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At our heart we are committed colleagues. We offer interested people numerous opportunities and strongly believe in, and promote, diversity, equity, and inclusion. As a company we offer roles based on merit, welcoming candidates of any gender, age, religious belief, sexual orientation, race, color, ethnic or social origin, or disability.
Our team is growing and for this we need bright minds with creativity and flexibility – what talent do you have?
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
How you will contribute:
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
Skills and qualifications:
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.
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. We incorporate these values in everything we do. They represent who we are and how we act. They help us make decisions that we can be proud of today and in the future. We enable our employees to develop their full potential. As a global top employer, we offer exciting career paths, promote innovation, and strive for top performance in everything we do. 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.
If you are interested in this opportunity, we look forward to receiving your application via our online tool!
Learn more at takedajobs.com
Zurich, SwitzerlandUSA - MA - Cambridge
Base Salary Range:
CHF148,600.00 - CHF204,270.00
For information about our benefits, please click here
Employee
Regular
Full time
We strive to transform lives. While the science we advance is constantly evolving, our core purpose is enduring. For more than two centuries, our values have guided us to do what’s right for patients and for society.
We know that changing lives requires us to do things differently. We start by listening to and addressing what really matters to patients, the people who love them, and those in the healthcare system who provide care. And that’s what inspires us all to be bold, push boundaries and set new standards that open up greater opportunities.
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