Chiesi Global Rare DiseasesChiesi Global Rare Diseases is a Chiesi Group's business unit established in February 2020 and focused on research, development and commercialization of treatments and patient support services for rare and ultra-rare disorders, many of whom have limited or no treatments available.
This unit is based in Boston, Massachusetts, with a strong synergy with the headquarters in Parma.
Rare unit has a focus on research and product development for lysosomal storage diseases, rare hematology, ophthalmology disorders and rare immunodeficiencies. The unit is also a dedicated partner with global leaders in scientific research, patient advocacy and care. Discover more here.
Who we are looking forThis is what you will doThe Global Head, Expanded Access Programs - Americas is responsible for the global strategic leadership, governance, and operational oversight of Expanded Access Programs across the United States, Canada, and Latin America, serving as the organization's senior subject matter expert and accountable leader for EAP activities within the region.
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.
The role will establish appropriate governance and operating standards, ensure compliant and consistent execution across countries, and proactively identify opportunities to improve patient access, operational efficiency, and the scalability of EAP programs.
The Global Head will also provide strategic input into product launches, lifecycle planning, portfolio strategy, and patient access initiatives, particularly where Expanded Access may be an important component of the overall medical strategy.
You'll be responsible for:- Global EAP Strategy & Leadership
- 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.
- Program Development & Oversight
- 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.
- Cross-Functional Leadership
- 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.
- Vendor & Financial Management
- 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.
- Operational Excellence & Innovation
- 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.
- External & Patient Access Leadership
- 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.
- Leadership & People Management
- 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.
You will need to have- Bachelor's or Master's degree in life sciences, healthcare, pharmacy, medicine, or related discipline required.
- Significant pharmaceutical, biotechnology, CRO, or healthcare industry experience.
- Significant leadership experience inExpanded 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.
- Demonstrated 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.
We would prefer for you to have- Experience with rare diseases and/or specialty pharmaceutical products.
LocationHybrid position based in Boston, MA. #LI-Hybrid
CompensationThe annual base pay for this position ranges from $164,000 to $226,000. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. If hired, the employee will be in an "at-will position" and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
What we offerNo matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way.
We provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support. Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive.
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