Head of Expanded Access Programs, Americas, Global Rare Diseases

Chiesi Farmaceutici•Boston, MA

5d•Hybrid

About The Position

The Head of Expanded Access Programs (EAP), Americas, provides strategic leadership, governance, and operational oversight of Expanded Access Programs across the United States, Canada, and Latin America. The role serves as the regional senior 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, oversight, and closure. It partners with senior Medical Affairs leadership and functions including Regulatory, Pharmacovigilance, Quality, Supply Chain, Finance, Legal, Compliance, Clinical Development, and Commercial. The role establishes governance and operating standards, supports compliant and consistent country-level execution, and identifies opportunities to improve patient access, efficiency, and scalability. The Head also provides strategic input to product launches, lifecycle planning, portfolio strategy, and patient access initiatives. Responsibilities include overseeing vendors and budgets, monitoring program performance, improving processes, engaging external stakeholders, and leading and developing the Americas EAP organization. The position is hybrid and 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; partner with global leadership to evolve the operating model and strategy.
Contribute to portfolio planning, product launches, lifecycle management, medical strategies, and patient access initiatives.
Lead evaluation, development, implementation, and oversight of EAP programs, assessing patient need, regulatory requirements, medical rationale, feasibility, risk, resources, and budget.
Ensure appropriate governance and decision-making for EAP requests, oversee program lifecycle management, and manage issue escalation and resolution.
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, responsibilities, governance structures, and escalation pathways, aligning 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 financial compliance while driving cost efficiency, scalability, and operational effectiveness.
Establish and monitor KPIs and communicate program performance to leadership.
Drive process standardization, automation, continuous improvement, and innovative approaches that enhance operations and patient access.
Apply cross-country learnings to develop scalable solutions while meeting local requirements, and 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.