Executive Director, Global Safety Strategy & Benefit Risk Management

United Therapeutics Corporation

North Carolina

Hybrid

USD 275,000 - 375,000

Full time

14 days+

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Benefits offered by this job

Medical / dental / vision coverage

Savings plans (401k and ESPP)

Paid time off & paid parental leave

Job summary

United Therapeutics Corporation is seeking an Executive Director to lead Global Safety Strategy and Benefit-Risk Management across the pulmonary portfolio. The role requires strategic judgment on safety surveillance, risk minimization, and regulatory interactions, with responsibility for governance across multiple product platforms.

The candidate will oversee Brand Safety Leads and Medical Safety Physicians, aligning scientific safety with corporate development and commercialization goals.

Qualifications

MD with licensure to practice in the US and relevant clinical background.
10+ years leading Safety Risk Management in pharma/biopharma.
3+ years managing MDs or sub-investigators.
MD Pulmonology Specialty, US practice and Board Certification preferred.

Responsibilities

Provide strategic leadership for pharmacovigilance, product safety and risk management.
Set enterprise safety strategy and governance across pulmonary portfolio and devices.
lead global safety governance committees and regulatory interactions
drive safety strategy integration with Clinical Development, Regulatory Affairs, Medical, and Commercial teams

Skills

Leadership

Pharmacovigilance

Cross-functional collaboration

Education

Board Certification

Job description

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

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 will provide strategic leadership for the scientific evaluation of product safety, benefit risk assessment, pharmacovigilance strategy, and global safety governance across the United Therapeutics Pulmonary portfolio. 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 judgement in evaluating complex scientific and regulatory issues, balancing patient safety with business objectives, and influencing executive decisions with potential global regulatory impact.

The Executive Director is responsible for establishing and executing the enterprise’s safety strategy supporting investigational and marketed products throughout the product lifecycle. This includes oversight of Brand Safety Leads/Medical Safety Physicians while ensuring scientifically robust safety surveillance, signal evaluation, regulatory compliance, and benefit risk management across all pulmonary portfolio, devices, biologics, combination products, and innovative development programs. As a recognized subject matter expert, the Executive Director collaborates extensively with Clinical Development, Regulatory Affairs, Medical Affairs, Biostatistics, Epidemiology, Quality, Commercial, Legal, Alliance Management, and Global Patient Safety Operations to influence critical business decisions that impact patient safety, regulatory strategy, and product development.

Enterprise Safety Strategy:

Develop and execute the global safety strategy across investigational and commercial products throughout the product lifecycle for 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 on establish 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

Other:

Participate in Medical Conferences, presenting safety posters, white papers & other safety publications
Perform other duties as assigned

Minimum Requirements

MD
10+ years of leading Safety Risk Management organization in pharma or biopharma
3+ years of managing other MDs or sub investigators

Preferred Qualifications

MD 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

Job Location and Travel

United Therapeutics has the flexibility to have this position 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 position may travel up to 15%.

The salary range for this position is $275,000 - $375,000 per year and reflects our good-faith estimate of the compensation for this role at the time of posting. 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. This range may be modified in the future based on company and market factors.

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