Early Technologies - Device Development Portfolio Lead

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Job Description

Primary Duties

The Early technologies

• Device Development Portfolio Lead (DDPL) position is a high impact leadership role responsible for leading and coordinating the development of the product device strategy, including technology/platform choice, partner/vendor selection, clinical strategy, regulatory strategy, etc. for multiple assets or therapy areas across the entire product lifecycle. The DDPL will also be expected to serve as the program lead on various early technology assessment projects. They will be accountable for device program execution ensuring the translation of product strategy into clear and actionable plans/deliverables.

The Early Technology

• DDPL role requires a talented leader with proven expertise in understanding the unmet stakeholder needs, strategizing innovative solutions, and evaluating the technology solutions. They will be overseeing cross-functional, global team activities and is expected to be knowledgeable about the overall device development activities.

The early Technology

• DDPL will also work closely with upstream marketing and Global Program Teams (GPT's) and GMS Product Teams as appropriate to ensure that the device strategy is in sync with the GPTs' and GMS Product team's needs.

Responsibilities

Job Function and Description

30%

• Work with cross functional teams to monitor the health of early technology programs, evaluate program risks, interdependencies and ensure adequate communication across all stakeholders.

• Ensure that adequate communication is maintained outside the device team for the early technology programs under their responsibility.

• Represent the Device development team on any new GPT to ensure that appropriate devices technologies are considered for the therapy and all device related activities are in sync with their strategies.

• Maintain overall responsibility for timeline, budget and risk management of the portfolio of programs under their responsibility.

30%

• As a DDPL, facilitate 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 (LCM) Plan and geographic expansion plan, ensuring alignment to program strategy.

• 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 (spend, CAPEX and FTE) in support of the approved integrated device development plan

• The DDPL 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 (LCM) Plan and geographic expansion plan, ensuring alignment to program strategy.

• 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 (spend, CAPEX and FTE) in support of the approved integrated device development plan

40%

• Supports identification of novel delivery and management devices for patients with complex, rare diseases.

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

• Contribute to Takeda's PDT BU device strategy as required

• Conducts market as well as technology landscaping exercise in support of device strategy.

• Support device relevant BD activities as required

• 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, Quality Assurance, Procurement, Business Development, Research and the brand teams.

Key Skills, Abilities, and Competencies

• 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.

• Ability to evaluate multiple, sometimes conflicting inputs, determine trade-offs and drive decisions while maintaining accountability of the various stakeholders

• Lead device program teams by building consensus within the team and manage execution to project plans.

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

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

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

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

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

• Able to challenge portfolio-wide /project/program assumptions to resolve conflicts, optimize schedule, costs and quality. Ensure alignment of asset goals and objectives.

• Familiar with Microsoft Project; demonstrated versatility in operations / program management tools to facilitate functional and geographic collaboration and maximize team effectiveness.

• Fluent (spoken and written) in English.

Complexity and Problem Solving

• Provide program leadership on multiple projects in parallel.

• Proactively monitor program risk and provide alternate scenarios to mitigate them without compromising on strategic objectives

• 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.

• This role requires the incumbent to think strategically and tactically and be able to present recommendations to senior leaders and key stakeholders.

Internal and External Contacts

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 Contacts:

• PDT leadership and other cross-functional governance bodies

• GPT and GMS PT functional representatives

• Other members of cross-functional Device Team

• Members and leaders of various functions (Device Engineering, Pharm Sci., Regulatory Affairs, Device Quality, , Finance, Marketing etc.) across the organization

External Contacts:

• Vendors, CMOs, and other partners

Education and Experience Requirements

• BS/BEng in relevant engineering or scientific area of study with minimum eleven (10+) years relevant experience.

• MBA preferred

• Non engineering or scientific degrees may be appropriate if experience is relevant and sufficient to meet the above requirements.

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

• 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 relevant regulatory frameworks that govern device and drug-device combination products across the product lifecycle.

• Strong understanding of the business environment and relevant key commercial, 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.

Other Job Requirements

Travel up to 20% may be required

WHAT TAKEDA CAN OFFER YOU:

• Comprehensive Healthcare: Medical, Dental, and Vision

• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

• 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 and company match of charitable contributions

• Family Planning Support

• Flexible Ways of Working

• Tuition Reimbursement

MORE ABOUT US:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

#Li-Hybrid

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time