Global Patient Access Operations Lead
2 days ago
We are seeking a highly skilled Global Patient Access Operations Lead to join our team at Takeda Pharmaceutical Company Ltd. As a key member of our Patient Access organization, you will be responsible for operational leadership to ensure successful execution of Patient Access programs from planning to close-out.
Key Responsibilities- 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 with 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.
- 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.
- Advanced degree in a Health science field preferred (e.g., Nursing, Pharmacy, Public Health).
This is a full-time position that requires approximately 10% travel, including overnight and international travel to other Takeda sites and meetings with external partners.
We offer a competitive compensation package, including a U.S. base salary range of $133,000.00 to $209,000.00, and eligibility for short-term and/or long-term incentives, medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits.
Takeda is an equal opportunity employer and welcomes applications from diverse candidates.
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