Senior Medical Director - Medical Monitoring
About The Position
United Therapeutics (Nasdaq: UTHR) is a public benefit corporation dedicated to developing novel pharmaceutical therapies and technologies to improve patient lives. Founded in 1996, the company focuses on rare and life-threatening diseases, with 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 treatments for PAH and pulmonary fibrosis (PF). Additionally, United Therapeutics is working on creating manufactured organs to address the shortage of transplantable organs, aiming to eliminate transplant waiting lists and cure end-stage organ diseases.
Requirements
- MD and full registration with a medical licensing body (e.g., GMC).
- 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
- Ensure individual subject safety and the scientific integrity of studies during clinical development in accordance with ICH GCP, applicable regulatory guidelines, and company SOPs.
- Provide medical expertise, advice, and guidance to clinical development project teams.
- 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 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, timely, 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, to ensure 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.
Benefits
- Medical coverage
- Dental coverage
- Vision coverage
- Prescription coverage
- Employee wellness resources
- Savings plans (401k and ESPP)
- Paid time off
- Paid parental leave benefits
- Disability benefits
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What This Job Offers
Job Type
Full-time
Career Level
Senior
