Head of Device Development (Vice President)

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Job Description

Objectives/Purpose:

• Leads the global Device Development organization and end-to-end delivery of device and combination product engineering from early feasibility through Design Controls tech transfer launch and sustaining engineering.

• Owns the enterprise device/combination product strategy across modalities ensuring fit-for-purpose platforms and capabilities aligned to pipeline needs.

• Partners with other PharmSci functions Drug Product departments and key external stakeholders (GSQ Quality Regulatory CMC Clinical Commercial) to deliver compliant scalable patient-centered delivery solutions.

Accountabilities:

• Owns and executes the global device and combination product (drug-device) development strategy across the portfolio aligned to TAU and pipeline needs from early feasibility through lifecycle management.

• Leads end-to-end device engineering and Design Controls execution (user needs design inputs/outputs risk management verification/validation DHF/DMR/tech file readiness) for both internal and partner-developed systems.

• Accountable for robust phase-appropriate device/combination product CMC strategies including human factors/usability engineering reliability engineering and design-for-manufacture/assembly/serviceability.

• Ensures compliant global regulatory delivery of device/combination product content within IND/CTA/MAA/NDA/BLA submissions as applicable including effective health authority engagement and right-first-time responses.

• Leads device industrialization and tech transfer to manufacturing and suppliers including process validation strategy (as applicable) supplier qualification and scalable manufacturing controls for commercial readiness.

• Establishes and governs a platform-device and primary container/closure strategy (where relevant) to improve speed cost and reuse across programs while maintaining patient safety quality and performance.

• Owns post-launch sustaining engineering strategy and execution (complaints investigations CAPA change control obsolescence supplier changes field actions/recalls support) in partnership with Quality/GSQ.

• Drives external innovation and partnerships (device suppliers CDMOs/CMOs design houses digital/connected device partners) including build/buy/partner decisions and IP strategy support.

• Champions digital engineering capabilities (model-based design simulation tolerance analysis reliability modeling and data-driven failure analysis) to reduce iteration cycles and improve predictability.

• Builds develops and leads a high-performing global organization; sets clear operating mechanisms talent strategy and resource allocation across programs and geographies.

Core Elements Related to this Role:

Dimensions and Aspects:

Technical/Functional (Line) Expertise:

• Deep expertise in drug delivery device development and combination products spanning early concept/feasibility through Design Controls industrialization launch and sustaining engineering.

• Demonstrated experience with global device and combination product regulatory expectations and standards (e.g. FDA device/combination product requirements EU MDR/IVDR where relevant ISO 13485 ISO 14971 IEC 62366 relevant USP/ISO standards for delivery systems/containers).

• Strong technical depth in human factors engineering/usability risk management reliability engineering materials selection and design-for-manufacture/assembly.

• Proven experience leading supplier ecosystems and outsourced development/manufacture: supplier qualification quality agreements audits change management and performance governance.

• Track record of successful approvals and commercialization for device and/or combination products including robust documentation (DHF/technical files) and cross-functional launch execution.

• Understanding of interface points to drug product development (e.g. container closure systems extractables/leachables strategy alignment compatibility delivery performance and clinical use considerations).

Leadership:

• Strategic thinking facilitative leadership.

• Executive leadership presence and confidence.

• Enterprise level leadership with the ability to inspire motivate and drive results.

• Excellent communicator able to persuasively convey both ideas and data verbally and in writing.

• Ability to assemble and manage a diverse and high performing team.

• Demonstrated ability to lead teams across functions regions and cultures.

• Ability to distill complex issues and ideas down to simple comprehensibility.

• Proven skills as leader who can engender credibility and confidence within and outside the company.

• 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 highly complex decisions that impact the enterprise.

• Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions.

• Ability to incorporate feedback and ensure decisions are made transparently and swiftly to yield flawless execution.

• Accountable for designing and implementing vision and strategy for designated scope.

Interaction:

• Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring an engaging and inclusive workplace.

• Ability to effectively implement R&Ds partnership strategy.

• Effectively represent Takeda in high-level negotiations with the ability to resolve conflict in a constructive manner.

• Ability to build strong partnerships and drive role clarity with other interfacing Takeda functions including but not limited to Pharmaceutical Sciences GSQ GPLS and Regulatory CMC.

Innovation:

• Visionary and forward thinking with the ability to influence and effectively drive organizational change and continuous innovation.

• Comfortable challenging the status quo and bringing forward innovative solutions.

• Ability to take risks implementing innovative solutions accelerating time to market.

Education Behavioral Competencies and Skills:

• Bachelors degree in chemistry biology pharmacy engineering or related pharmaceutical science and 25 years relevant industry experience.

• Masters degree in chemistry biology pharmacy engineering or related pharmaceutical science; 20 years relevant industry experience.

• PhD in chemistry biology pharmacy engineering or related pharmaceutical science; 15 years relevant industry experience.

• Extensive relevant industry experience in device and/or combination product development including global leadership and commercialization support.

• Demonstrated people and program management skills critical and out-of-the-box thinking ability.

• Demonstrated ability to anticipate issues and manage a team to proactively implement solutions.

• Experience in assuring the implementation of required quality processes and standards to facilitate smooth transition from product development to commercialization.

• Demonstrated expertise in writing regulatory documents.

• Understands the structure functions and methods of the global Takeda organization and overall Takeda R&D and Commercial operations.

• Excellent organizational and communication skills. Has the ability to influence at all levels of the organization and manage projects and initiatives across businesses and the globe.

• Demonstrated ability to negotiate difficult issues and arrive at mutually beneficial solutions.

• Ability to analyze a wide variety of information and data to make management decisions regarding potential risks associated with product quality and regulatory compliance.

• Demonstrated ability to effectively lead and motivate a team of direct reports build on strengths and address areas for improvement.

• Proven record of building mutually-respectful relationships across global regions and companies in order to foster communication and achieve strategic goals.

This position is currently classified as hybrid in accordance with Takedas Hybrid and Remote Work policy.

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 companys discretion.

• It is possible the department and workplace may change at the companys discretion.

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