with the potential to transform the future for every individual on a transplant waiting list. It offers the opportunity to engage in work that inspired a career in medicine, joining a team that is advancing life-changing therapies for patients with rare and serious diseases while helping to shape the future of transplant medicine. The position offers the chance to make a meaningful impact, collaborate with exceptional colleagues, and thrive in a culture that values flexibility, balance, and well-being.

Requirements

MD, DO or Foreign Equivalent ie MBBS
7+ years of relevant experience, including either: (1) 7+ years of experience as a Medical Monitor in pharmaceutical product development within a pharmaceutical, biotechnology, or clinical research organization; or (2) clinical experience as a practicing physician treating patients in a relevant specialty combined with 2+ years of experience as a Medical Monitor supporting industry-sponsored clinical trials or clinical development programs
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
Clinical or medical monitoring experience in critical care, pulmonology, respiratory, nephrology, internal medicine, hospitalist or cardiologist or transplant

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).
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.
Provide medical advice and ensure that all medical questions raised during study conduct are answered appropriately and in a timely manner and documented in the TMF.
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.
Review the outputs of safety signal detection analysis and recommend appropriate remedial action when necessary to ensure the protection of subject safety.
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.
Participate in the overall review and approval of final study reports.
Document all medical monitoring activities and communications related to allocated studies.
Perform other duties as assigned and requested in support of clinical development program.