Head of Expanded Access Programs, Americas, Global Rare Diseases

The role is responsible for developing and implementing the EAP strategy for the Americas in alignment with the broader Global Scientific Engagement & Innovation strategy and company priorities. The position provides strategic leadership across the full EAP lifecycle, including program feasibility, design, implementation, governance, operational execution, ongoing oversight, and program closure.

The Global Head will serve as a key strategic partner to senior Medical Affairs leadership and cross-functional stakeholders, including Regulatory, Pharmacovigilance, Quality, Supply Chain, Finance, Legal, Compliance, Clinical Development, Commercial, and other relevant functions.

Responsibilities

• Lead Expanded Access Program (EAP) strategy for the Americas, aligning with global and Medical Affairs priorities.
• Provide strategic direction for EAP activities across the U.S., Canada, and Latin America.
• Serve as the regional EAP subject matter expert and advisor to senior leadership.
• Establish EAP priorities, governance, operating principles, and strategic objectives.
• Partner with global leadership to evolve the EAP operating model and strategy.
• Contribute to portfolio planning, product launches, lifecycle management, and medical strategies impacting patient access.
• Lead evaluation, development, implementation, and oversight of EAP programs.
• Assess opportunities based on patient need, regulatory requirements, medical rationale, feasibility, risk, resources, and budget.
• Ensure appropriate governance and decision-making processes for EAP requests.
• Oversee program lifecycle management, including issue escalation and resolution.
• Ensure compliant processes for adverse event reporting, product complaints, and safety-related activities.
• Serve as the primary EAP partner to Medical Affairs, Regulatory, Pharmacovigilance, Quality, Supply Chain, Finance, Legal, Compliance, Clinical Development, and Commercial teams.
• Define roles, responsibilities, governance structures, and escalation pathways.
• Align patient access objectives with regulatory, compliance, quality, supply, and business requirements.
• Oversee EAP vendors, CROs, specialty pharmacies, distributors, and service providers.
• Lead vendor selection, contracting, performance management, and issue resolution.
• Manage Americas EAP budgets and ensure financial compliance.
• Drive cost efficiency, scalability, and operational effectiveness.
• Establish and monitor KPIs and communicate performance to leadership.
• Drive process standardization, automation, and continuous improvement initiatives.
• Implement innovative approaches to enhance operations and patient access.
• Leverage cross-country learnings to develop scalable solutions while meeting local requirements.
• Contribute to global policies, SOPs, governance frameworks, and operating standards.
• Maintain relationships with healthcare professionals, institutions, patient organizations, and other key stakeholders.
• Ensure participating sites have required protocols, documentation, and product information.
• Represent the company in external EAP forums and professional organizations as appropriate.
• Lead and develop the Americas EAP organization.
• Establish objectives, accountability, and performance expectations.
• Build organizational capabilities in Expanded Access, patient access operations, regulatory requirements, and vendor management.
• Collaborate with global EAP leaders to drive consistency and share best practices.
• Provide coaching, mentoring, and career development for team members.