Director, Expanded Access Program Operations
Job description
This role is responsible for architecting and overseeing the global Expanded Access Program (EAP) system, ensuring seamless operations from patient intake to implementation. You will integrate Program Management and Site Management into a unified, scalable model that maintains rigorous quality and compliance standards. The Director of EAP Operations will apply an entrepreneurial mindset to optimize processes and remove obstacles in treatment access. You will balance patient-first values with commercial awareness to navigate complex healthcare landscapes. This position is suited for leaders who manage complexity and develop high-performing teams under pressure. You will serve as a strategic partner to BioPharma clients and internal stakeholders. The role requires resilience and speed in delivering solutions for patients in need. You will shape the future of treatment access through operational excellence and innovation.
About the role
The Director of EAP Operations will oversee the end-to-end operating model for EAP Program and Site Management to ensure scalable and compliant delivery across global markets. You will convert strategy and portfolio forecasts into detailed capacity plans, organizational design frameworks, and prioritized hiring initiatives. The role involves developing resilient coverage and escalation models to eliminate single points of failure and maintain continuity. You will lead the EAP Program Management team to drive consistent execution across diverse clients and geographic regions. You will also lead the EAP Site Management team to strengthen site engagement, balance workloads, and uphold service performance standards. Driving standardization and continuous improvement in workflows, tools, and operational excellence will be central to your responsibilities. You will establish and manage governance rhythms including KPIs, performance reviews, risk management protocols, and quality oversight mechanisms. Serving as the senior escalation point for complex regulatory, delivery, and stakeholder challenges will require calm and decisive judgment. You will develop leadership capabilities through coaching, performance management, and structured succession planning initiatives. Collaboration with Finance, People, and Operations will ensure alignment on budgeting, workforce planning, and strategic scale-up decisions.
Key facts
What you'll do
- Oversee the end-to-end operating model for EAP Program and Site Management to ensure scalable and compliant delivery.
- Convert strategy and portfolio forecasts into capacity plans, organizational design, and hiring priorities.
- Develop resilient coverage and escalation models across the portfolio to eliminate single points of failure.
- Lead the EAP Program Management team to ensure consistent execution across clients and geographies.
- Lead the EAP Site Management team to strengthen site engagement, balance workloads, and maintain service performance.
- Drive standardization and continuous improvement in workflows, tools, and operational excellence.
- Establish and manage governance rhythms including KPIs, performance reviews, risk management, and quality oversight.
- Serve as the senior escalation point for complex regulatory, delivery, and stakeholder challenges.
- Develop leadership capabilities through coaching, performance management, and succession planning.
- Collaborate with Finance, People, and Operations on budgeting, workforce planning, and scale-up decisions.
- Ensure time zone coverage within EST or CST for North American-based applicants to facilitate seamless collaboration.
- Navigate market access and multi-country reimbursement strategies to support program feasibility.
- Uphold a high standard of quality while remaining composed under demanding operational conditions.
Requirements
- Possess 8-10 or more years of experience leading Expanded Access Programs with consistent results.
- Demonstrate ease in navigating market access and multi-country reimbursement strategies.
- Show a clear understanding of the EAP business with a proven commercial and client service focus.
- Have a record of building and leading high-performance teams under pressure.
- Exhibit the ability to lead managers and scale operations across multiple countries and time zones.
- Maintain a strong grasp of compliance and regulatory frameworks for Expanded Access Programs.
- Deliver a track record of operational excellence in scaling delivery and elevating performance standards.
- Think strategically with a focus on execution, simplifying complexity, and achieving clear outcomes.
- Manage senior stakeholders and align external partners with confidence.
- Uphold a high standard of quality while remaining composed under pressure.
- Be located in The Netherlands, United Kingdom, Canada, or USA.
- Applicants in North America must reside within the Eastern or Central Standard Time zones.
- Commit to the role may include occasional travel as required by operational needs.
Nice to have
- Experience in healthcare or life sciences settings where access is critical.
Practical notes
The role may include occasional travel. Time zone coverage within EST or CST is required for North American-based applicants.