Device Development Lead, Associate Director

Takeda•Lexington, MA

3d•$154,400 - $242,550•Onsite

About The Position

The Device Development Lead (DDL) will be accountable for device program execution, ensuring the translation of product development strategy into clear and actionable plans and deliverables. The DDL will work closely with Device Program Teams (DPTs) and the drug Global Program Teams (GPTs) as required to ensure alignment of the device strategy and execution. The DDL will also work with the Device Project Managers (DPM) to ensure proper planning and execution of the project plan. This role involves leading a cross-functional team or multiple teams for devices through clinical development, product registration, and commercialization. Projects may also include Life Cycle Management (LCM) products that require further development. The DDL will have overall accountability for the creation, management, and execution of device development project plans by building consensus within the cross-functional teams, driving and managing the budgeting process for specific device development plans, and monitoring and managing overall program risk, providing risk mitigation solutions. The DDL will report project status to DPT/GPT and/or PDT leadership committees on a regular basis, promoting visibility and transparency of information within the device development team and across cross-functional groups, and ensuring device development activities align with Takeda’s Stage Gate Milestone framework and support Design Transfer readiness.

Requirements

BS/BEng in relevant engineering or scientific area of study with minimum twelve (12+) years of relevant experience.
Relevant experience is in device development and commercialization with demonstrated success leading cross functional, global or enterprise-wide programs in the biotech/pharmaceutical or medical device industry.
Relevant experience is in device development and commercialization with demonstrated success leading multi-site, global or enterprise-wide programs in the medical device or biotech/pharmaceutical industry.
In particular, end-to-end development experience with capital equipment is required.
Proven Leader with ability to manage multiple complex cross-functional teams and processes to deliver key accountabilities.
Demonstrated experience managing programs in different stages of development in many therapeutic areas.
Strong knowledge and understanding of global device product development and commercialization in the pharmaceutical industry is preferred.
Strong understanding of the relevant regulatory frameworks that govern devices across the product lifecycle.
Strong understanding of the business environment and relevant key strategic, operational drivers and competitive environment.
Excellent knowledge and application of elements of device-related product development and the 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.
Able to translate strategies into tangible deliverables for team to execute, and able to manage and resolve complex strategic and operational issues and interactions between programs.
Lead device program teams by building consensus within the team and DPTs/GPTs.
Independent and creative thinker requiring minimum oversight. A self-starter who is pro-active, motivates, and has tact, diplomacy, true team player, and leadership skills.
Well versed with 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.

Responsibilities

Lead and drive development and execution of Target Device Profile (TDP) and drug Target Product Profile (TPP) alignment.
Overall responsibility for the 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 the cross-functional teams.
Drive budgeting process and ensure adequate resource deployment (OPEX/spend, CAPEX and FTE) in support of the approved integrated device development plan.
Monitor the overall program risk and communicate as appropriate.
Represent Device development team at Takeda’s product governance bodies incl. GPT, PDT (Plasma Derived Therapies business unit) among others.
Facilitate preparations and analyses related to device relevant business reviews, scenario planning and routine evaluation processes, and progress against strategy and action plans.
As appropriate, 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 in alignment 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.
As need, support digital health initiatives by integrating connected care capabilities into device development plans.
Oversee quality assurance activities and ensure compliance with internal SOPs and external regulatory standards.
Manage multiple program teams as needed 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 but not limited to; 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 plan, ensuring alignment to program strategy.