Director, Expanded Access Program Operations
Core
End-to-end operational delivery of Expanded Access Programs (EAPs) globally, integrating Program Management and Site Management to ensure scalable, compliant, and outcome-driven delivery for BioPharma clients and patients.
Role type
Senior leadership IC (Director of Operations)
Builds
Scalable EAP operational model and service delivery for drug development ecosystem stakeholders
Domain
Healthcare / Life Sciences / Drug Development / Expanded Access Programs
Required skills
EAP program management, site management, operational excellence, team leadership, commercial acumen, regulatory compliance, capacity planning, risk management, stakeholder management
Preferred skills
Market access experience, multi-country reimbursement strategies, scaling operational teams
Technologies
None explicitly stated
Responsibilities
Own end-to-end operating model for EAP Program and Site Management; Translate strategy into capacity planning and org design; Build resilient coverage and escalation models; Lead Program Management team for consistent execution; Lead Site Management team for strong engagement and performance; Drive standardization and continuous improvement; Set and run governance rhythm (KPIs, risk, quality); Act as senior escalation point for complex challenges; Build leadership bench through coaching and succession planning; Partner with Finance and People on budgeting and scale-up decisions
Seniority
Director, strategic leadership with hands-on operational oversight