Global Patient Access Operations Lead

Job Description

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, 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

ACCOUNTABILITIES

• 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

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS

Required

• 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

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.

Compensation and Benefits Summary

• U.S. Base Salary Range: $ – $
• U.S. employees may be eligible for short-term and long-term incentives, medical, dental, vision, 401(k) plan with company match, disability coverage, life insurance, tuition reimbursement, paid volunteer time off, company holidays, well-being benefits, up to 80 hours of sick time, and up to 120 hours of paid vacation.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.