Executive Director, Global Safety Strategy & Benefit Risk Management

About Us

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 develop treatments for rare, deadly diseases. Founded in 1996 by a family seeking a cure for their daughter’s pulmonary arterial hypertension (PAH), we now have six FDA-approved therapies treating PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD), and neuroblastoma, a rare pediatric cancer. Our near-term pipeline focuses on additional therapies for PAH and pulmonary fibrosis (PF). We are also working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant, aiming to eliminate the transplant waiting list and cure end-stage organ diseases.

About the Role

We are seeking an exceptional physician leader to join our Global Patient Safety organization as Executive Director, Global Safety Strategy & Benefit-Risk Management. This role provides strategic leadership for the scientific evaluation of product safety, benefit-risk assessment, pharmacovigilance strategy, and global safety governance across the United Therapeutics Pulmonary portfolio.

The ideal candidate is a strategic and influential safety leader with deep expertise in pharmacovigilance, clinical medicine, benefit-risk evaluation, regulatory science, and safety governance. This person will exercise substantial independent judgment in evaluating complex scientific and regulatory issues, balancing patient safety with business objectives, and influencing executive decisions with potential global regulatory impact.

Responsibilities

• Enterprise Safety Strategy:
  • Develop and execute the global safety strategy across investigational and commercial products throughout the product lifecycle for the pulmonary portfolio.
  • Establish scientific frameworks supporting benefit-risk assessment, safety surveillance, and risk minimization strategies.
  • Partner with executive leadership to integrate patient safety into corporate development, regulatory, and commercialization strategies.
  • Anticipate emerging scientific, regulatory, and business risks and proactively develop mitigation strategies.
• Benefit-Risk Leadership:
  • Provide executive oversight of benefit-risk assessments supporting global regulatory submissions, lifecycle management, safety governance committees, and health authority interactions.
  • Lead enterprise discussions regarding evolving product safety profiles and recommendations impacting development strategy and marketed products.
  • Ensure consistent application of benefit-risk principles across all therapeutic areas and product platforms.
  • Chair or participate in senior governance committees supporting product safety decision-making.
• Scientific Leadership:
  • Provide scientific leadership for signal detection, signal evaluation, aggregate safety assessments, literature surveillance, epidemiology, and safety science activities.
  • Oversee development of safety strategies supporting Risk Management Plans (RMP), REMS, PASS, PAES, and post-authorization safety commitments.
  • Ensure safety decisions remain evidence-based and scientifically defensible.
  • Guide complex medical evaluations requiring expert clinical judgment.
• Global Safety Governance:
  • Execute established governance frameworks supporting consistent safety decision-making across the organization.
  • Provide executive oversight for safety review committees including PSMT, PSRC, MARC, PLRC, DMC, and other governance forums.
  • Ensure alignment between Global Patient Safety, Clinical Development, Regulatory Affairs, Medical Affairs, Commercial, Manufacturing, Quality, and Business Development.
  • Drive enterprise inspection readiness for safety governance processes.
• Regulatory Safety Strategy:
  • Lead the pharmacovigilance strategy supporting global regulatory submissions, inspections, product approvals, and lifecycle management.
  • Represent Global Patient Safety during executive meetings with regulatory agencies.
  • Interpret evolving FDA, EMA, MHRA, PMDA, Health Canada, and international pharmacovigilance requirements.
  • Guide organizational implementation of new regulatory expectations impacting benefit-risk evaluation.
• Leadership of Brand Safety Organization:
  • Provide strategic leadership and direct oversight of Brand Safety Leads and Medical Safety Physicians aligned to each product.
  • Maintain executive oversight of products without dedicated Brand Safety Leads to ensure consistent scientific review and regulatory compliance.
  • Establish performance expectations and scientific standards across the Brand Safety organization.
  • Mentor physicians and safety leaders while developing future organizational capability.
• Cross-Functional Enterprise Leadership:
  • Serve as the senior safety representative supporting Product Development Teams.
  • Influence executive decisions regarding clinical development strategy, protocol design, safety monitoring, regulatory filings, due diligence, licensing opportunities, and lifecycle management.
  • Collaborate closely with Global Patient Safety Operations to ensure operational execution aligns with scientific strategy and regulatory expectations.
  • Partner with Alliance Management to ensure consistent safety oversight across affiliates, licensing partners, and commercial collaborators.
• Inspection Readiness and Compliance:
  • Maintain executive accountability for inspection readiness related to safety science, benefit-risk management, and safety governance.
  • Lead responses to complex regulatory inspections and significant safety findings.
  • Oversee corrective and preventive actions related to scientific or regulatory observations.
  • Ensure all safety activities comply with global pharmacovigilance regulations, ICH guidelines, GVP modules, FDA requirements, and international standards.
• Innovation and Organizational Strategy:
  • Drive innovation in pharmacovigilance through implementation of AI, advanced analytics, automation, and modern safety science methodologies.
  • Develop long-term organizational strategies supporting portfolio expansion, novel therapeutic platforms, medical devices, biologics, xenotransplantation, digital health technologies, and future product innovations.
  • Influence organizational structure, capability development, and resource planning to support continued business growth.
• Participate in medical conferences, presenting safety posters, white papers, and other safety publications.
• Perform other duties as assigned.

Requirements

• MD.
• 10+ years of leading Safety Risk Management organization in pharma or biopharma.
• 3+ years of managing other MDs or sub-investigators.
• 5+ years of clinical trial support, either as a principal investigator, sub-investigator, or development team membership.
• 3+ years of experience working in a matrix team environment, including supporting other team members when required.
• Ability to promote collegiality and teamwork among peers in a matrix environment.
• Proficient with MS Office suite (Word, Excel, Outlook, PowerPoint).
• Data analytics experience with tools such as Excel, patient listing reviews, dashboards, Spotfire, QlikView, etc.
• Ability to search a wide range of literature and clinical sources to collect evidence-based data and synthesize solid clinical conclusions.
• Excellent oral and written communication skills to support responses to Health Authority requests.
• Excellent interpersonal and time management skills to ensure compliance with firm timelines.
• Ability to think strategically, present independent, reasoned solutions to identified safety issues, and minimize risk to patients within the program or commercial therapy.
• Ability to influence internal and external stakeholders, reach consensus, and meet critical regulatory, safety, and business objectives.
• Demonstrated problem-solving skills that enact change and drive continuous improvement.
• Ability to be flexible, adaptable, and open-minded in a constantly changing environment.
• Ability to build and manage cross-functional relationships by motivating and inspiring others.
• Proactive, self-starter with ability to work under minimal direction.

Preferred Qualifications

• MD with Pulmonology specialty, USA practice, and Board Certification.
• 3+ years of clinical/medical practice experience within the US and/or full registration with a medical licensing body.
• MD - Physician - State Licensure.

Location and Travel

This position may be based out of our RTP, NC office on a hybrid schedule or located remotely in the continental United States. Relocation assistance may be available for non-local candidates. This role may require up to 15% travel.

Pay

The salary range for this position is $275,000 - $375,000 per year. An employee’s position within the salary range will be based on factors such as education, qualifications, experience, skills, geographic location, and business needs, as well as other factors permitted by law at the time of posting.

Benefits

Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including:

• Medical, dental, vision, and prescription coverage.
• Employee wellness resources.
• Savings plans (401k and ESPP).
• Paid time off and paid parental leave benefits.
• Disability benefits.

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