Head of Device Development (Vice President)
Takeda
5 hours ago
Remote friendly (Boston, MA)
United States
$259,000 - $407,000 USD yearly
Operations
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 PharmSci functions, Drug Product departments and 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 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 internal and partner-developed systems.
- Owns robust, phase-appropriate device/combination product CMC strategies (human factors/usability, reliability engineering, design-for-manufacture/assembly/serviceability).
- Ensures compliant global regulatory delivery within IND/CTA/MAA/NDA/BLA submissions as applicable, including health authority engagement and right-first-time responses.
- Leads device industrialization and tech transfer to manufacturing and suppliers (process validation strategy as applicable, supplier qualification, scalable manufacturing controls).
- Establishes and governs platform-device and primary container/closure strategy (where relevant) to improve speed, cost, and reuse while maintaining safety, quality, and performance.
- Owns post-launch sustaining engineering (complaints, investigations, CAPA, change control, obsolescence, supplier changes, field actions/recalls support) with Quality/GSQ.
- Drives external innovation and partnerships (device suppliers, CDMOs/CMOs, design houses, digital/connected devices), including build/buy/partner decisions and IP strategy support.
- Champions digital engineering capabilities (model-based design, simulation, tolerance analysis, reliability modeling, data-driven failure analysis).
- Builds and leads a high-performing global organization; sets operating mechanisms, talent strategy, and resource allocation.
Technical/Functional Expertise:
- Deep expertise in drug delivery device development and combination products through Design Controls, industrialization, launch, and sustaining.
- Experience with global device/combination product regulatory expectations and standards (FDA; EU MDR/IVDR where relevant; ISO 13485, ISO 14971, IEC 62366; relevant USP/ISO standards).
- Strong technical depth in human factors/usability, risk management, reliability engineering, materials selection, and design-for-manufacture/assembly.
- Proven experience leading supplier ecosystems and outsourced development/manufacture qualification (quality agreements, audits, change management, performance governance).
- Track record of approvals and commercialization with robust documentation (DHF/technical files) and cross-functional launch execution.
- Understanding of drug product interface points (container closure systems, extractables/leachables alignment, compatibility, delivery performance, clinical use considerations).
Leadership/Decision-Making/Interaction:
- Strategic, facilitative executive leadership; ability to lead diverse global teams and communicate persuasively.
- Ability to make highly complex enterprise-impacting decisions; seek diverse stakeholder input.
- Ability to represent the company in high-level negotiations and build partnerships across functions.
Innovation:
- Drives continuous innovation; challenges status quo; comfortable taking risks to accelerate time to market.
Education/Qualifications:
- Bachelor’s degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science + 25+ years relevant industry experience; or
- Master’s degree + 20+ years relevant industry experience; or
- PhD + 15+ years relevant industry experience.
Required/Preferred Skills (from description):
- Extensive device and/or combination product development experience with global leadership and commercialization support.
- People/program management skills; ability to anticipate issues and proactively implement solutions.
- Experience ensuring quality process implementation for transition to commercialization.
- Demonstrated expertise writing regulatory documents.
- Strong organizational and communication skills; ability to influence at all levels and manage global initiatives.
- Ability to negotiate difficult issues and analyze information/data to assess quality and regulatory risk.
Benefits (explicitly stated):
- Eligible for short-term and/or long-term incentives.
- Eligible for medical, dental, vision insurance; 401(k) plan and company match; short-term and long-term disability; basic life insurance; tuition reimbursement; paid volunteer time off; company holidays; well-being benefits; up to 80 hours sick time/year; and up to 120 hours paid vacation for new hires.
Application Instructions:
- Apply via the “Apply” button; submitting an application will commence the employment application process and your information will be processed per Takeda’s Privacy Notice and Terms of Use.
- 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 PharmSci functions, Drug Product departments and 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 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 internal and partner-developed systems.
- Owns robust, phase-appropriate device/combination product CMC strategies (human factors/usability, reliability engineering, design-for-manufacture/assembly/serviceability).
- Ensures compliant global regulatory delivery within IND/CTA/MAA/NDA/BLA submissions as applicable, including health authority engagement and right-first-time responses.
- Leads device industrialization and tech transfer to manufacturing and suppliers (process validation strategy as applicable, supplier qualification, scalable manufacturing controls).
- Establishes and governs platform-device and primary container/closure strategy (where relevant) to improve speed, cost, and reuse while maintaining safety, quality, and performance.
- Owns post-launch sustaining engineering (complaints, investigations, CAPA, change control, obsolescence, supplier changes, field actions/recalls support) with Quality/GSQ.
- Drives external innovation and partnerships (device suppliers, CDMOs/CMOs, design houses, digital/connected devices), including build/buy/partner decisions and IP strategy support.
- Champions digital engineering capabilities (model-based design, simulation, tolerance analysis, reliability modeling, data-driven failure analysis).
- Builds and leads a high-performing global organization; sets operating mechanisms, talent strategy, and resource allocation.
Technical/Functional Expertise:
- Deep expertise in drug delivery device development and combination products through Design Controls, industrialization, launch, and sustaining.
- Experience with global device/combination product regulatory expectations and standards (FDA; EU MDR/IVDR where relevant; ISO 13485, ISO 14971, IEC 62366; relevant USP/ISO standards).
- Strong technical depth in human factors/usability, risk management, reliability engineering, materials selection, and design-for-manufacture/assembly.
- Proven experience leading supplier ecosystems and outsourced development/manufacture qualification (quality agreements, audits, change management, performance governance).
- Track record of approvals and commercialization with robust documentation (DHF/technical files) and cross-functional launch execution.
- Understanding of drug product interface points (container closure systems, extractables/leachables alignment, compatibility, delivery performance, clinical use considerations).
Leadership/Decision-Making/Interaction:
- Strategic, facilitative executive leadership; ability to lead diverse global teams and communicate persuasively.
- Ability to make highly complex enterprise-impacting decisions; seek diverse stakeholder input.
- Ability to represent the company in high-level negotiations and build partnerships across functions.
Innovation:
- Drives continuous innovation; challenges status quo; comfortable taking risks to accelerate time to market.
Education/Qualifications:
- Bachelor’s degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science + 25+ years relevant industry experience; or
- Master’s degree + 20+ years relevant industry experience; or
- PhD + 15+ years relevant industry experience.
Required/Preferred Skills (from description):
- Extensive device and/or combination product development experience with global leadership and commercialization support.
- People/program management skills; ability to anticipate issues and proactively implement solutions.
- Experience ensuring quality process implementation for transition to commercialization.
- Demonstrated expertise writing regulatory documents.
- Strong organizational and communication skills; ability to influence at all levels and manage global initiatives.
- Ability to negotiate difficult issues and analyze information/data to assess quality and regulatory risk.
Benefits (explicitly stated):
- Eligible for short-term and/or long-term incentives.
- Eligible for medical, dental, vision insurance; 401(k) plan and company match; short-term and long-term disability; basic life insurance; tuition reimbursement; paid volunteer time off; company holidays; well-being benefits; up to 80 hours sick time/year; and up to 120 hours paid vacation for new hires.
Application Instructions:
- Apply via the “Apply” button; submitting an application will commence the employment application process and your information will be processed per Takeda’s Privacy Notice and Terms of Use.