Executive Director, Global Safety Strategy & Benefit Risk Management

United Therapeutics Corporation; Montpelier (VT); Hybrid; USD 275,000 - 375,000; Full time

Job summary

United Therapeutics Corporation seeks an Executive Director, Global Safety Strategy & Benefit-Risk Management to lead pharmacovigilance, safety governance, and risk management across the pulmonary portfolio. You will influence regulatory strategies, ensure safety surveillance, and collaborate with clinical development, regulatory, medical, and commercial partners.

The role requires MD level expertise, 10+ years in safety risk management, and strong leadership in a matrix environment in the

Qualifications

• MD is required.
• Board certification preferred.
• Experience leading safety risk management in pharma/biopharma is required.

Responsibilities

• Provide strategic leadership for safety strategies across investigational and marketed products.
• Oversee benefit-risk assessments for global regulatory submissions and lifecycle management.
• Lead governance committees and safety decision-making across product portfolios.
• Drive innovation in pharmacovigilance and safety science using modern analytics.

Education

MD

Board Certification

Tools

MS Office

Spotfire

QlikView

Job description

Hybrid

RTP, NC

Remote- US

Full time

R05236

California, US residents click here (https://www.unither.com/docs/UNITHER%20Applicant%20Notice%20-%20%2812-22-23%29%20Final%202.15.24%20Combined%20EN%20and%20French.pdf#page=9) .

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

• 5+ years of clinical trial support, either as a principal investigator or 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, working 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 wide range or literature and clinical sources to collect evidence-based data & synthesis 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, outside of the box and present independent, reasoned solutions to identified safety issues & minimizing risk to patients within the program or commercial therapy

• Ability to influence internal & external stakeholders, reach consensus, and meet critical regulatory, safety & 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 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 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.

We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success.

We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work.