Head of Expanded Access Programs, Americas, Global Rare Diseases

Chiesi Group • Boston, MA

7d • $164,000 - $226,000 • Hybrid

About The Position

The Head of Expanded Access Programs, Americas provides strategic leadership, governance, and operational oversight for Expanded Access Programs (EAPs) across the United States, Canada, and Latin America. The role serves as the senior regional subject matter expert and accountable leader for EAP activities, developing and implementing regional strategy in alignment with global Scientific Engagement & Innovation strategy and company priorities.

The position leads the full EAP lifecycle, from feasibility assessment and program design through implementation, governance, operational execution, ongoing oversight, issue resolution, and closure. It establishes governance and operating standards, ensures compliant and consistent execution across countries, and identifies opportunities to improve patient access, efficiency, and scalability. The role also contributes to product launches, lifecycle planning, portfolio strategy, and patient access initiatives.

As a senior cross-functional partner, the role works with Medical Affairs, Regulatory, Pharmacovigilance, Quality, Supply Chain, Finance, Legal, Compliance, Clinical Development, Commercial, and other teams. It oversees external vendors and regional budgets, drives operational excellence and performance measurement, represents the company in relevant external forums, and leads and develops the Americas EAP organization.

This is a hybrid position based in Boston, Massachusetts.

Requirements

• Bachelor’s or Master’s degree in life sciences, healthcare, pharmacy, medicine, or a related discipline.
• Significant experience in the pharmaceutical, biotechnology, CRO, or healthcare industry.
• Significant leadership experience in Expanded Access, Compassionate Use, Named Patient, or similar patient access programs.
• Demonstrated experience developing and executing EAP strategy across multiple countries.
• Strong understanding of U.S. Expanded Access requirements and international patient access frameworks.
• Ability to operate strategically with senior leadership and influence cross-functional stakeholders.
• Experience managing complex external vendors, contracts, and budgets.
• Strong understanding of Medical Affairs, Regulatory, Pharmacovigilance, Quality, Legal, and Compliance requirements.
• Demonstrated experience leading teams and complex programs across multiple geographies.
• Strong strategic, analytical, communication, negotiation, and project management capabilities.

Nice To Haves

• Experience with rare diseases and/or specialty pharmaceutical products.

Responsibilities

• Lead Americas Expanded Access Program strategy in alignment with global and Medical Affairs priorities.
• Provide strategic direction for EAP activities across the United States, Canada, and Latin America, and advise senior leadership as the regional EAP subject matter expert.
• Establish EAP priorities, governance, operating principles, and strategic objectives; collaborate with global leadership to evolve the operating model and strategy.
• Contribute to portfolio planning, product launches, lifecycle management, and medical strategies affecting patient access.
• Evaluate, develop, implement, and oversee EAP programs, assessing patient need, regulatory requirements, medical rationale, feasibility, risk, resources, and budget.
• Ensure appropriate governance and decision-making for EAP requests and oversee program lifecycle management, including escalation and resolution of issues.
• Ensure compliant processes for adverse-event reporting, product complaints, and safety-related activities.
• Partner with Medical Affairs, Regulatory, Pharmacovigilance, Quality, Supply Chain, Finance, Legal, Compliance, Clinical Development, Commercial, and other stakeholders; define roles, 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, including selection, contracting, performance management, and issue resolution.
• Manage Americas EAP budgets, ensure financial compliance, and drive cost efficiency, scalability, and operational effectiveness.
• Establish and monitor KPIs and communicate performance to leadership.
• Drive process standardization, automation, continuous improvement, and innovative approaches to enhance operations and patient access.
• Use 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 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, setting 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 promote consistency and share best practices; coach, mentor, and support team members’ career development.

Benefits

• Comprehensive healthcare programs.
• Work-life balance initiatives.
• Relocation support.
• Competitive salary package with performance bonuses and benefits benchmarked against the external market.
• Flexible working arrangements and remote work options.
• Tax assistance services for foreign colleagues.
• Resources and training to support employee development.

What This Job Offers

• Job Type: Full-time
• Career Level: Director