Global Patient Access Operations Lead (Manager)

- Responsible for operational leadership to ensure successful execution of Patient Access programs from planning to close-out - Set-up and manage the operational activities of Patient Access programs - Develop and implement training and communication plans to build awareness, engagement and support for patient access programs and initiatives across the organization

- Lead operational activities to set-up and execute expanded access programs in collaboration with the GPA strategy lead. - Responsible for finalizing program documents , developing the end to end process flow (from triage to drug delivery) - Responsible for training and communications, program launch, program management and transition and program close-out activities - Provide expertise and operational guidance related to expanded access programs to cross-functional teams - Collaborates closely with cross-functional, global and local teams (e.g.

Medical affairs, Clinical supplies R&D) to deliver expanded access programs - Provide operational oversight of budget and drug supply forecasting for Patient Access programs in collaboration with other relevant internal stakeholders (e.g. Finance, Supply Chain).

- Responsible for ensuring accurate tracking, reporting, and metrics of Patient access programs (e.g PSUR, PSMF) in collaboration GPA Systems Lead - Manage relationships with key external partners and vendors - Maintains awareness of worldwide Regulatory guidance support implementation of best practices related to Patient Access across Takeda - Collaborates closely with other Patient Access teams (e.g.

Oncology) and provides operational support for other Patient Access mechanisms and initiatives as needed - Supports audits and inspections related to Patient Access - Participate in other activities, teams and committees as assigned

- Experience operationalizing and coordinating Expanded Access/Compassionate use programs and initiatives - Thorough knowledge of global regulatory requirements and guidance related to Patient Access

- Ability to improvise and demonstrate creativity in solving problems and achieving objectives - Comfortable with ambiguity and has the ability to work independently, take initiative and complete tasks in a timely manner - Ability to build strong relationships and collaborate effectively with other interfacing Takeda functions (e.g.

Medical affairs, Global manufacturing services, Ethics and Compliance) - Strong proven ability to collaborate cross-functionally and build consensus - Excellent written, oral communication and presentation skills - Must be able to work in a fast-paced environment with demonstrated ability to simultaneously manage multiple competing tasks and demands - Experience in Project Management - Experience working with supply chain, vendors, and external organizations (including corporations, associations, non-governmental organizations, and academic institutions) relevant to the patient access and global healthcare - Ability to access global information to define global operating strategies - Experience working within a complex, global organization and demonstrated ability to work across functions and regions without direct authority - Strong proven ability to collaborate cross-functionally and build consensus - Experience contributing to cross-functional initiatives - Ability to influence and work effectively with various disciplines and functional areas - Good working knowledge of MS Word, Excel, PowerPoint and Outlook.

- MS with 3+ years or BS with 5+ years experience or related experience in clinical research or expanded access in the pharmaceutical industry or CRO

- Advanced degree in a Health science field preferred (e.g. Nursing, Pharmacy, Public Health). - Previous experience operationalizing expanded access programs preferred

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

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.

The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.