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

California, US residents click here.

The job details are as follows:

Who We Are

We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.

United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter’s pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).

The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.

Who You Are

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