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.
