Clinical Oversight Lead II

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

You will provide operational and quality oversight across United Therapeutics (UT) clinical programs, ensuring high-quality execution, vendor compliance, and continuous improvement of clinical processes. In the role, you will play a key part in strengthening quality by design and proportionate risk management, enabling inspection readiness, and supporting cross‑functional teams in delivering high‑integrity clinical trial data.

• Develop and execute clinical oversight plans (Quality Risk Management, Protocol Deviations, Vendor Oversight, etc.) across all UT studies
• Partner with cross-functional teams, including Clinical Operations, Data Management, Stats, Safety and Medical Monitoring, to facilitate alignment with critical-to-quality factors and regulatory guidelines
• Conduct ongoing risk surveillance through analysis of quality metrics, KPIs, and KRIs across study conduct, vendor performance, and protocol compliance, providing actionable insights and recommendations to study teams
• Lead the end‑to‑end management of the protocol deviations process, including planning, documentation, trend analysis, and clinical study report input, and chair cross-functional reviews to ensure timely mitigation and prevention of recurrence
• Perform targeted, risk-based on‑site quality oversight visits and training, and escalate when potential important quality or compliance issues are identified
• Evaluate compliance with internal SOPs and ICH/GCP requirements, including planning, facilitation, and documentation of internal Clinical Development process reviews
• Support ongoing oversight of clinical vendors to ensure compliance with contractual, procedural, and regulatory expectations, including issue identification, escalation, and follow‑up
• Manage quality management system documentation and tracking for all Clinical Development
• Partner with functional leads to ensure timely investigation of quality events and important issues, including root cause analysis, risk evaluation, development and implementation of appropriate CAPAs, and verification of effectiveness to prevent recurrence
• Facilitate site-audit responses for Clinical Development in partnership with cross-functional teams
• Support GCP regulatory inspection readiness and inspection execution, including back-room support with inspection responses, CAPAs, and effectiveness checks
• Design, develop, and support the delivery of clinical training based on findings from clinical oversight activities, audits, inspections, evolving regulations, and quality risks
• Lead or contribute to initiatives aimed at optimizing clinical oversight processes, risk reduction, compliance improvement and inspection readiness
• Maintain regulatory intelligence and proactively communicate emerging GCP, ICH, FDA and industry regulatory expectations to Clinical Development, ensuring teams remain informed, aligned, and inspection‑ready

Minimum Requirements

• Bachelor's Degree in a relevant field, preferably a science-related field
• 8+ years of experience in biopharmaceutical research & development or CRO
• Experience with developing SOPs and department processes
• Experience with training and mentoring clinical research staff
• Experience with Clinical systems technology, e.g. EDC, CTMS, eTMF
• Experience with quality assurance audits
• Experience with risk assessment and management
• Experience with data analytics, and data manipulation
• Experience with process improvement and CAPA management, including root cause analysis

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. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities

United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.