Senior Director, Corporate Compliance – Data Operations

United Therapeutics Corporation
1dRemote

About The Position

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. You are a forward-thinking architect of compliance processes and data ecosystems. You like working closely with business stakeholders within Compliance and across the organization to improve processes and shape how information flows and decisions are made. You liked to transform complex data into clear, actionable intelligence that powers risk‑based decision‑making, effective and efficient business processes, and meaningful insights that strengthen the entire compliance program. You enjoy partnering closely with cross-functional stakeholders – including Finance, IT, Legal, Clinical, Commercial, and Medical – to improve business processes and systems.

Requirements

  • 15+ years of experience in the life sciences industry (e.g., pharmaceutical, medical device, or biotech) with a Bachelor's Degree in business, finance, life sciences or healthcare
  • 13+ years of experience in the life sciences industry (e.g.. pharmaceutical, medical device, or biotech) with a Master's Degree
  • 8+ years of experience related to people management
  • Demonstrated knowledge of regulatory/compliance requirements, including Anti-Kickback Statute, False Claims Act, government pricing regulations, and state price transparency laws and regulations
  • Ability to build and maintain professional relationships with internal stakeholders
  • Ability to work in a fast-paced environment while demonstrating flexibility, commitment to teamwork, and a willingness to adapt assignments to meet the Company's needs
  • Acts with a sense of urgency, with high motivation and ability to take initiative, follow through and complete projects in a professional and expeditious manner
  • Strong presentation skills, including creating and delivering presentations to various size audiences at all levels of the organization
  • Strong analytical, problem-solving, collaborative, and interpersonal skills
  • Strong attention to detail and accuracy
  • Excellent communication skills, including robust and advanced documentation practices
  • Microsoft Office proficiency with Word, Excel and PowerPoint
  • Handles confidential matters with discretion and solid judgment
  • Produces high quality work with minimal oversight from manager
  • Candidates RTP based must have the ability to travel up to 20%
  • Candidates not RTP based must have the ability to be onsite in RTP for 1 week per month, in addition to standard business travel as needed for the position

Nice To Haves

  • Master’s Degree in business, finance, life sciences or healthcare

Responsibilities

  • Develop and execute a comprehensive compliance system and data strategy that aligns with corporate priorities and regulatory expectations
  • Establish and maintain dialogue with the executive team and other stakeholders to effectively communicate, guide, and coach on Compliance program developments related to the area of responsibility
  • Promote with stakeholders a proactive approach to compliance that is focused on partnerships, prevention, and risk mitigation
  • Identify and respond to compliance challenges in a thoughtful, solutions-oriented, and timely manner, in alignment with Compliance best practices
  • Assist with the development of reporting to the Compliance Committee and to the Board of Directors
  • Oversee transparency program operations, including oversight of the vendor responsible for data collection, cleansing, staging, reporting, and system maintenance.
  • Ensure timely and accurate reporting of US and OUS transfers of value to HCPs, teaching hospitals, and investigators leading UT clinical studies
  • Escalate and remediate data quality challenges that impact transparency reporting and compliance operations, as needed
  • Incorporate feedback from auditing, monitoring, and business stakeholders to drive enhancements to systems and data
  • Oversee the design, management, and maintenance of transparency reporting systems
  • Collaborate with business stakeholders across relevant business units to provide feedback on systems and data that support or complement compliance operations
  • Ensure timely and accurate reporting to support monitoring, auditing, investigations, and regulatory inquiries
  • Translate complex data into clear insights and recommendations for executive leadership and stakeholders
  • Oversee the design, management, and maintenance of systems enabling compliance processes (e.g., HCP Engagement, External Funding, Fair Market Value, etc.) and other compliance databases, dashboards, and reporting tools
  • Collaborate with business stakeholders across relevant business units to provide feedback on systems and data that support or complement compliance operations
  • Oversee the design, development, execution, and maintenance of a third-party risk management program for healthcare compliance risk.
  • Partner with Finance, specifically Procurement, to ensure compliance controls are incorporated into broader third-party management and procurement processes
  • Oversee the development and maintenance of the department budget
  • Raise awareness of the Compliance program and foster department and org-wide accountability for compliance
  • Maintain effective rapport with other staff members, client professional support staff, and administrators
  • Direct and manage direct reports to include responsibilities for training, goal setting & achievement, performance evaluations/management, coaching, mentoring, career development, and provide support for recruitment process (as needed)

Benefits

  • 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
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