Senior Medical Director - Medical Monitoring

United Therapeutics•Rtp, NC

1d•Hybrid

About The Position

United Therapeutics (Nasdaq: UTHR) is a publicly-traded biotech company focused on developing novel pharmaceutical therapies and technologies to address rare, deadly diseases and the shortage of transplantable organs. Founded in 1996, the company has developed six FDA-approved therapies for conditions like pulmonary arterial hypertension (PAH), pulmonary hypertension associated with interstitial lung disease (PH-ILD), and neuroblastoma. Their pipeline includes further therapies for PAH and pulmonary fibrosis (PF). United Therapeutics is also working on creating manufactured organs to eliminate transplant waiting lists and cure end-stage organ diseases. The Senior Medical Director, Medical Monitoring will play a crucial role in ensuring the safety of subjects and the scientific integrity of clinical studies for United Therapeutics Corporation (UTC) products, adhering to ICH GCP, regulatory guidelines, and company SOPs.

Requirements

MD and full registration with a medical licensing body (e.g., General Medical Council).
7+ years of experience as a medical monitor in pharmaceutical product development within a clinical research organization or pharmaceutical company, OR years of experience as a practicing clinician having served as principal investigator for federally-funded and/or industry-sponsored clinical trials.
MD - Physician - State Licensure.
Able to make medical decisions for the study independently and act as primary MM on studies.
Proficiency with Microsoft Office suite (Word/Excel/Outlook/PowerPoint).
Excellent communication skills, including a good overall scientific vocabulary.

Nice To Haves

Clinical and/or medical monitoring experience with PAH or cardiopulmonary, respiratory or relevant therapeutic area such as heart and/or kidney transplantation.

Responsibilities

Provide medical expertise, advice, and guidance to clinical development project teams.
Provide medical support for routine medical inquiries from 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 a focus on study design, scheduled assessments, and 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.
Provide medical advice and ensure all medical questions raised during study conduct are answered appropriately, in a timely manner, and documented in the TMF.
Review serious adverse events (SAEs) notified to Global Drug Safety to identify emergent safety concerns.
Review safety information, including adverse events and clinical laboratory data, during study conduct.
Review the outputs of safety signal detection analysis and recommend remedial actions.
Support the Data Monitoring Committee (DMC)/Data Safety Monitoring Board (DSMB) when constituted.
Review draft data listings, including coded data, for medical consistency.
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.