Device Development Lead, Associate Director

About the role

The Device Development Lead (DDL) will be accountable for device program execution, translating product development strategy into clear and actionable plans and deliverables. The DDL will collaborate closely with Device Program Teams (DPTs) and Global Program Teams (GPTs) to ensure alignment of device strategy and execution, and will work with Device Project Managers (DPMs) to ensure proper planning and execution of project plans. The role involves leading cross-functional teams through clinical development, product registration, and commercialization, including Life Cycle Management (LCM) products. The DDL will oversee the creation, management, and execution of device development project plans, drive budgeting processes, monitor program risks, and provide risk mitigation solutions. Regular reporting on project status to DPT/GPT and/or PDT leadership committees is required, along with promoting visibility and transparency across cross-functional teams. The role ensures alignment with Takeda’s Stage Gate Milestone framework and supports Design Transfer readiness.

Responsibilities

• Lead and drive development and execution of Target Device Profile (TDP) and drug Target Product Profile (TPP) alignment.
• Overall responsibility for device program planning and execution.
• Develop and lead high-performing device development cross-functional teams.
• Create, manage, and ensure execution of integrated device development project plans by building consensus within cross-functional teams.
• Drive budgeting processes and ensure adequate resource deployment (OPEX/spend, CAPEX, and FTE) in support of the approved integrated device development plan.
• Monitor overall program risk and communicate as appropriate.
• Represent the device development team at Takeda’s product governance bodies, including GPT and PDT (Plasma Derived Therapies business unit).
• Facilitate preparations and analyses related to device-relevant business reviews, scenario planning, routine evaluation processes, and progress against strategy and action plans.
• Collaborate and communicate with GPTs and other cross-functional governance bodies to evaluate device-related product/program opportunities and develop integrated execution plans based on strategic objectives.
• Provide clear direction on device program requirements aligned with the Product/Device operating model to meet expectations of external customers and business stakeholders.
• Collaborate with global commercial teams to align device strategy with market needs and launch readiness.
• Support digital health initiatives by integrating connected care capabilities into device development plans as needed.
• Oversee quality assurance activities and ensure compliance with internal SOPs and external regulatory standards.
• Manage multiple program teams with a high-level view of program impact on GPT, DPT, and organizational strategy.
• Build and maintain strong relationships with key internal and external partner organizations, including contract R&D and manufacturing organizations, device OEM suppliers, Global Product Leads, Clinical Science, Clinical Operations, Quality Assurance, Procurement, Business Development, Research, and brand teams.
• Facilitate execution of the global device program strategy.
• Lead and drive development and execution of strategic device plans, Long Range Plan, Life Cycle Management (LCM) Plan, and geographic expansion plans, ensuring alignment to program strategy.

Requirements

• BS/BEng in a relevant engineering or scientific field with a minimum of twelve (12+) years of relevant experience.
• Relevant experience in device development and commercialization with demonstrated success leading cross-functional, global, or enterprise-wide programs in the biotech/pharmaceutical or medical device industry.
• End-to-end development experience with medical devices, including capital equipment, is required.
• Proven leadership ability to manage multiple complex cross-functional teams and processes to deliver key accountabilities.
• Demonstrated experience managing programs at different stages of development across multiple therapeutic areas.
• Strong knowledge and understanding of global device product development and commercialization in the pharmaceutical industry.
• Strong understanding of relevant regulatory frameworks governing devices across the product lifecycle.
• Strong understanding of the business environment, key strategic and operational drivers, and competitive landscape.
• Excellent knowledge of device-related product development elements and relevant quality management systems.
• Excellent knowledge and execution of subcontractor management and CMOs.
• Strong understanding and competency in planning processes and decision-making.
• Demonstrated experience using standard program management tools and software, including integrated development plans, timelines, risk management, and budget development and monitoring.

Key Skills, Abilities, and Competencies

• Able to translate strategies into tangible deliverables for the team to execute and manage complex strategic and operational issues and interactions between programs.
• Lead device program teams by building consensus within the team and with DPTs/GPTs.
• Independent and creative thinker requiring minimal oversight; proactive self-starter with strong motivation, tact, diplomacy, and leadership skills.
• Well-versed in the medical device product development process and FDA/EU MDR guidelines.
• Familiar with Microsoft Project; demonstrated versatility in operations/program management tools to facilitate functional and geographic collaboration and maximize team effectiveness.

Pay

Base Salary Range (Lexington, MA, U.S.): $154,400.00 – $242,550.00. The actual base salary offered may vary based on qualifications, experience, skills, education, certifications, location, and other factors. The salary will comply with applicable state or local minimum wage requirements.