Senior Medical Director - Medical Monitoring

California, US residents  () .

** 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 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).

+ 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 programs

Minimum Requirements

+ MD and full registration with a medical licensing body such as the General Medical Council (GMC)

+ 7+ years of experience as a medical monitor in pharmaceutical product development within a clinical research organization or…