Executive Director, Global Safety Strategy & Benefit Risk Management

United Therapeutics Corporation•RTP, NC, NC

10d•$275,000 - $375,000•Hybrid

About The Position

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. 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.

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

Nice To Haves

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

Responsibilities

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
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
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
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
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
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
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
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
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 & other safety publications
Perform other duties as assigned