Global Patient Access Operations Lead

Objectives/Purpose:
- Lead the operational delivery of Pre-Approval Access programs, ensuring effective execution from planning through close-out
- Translate strategy into structured operational plans, processes, and tools for consistent execution across geographies
- Use technology, data, and analytics to enhance program execution, tracking, and performance visibility
- Utilize systems, data, and reporting insights to support execution, monitoring, and continuous improvement

Accountabilities:
- Lead end-to-end operational execution of Pre-Approval Access programs (setup, launch, delivery, close-out) with timely and compliant execution
- Develop and manage operational plans, workflows, and documentation, including process flows from triage through drug delivery
- Drive standardized execution of GPA programs across regions and program types
- Oversee program operations within digital platforms (e.g., One Patient Access) to manage workflows and track milestones
- Ensure accurate data capture, tracking, and reporting (e.g., PSUR, PSMF)
- Partner with systems and analytics teams to maintain/improve operational tools, dashboards, and reporting
- Coordinate cross-functional execution (Medical, Clinical, Regulatory, Supply, external partners)
- Manage budgets, forecasting, and supply coordination with Finance and Supply Chain
- Ensure compliance with regulatory requirements, internal policies, and SOPs; maintain audit/inspection readiness
- Support continuous improvement of operational processes

Required:
- PhD/PharmD (~3+ years), MS (~6+ years), or BS (~8+ years) in clinical research or expanded access in pharma/CRO
- Experience operationalizing and coordinating Expanded Access/Compassionate use programs

Preferred:
- Advanced degree in a health science field (e.g., Nursing, Pharmacy, Public Health)

Additional Information:
- ~10% travel (overnight and international to other sites and meetings with external partners).