Director, Device Development – Medical Device Center of Excellence Description at Takeda Pharmaceuticals


Director, Device Development – Medical Device Center of Excellence

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Job ID R0027346 Date posted 02/23/2021
Location Lexington, Massachusetts

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire and empower you to shine?  Join us as a Director, Device Development in our Medical Device Center of Excellence located at our Lexington, MA office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

As a Director, Device Development you will be empowered to be a key player in the Pharmaceutical Sciences division of Takeda and will lead the development of the product device strategy.

POSITION OBJECTIVES:

The Director, Device Development or Device Development Leader (DDL) position is a high impact leadership role responsible for leading the development of the product device strategy, including technology/platform choice, partner/vendor selection, clinical strategy, regulatory strategy, etc. The successful candidate will be a cross-functional leaders empowered to independently work with our Global Program Teams (GPT). 

The Director, Device Development or DDL role requires a talented leader with proven expertise in overseeing cross-functional, global team activities and is expected to be knowledgeable about the overall device development activities. As the leader of the device development sub team, the DDL is accountable for device program execution ensuring the translation of product strategy into clear and actionable plans/deliverables. The DDL will also work closely with the Global Program Leader (GPL)/Product Operations Leader (POL) on the GPT and GMSGQ PT as appropriate to ensure alignment of target device profile with target product profile and Takeda’s Device strategy.

The DDL communicates with all governance bodies and represent the device sub team at GPT and functional leadership teams.

POSITION ACCOUNTABILITIES:

Primary Responsibilities (70%)

  • The Director, Device Development or DDL facilitates elaboration, approval, and execution of the global device program strategy.

  • Lead and drive development and execution of Strategic Device Plans, Target Device Profile (TDP), TPP alignment, Long Range Plan, Life Cycle Management Plan, and Geographical Expansion Plan, ensuring alignment to program strategy.

  • Collaborate and communicate GPT and GMSGQ Product Team to ensure coordinated evaluation of product opportunities/scenarios and development of comprehensive, integrated recommendations (e.g., to Governance Committees) and strategic and operational product plans based on program defined objectives and priorities.

  • Represent Device development team at Takeda product governance bodies incl. GPT as well as GMSGQ, CMC, and other sub teams.

  • Drive program execution excellence.

  • Develop and lead high performing device development teams.

  • Ensure execution of integrated device development project plans build by GPM and global device sub-team (GDT).

  • Drive budgeting process and ensure adequate resource deployment ($ and FTE) in support of the approved integrated device development plan.

  • Facilitate preparations and analyses of device relevant business reviews and routine evaluation processes, and progress against strategy and action plans.

  • Promote visibility and transparency of information within the device development team, across program sub-teams and GPTs to accelerate decision making, obtain alignment, and increase foundational knowledge.

  • Escalate significant deviations from plans and budgets in a timely manner.

  • Ensure patient safety and compliance during program development and LCM.

  • Provide clear direction on product development requirements in alignment with the Product/Device operating model to meet expectations of external customers and business stakeholders.

  • Demonstrate strong finance and business acumen and oversight of the device program budget and long range plan.

Other Responsibilities (30%)

  • Establish and foster strong collaborative relationships with external industry partners and academia.

  • Contribute to Takeda’s device strategy.

  • Support device relevant BD activities as required.

  • Must build and maintain strong relationships with key internal and external partner organizations including but not limited to; Component Suppliers, Contract packagers, Product Strategy Leads, Quality Assurance, Procurement, Business Development, Research and the Brand Teams.

  • To remain current with developments in their respective specialization or practice by actively engaging in and participating in professional organizations.

  • Represents device development and external manufacturing on development and commercialization teams as appropriate by interfacing with Regulatory, Marketing, Product Strategy Leaders, Global Labeling Operations and other internal or external customers on new and existing products introductions.

  • Must be able to function independently and influence appropriate stakeholders and recommend scientifically rigorous, risk-management based solutions to complex technical challenges.

CORE ELEMENTS RELATED TO THIS ROLE:

  • Able to translate strategies into tangible deliverables for team to execute and to manage and resolve complex strategic and operational issues and interactions between programs.

  • 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.

  • Strong interpersonal skills including cultural awareness and sensitivities, negotiation, managing meetings and group dynamics, conflict resolution, ability to balance concerns of line management with objectives of cross-functional team.

  • Ability to influence people at all levels in the organization without authority and negotiate competing priorities.

  • Significant experience working with and/or leading cross-functional and global teams.

  • Polished communication and presentation skills, including executive level written and oral recommendations and communications; global and cross-functional communications.

  • Ability to provide insight into complex multi-functional interdependencies and assist in providing related budget and FTE impact.

  • Ability to mentor and influence new team on team membership requirements, responsibilities and deliverables.

  • Ability to identify key priorities, align strategic and tactical plans and motivate cross-functional teams and drive effective partnerships across functions.

  • Able to challenge product/ project assumptions in order to resolve conflicts, optimize schedule, costs and quality. Ensure alignment of asset goals and objectives.

  • In-depth knowledge and use of Microsoft Project; demonstrated versatility in operations / program management tools to facilitate functional and geographic collaboration and maximize team effectiveness.

DIMENSIONS AND ASPECTS:

Technical/Functional (Line) Expertise

  • Facilitate preparations and analyses of device relevant business reviews and routine evaluation processes, and progress against strategy and action plans.

  • Promote visibility and transparency of information within the device development team, across program sub-teams and GPTs to accelerate decision making, obtain alignment, and increase foundational knowledge.

  • Escalate significant deviations from plans and budgets in a timely manner.

Leadership

  • Lead and drive development and execution of Strategic Device Plans, Target Device Profile (TDP), TPP alignment, Long Range Plan, Life Cycle Management Plan, and Geographical Expansion Plan, ensuring alignment to program strategy.

  • Collaborate and communicate GPT and GMSGQ Product Team to ensure coordinated evaluation of product opportunities/scenarios and development of comprehensive, integrated recommendations (e.g., to Governance Committees) and strategic and operational product plans based on program defined objectives and priorities.

Decision-making and Autonomy

  • Promote visibility and transparency of information within the device development team, across program sub-teams and GPTs to accelerate decision making, obtain alignment, and increase foundational knowledge.

Interaction

  • Individual seeks to understand underlying issues/needs and proactively engages the customer in development or identification of solutions, products or services. Incumbent sets high standards for him/herself and obtains feedback to ensure the standards are met.

  • Internal – Device Clinical Lead; GMSGQ; GPL and POL; Other members of cross-functional Device Team (GDT); Members and leaders of various functions (Pharm Sci R&D, GMS, Finance, Marketing etc.) across the organization; External vendors, CMOs, and partners.

Innovation

Complexity

  • Provide technical leadership on multiple projects in parallel.

  • Drive the evaluation of complex drug delivery systems and provide sound technical recommendations to move projects forward.

  • Identify, communicate and lead device design control process creation to meet device regulations.

  • Requires high level of problem-solving capability and ability to balance competing priorities and quickly and objectively drive the team towards a path which maximizes value.

  • Routinely requires high level of problem-solving capability and business acumen, ability to balance competing priorities and quickly and objectively drive the team towards a path which maximizes value.

EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Minimum of 12 years of experience in device development and commercialization with demonstrated success leading multi-site, global or enterprise-wide programs in the biotech/pharmaceutical industry.

  • Knowledgeable in at least one functional area (proven experience) in the development of a pharmaceutical device; has to be able to assess validity of overall program/project strategy and deliverables.

  • 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 diversity of therapeutic areas.

  • Strong knowledge and understanding of global device product development and commercialization in the pharmaceutical industry.

  • 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:

  • 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.

  • Bachelor’s degree required, MS desired; MBA or relevant industry experience preferred.

TRAVEL REQUIREMENTS:

WHAT TAKEDA CAN OFFER YOU:

  • 401(k) with company match and Annual Retirement Contribution Plan

  • Tuition reimbursement

  • Company match of charitable contributions

  • Health & Wellness programs including onsite flu shots and health screenings

  • Generous time off for vacation and the option to purchase additional vacation days

  • Community Outreach Programs

Empowering Our People to Shine

Learn more at takedajobs.com.

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Locations

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0027346

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