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Remote- US

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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 regulat...

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Executive Director, Global Safety Strategy & Benefit Risk Management