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.
• Avoid inaccurate 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-functionally coordinate 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.

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

Preferred

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

Additional Information

• Percentage of travel: Requires approximately 10% travel, including overnight and international travel to other Takeda sites and meetings with external partners.
• Empowering our people to shine At Takeda, we earn the trust of society and our customers through our values of Takeda-ism: Integrity, Fairness, Honesty, Perseverance.
• Takeda fosters an inclusive, collaborative, and international work environment where our teams are united by their relentless commitment to our goal of improving people's health and creating a better future for the world.
• Diversity, Equality, and Inclusion Takeda is committed to foster diversity, equality, and inclusion. Hiring decisions are based entirely on qualifications and are made regardless of gender, ethnic origin, religion, sexual orientation, age, or disability.