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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 be plan, execute, and supervise study oversight activities with guidance from Quality, Strategic Development Clinical Operations, and clinical execution team. Oversee the management and maintenance of metrics on department adherence to regulatory requirements and department standards to ensure department quality and consistency. Build effective relationships with internal and external customers and ensure continuous improvement in the conduct of clinical trial activities.

• Manage the development of and adherence to clinical oversight plans (Quality Management, Protocol Deviations, Vendor Oversight, etc.), including the oversight of vendors and contractors assigned to all UT studies
• Serve as lead to oversee risk-based quality management activities (RBQM), to include protocol risk assessment, quality tolerance limits and associated mitigation and management activities
• Prioritize and assign project goals ensuring tasks are completed and goals are met
• Administer and provide direction on established department policies, procedures, and objectives
• Identify cross functional process improvement activities and follow to resolution
• Manage the development and monitoring of reporting that highlights areas of concern and outlines investigations, action plans, and resolution
• Collaborate with strategic development clinical operations counterparts on the development and implementation of department Inspection Readiness plan
• Collaborate with GXP Compliance/QA to identify trends resulting from GXP Compliance/QA audits
• Support clinical team in preparing for inspections
• Facilitate GXP Compliance/QA audit activities for clinical development to include root cause analysis, corrective action preventative action (CAPA) and effectiveness checks using Quality Management System technology as appropriate
• Support provision and delivery of training concerning ICH, GCP, relevant UT-SOP’s, local regulations and guidelines
• Provide staff support by being a contact point for information and advice relating to ICH, GCP, relevant UT-SOP’s, local regulations and guidelines
• Support the design, development, and implementation of clinical training programs
• Support the development and implementation of clinical technology and analytics

For this role you will need

Minimum Requirements

• Bachelor’s Degree in a scientific discipline (preferred)
• 8+ years of relevant experience in pharmaceutical/biotech clinical oversight with a Bachelor's degree or
• 6+ years of relevant experience in pharmaceutical/biotech clinical oversight with a Master's degree
• Excellent understanding of the clinical research process, including US FDA, EU, and GCP regulations, and the function of quality control in clinical trial conduct
• Experience with developing SOPs and department processes
• Experience with clinical systems technology, e.g. EDC, CTMS and eTMF
• Excellent understanding of the clinical research process, including US FDA, EU, and GCP regulations, and the function of quality control in clinical trial conduct
• Experience with process improvement and CAPA management, including root cause analysis
• Strong time management with ability to multitask in a rapidly moving and changing environment
• Excellent organizational skills with attention to detail and accuracy in work
• Self-motivated with ability to lead teams and projects in a matrix environment
• Ability to build relationships and collaborate effectively within functional and cross-functional teams.
• Ability to work independently and as part of a team, handling high workloads and deadlines
• Proficiency with Microsoft Office Products and Email

Preferred Qualifications

• Master’s Degree in a scientific discipline (preferred)
• Experience as a CRA and/or Clinical Manager in the biopharmaceutical industry strongly preferred
• Experience with quality assurance audits
• Experience with clinical project management and/or clinical operations management
• Experience with risk assessment and management
• Experience with data analytics, and data manipulation

Job Location

This hybrid role is located in Durham, NC, and requires at least four in-office days a week. Expected travel for this role is up to 30%

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.