Global Patient Access Operations Lead

Takeda•Cambridge, MA

1d•$178,100 - $244,860•Onsite

About The Position

This role is responsible for leading the operational delivery of Pre-Approval Access programs, ensuring effective execution from planning through close-out. The Lead will translate strategy into structured operational plans, processes, and tools, enabling consistent execution across geographies. They will leverage technology, data, and analytics to enhance program execution, tracking, and performance visibility, supporting data-driven decision-making. The role also involves utilizing systems, data, and reporting insights to support execution, monitoring, and continuous improvement.

Requirements

PhD, PharmD with ~3+years; MS with ~6+ years; BS with ~8+ years experience or related experience in clinical research or expanded access in the pharmaceutical industry or CRO.
Experience operationalizing and coordinating Expanded Access/Compassionate use programs and initiatives.

Nice To Haves

Advanced degree in a Health science field preferred (e.g. Nursing, Pharmacy, Public Health).

Responsibilities

Lead end-to-end operational execution of Pre-Approval Access programs, from program setup through launch, delivery, and close-out, ensuring timely and compliant execution.
Develop and manage detailed operational plans, workflows, and documentation, including end-to-end process flows from triage through drug delivery.
Drive standardized execution of GPA programs, ensuring consistent application of processes, tools, and templates across regions and program types.
Oversee program operations within digital platforms (e.g., One Patient Access) to manage workflows, track milestones, and ensure execution visibility.
Ensure accurate data capture, tracking, and reporting across programs, supporting operational monitoring and regulatory deliverables (e.g., PSUR, PSMF).
Partner with systems and analytics teams to maintain and enhance operational tools, dashboards, and reporting processes supporting execution efficiency.
Coordinate cross-functional execution across Medical, Clinical, Regulatory, Supply, and external partners to ensure seamless and timely program delivery.
Manage program budgets, forecasting, and supply coordination, in partnership with Finance and Supply Chain, to support delivery requirements.
Ensure compliance with regulatory requirements, internal policies, and SOPs, maintaining audit and inspection readiness across all program activities.
Support continuous improvement of operational processes, identifying execution gaps and implementing enhancements to improve efficiency, quality, and scalability.