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Job Description

OBJECTIVES/PURPOSE

• Direct and drive the implementation of regional compliance management related to quality events and internal audits for clinical trial delivery functions including the identification and development of applicable processes and tools
• Establish and lead proactive risk-based compliance assessments for regional clinical trial activities and ensure completion of robust CAPA/EC-related compliance assessments
• Develop and report to leadership on key performance indicators and mitigation strategies for regional clinical trial delivery activities
• Provide regional expertise for program and study level GCP inspection readiness and inspection preparation strategies including process adherence, inspection-risk management, TMF oversight and proactive study team preparedness for audits and inspections

ACCOUNTABILITIES

Compliance Management

• Oversee and manage regional quality events/deviations including root cause analysis, CAPA development and implementation, effectiveness check tracking, and non-compliance reporting
• Facilitate regional and/or participate in Global clinical trial delivery internal audits with study teams and functional areas including but not limited to: study team preparation, facilitating audit requests, managing audit responses and CAPA development and implementation. Partner with Quality Assurance to ensure appropriate audit scopes and clinical trial delivery participation.
• Lead regional activities for clinical trial functional areas and study teams on issues related to GCP compliance and liaise with study execution teams on compliance to clinical trial delivery procedures and developing effective mitigation and escalation strategies
• Participate in GCP Excellence in Clinical Trials strategies to incorporate regional considerations to enable clinical trial functional areas and study teams to embed inspection readiness and process adherence into ways of working. 
• Participate as a regional expert in Global activities with R&D Quality and GCP Compliance Management to develop GCP inspection strategy in support of submission planning and routine inspections
• Partner with Quality Assurance to ensure appropriate audit scopes and clinical trial delivery participation for regional activities; providing regular status updates to appropriate stakeholders and leadership
• Serve as an expert in TMF process and participate in strategy and implementation of risk-based TMF oversight strategies for study execution teams to incorporate regional considerations. 
• May serve as inspectorate facing TMF subject matter expert for regulatory inspections of Takeda

Compliance Assessments

• Proactively identify process/therapeutic area/project risks and develop/lead assessments to assess compliance
• Advise process owners and functional areas on the development and implementation of effective mitigation and escalation strategies for projects including regional considerations to address risks and issues
• Develop, lead and oversee regional and/or global compliance assessments to address GCP Quality Plan, CAPAs/ECs and liaise with QA to ensure adherence to the plan

GCP Compliance Metrics and Reporting

• Engage and build relationships with clinical trial delivery functions, R&D QA, and other stakeholders on performance metrics, analytics and reporting for GCP compliance activities
• Identify, develop, and track KPIs, metrics and dashboards to track process quality and compliance

Other

• Responsible for training, coaching and mentoring supervised employees (direct and indirect reports) to create a culture that attracts, retains and develops innovative thinkers
• Act as role model for Takeda's values

CORE ELEMENTS RELATED TO THIS ROLE

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

• Thorough knowledge of pharmaceutical industry and deep understanding of drug development from research through commercialization
• Strong understanding of global and local regulations within the region
• Experience in leading global teams
• Sufficient knowledge of communication tools including online meeting and virtual meeting platforms to optimize communication and information exchange in a global environment

Leadership

• Demonstrated ability to work across functions, regions and cultures
• Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing
• Proven skills as an effective team player who can engender credibility and confidence within and outside the company
• Ability to distill complex issues and ideas down to simple comprehensible terms
• Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization

Decision-making and Autonomy

• Broad decision making responsibilities:
  • Ability to make complex decisions
  • Ability to develop solutions to complex issues and challenges
  • Accountable for decision making for designated function
  • Ability to incorporate feedback and ensure decisions are made swiftly

Interaction

• Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace
• Ability to build strong partnerships and drive role clarity with other interfacing Takeda functions

Innovation

• Comfortable challenging the status quo and bringing forward innovative solutions

Complexity

• Ability to work in a global ecosystem (internal and external) with a high degree of complexity
• Breadth of knowledge required across therapeutic areas, indications, and/or modalities

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: 

• Bachelor's Degree or international equivalent required; Life Sciences preferred
• 8+ years' experience in the pharmaceutical industry and/or clinical research organization, including 6+ years in compliance or clinical study management
• Experience in leading projects and coordinating collaboration with cross-functional teams
• Strong strategic thinking, planning, execution, and communication skills
• Global/international experience required, including ability to collaborate with colleagues and staff in other locations
• Operational experience in clinical development with significant direct exposure to implementation of novel approaches in clinical development
• Health care business acumen with a comprehensive understanding of the pharmaceutical industry

Takeda Compensation and Benefits Summary:

• Allowances: Commutation, Housing, Overtime Work etc.

• Salary Increase: Annually, Bonus Payment: Twice a year

• Working Hours: Headquarters (Osaka/ Tokyo) 9:00-17:30, Production Sites (Osaka/ Yamaguchi) 8:00-16:45, (Narita) 8:30-17:15, Research Site (Kanagawa) 9:00-17:45

• Holidays: Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year)

• Paid Leaves: Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave.

• Flexible Work Styles: Flextime, Telework

• Benefits: Social Insurance, Retirement and Corporate Pension, Employee Stock Ownership Program, etc.

Important Notice concerning working conditions:

• It is possible the job scope may change at the company's discretion.

• It is possible the department and workplace may change at the company's discretion.

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