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.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:
USA - MA - Cambridge - Kendall Square - 500

U.S. Base Salary Range:
$178,100.00 - $244,860.00

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.

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in 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, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

Locations
USA - MA - Cambridge - Kendall Square - 500

Worker Type
Employee

Worker Sub-Type
Regular

Time Type
Full time

Job Exempt
Yes