Global Patient Access Operations Lead

About the role

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, enabling consistent execution across geographies.

Leverage technology, data, and analytics to enhance program execution, tracking, and performance visibility, supporting data-driven decision-making.

Utilize systems, data, and reporting insights to support execution, monitoring, and continuous improvement.

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.
• 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.

Qualifications

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

Skills

• Strong leadership and project management skills.
• Excellent communication and collaboration abilities.
• Proficiency in data analysis and reporting tools.
• Knowledge of regulatory requirements and compliance standards.
• Ability to work independently and as part of a team.

Additional Information

Percentage of travel: Requires approximately 10% travel, including overnight and international travel to other Takeda sites and meetings with external partners.

Base Salary Range: CHF148,600.00 - CHF204,270.00

If you are interested in this opportunity, we look forward to receiving your application via our online tool!

Learn more at takedajobs.com

Locations: Zurich, Switzerland | USA - MA - Cambridge