Medical Director - Medical Monitoring

California, US residentsclick 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.

The Medical Director - Medical Monitoring 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 members of the clinical development project teams as and when required
• 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
• Participate in 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
• Review serious adverse events (SAEs) that occur during studies as and 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 as and when deemed necessary to ensure the protection of subject safety
• Support the Data Monitoring Committee (DMC) / Data Safety Monitoring Board (DSMB) as and 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 in support of the clinical development programs as requested by United Therapeutics line management

Minimum Requirements

Job Location

This position will be located in the RTP, NC office of United Therapeutics. Currently this job is a hybrid role requiring at least three days per week in the office. In office requirements could increase based on business needs.

At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.

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.