Device Development Lead, Senior Manager

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About the role:

Plasma-derived therapies are critical, life-saving medicines, which patients with rare and complex diseases around the world rely on every day. Global demand for these therapies, particularly immunoglobulins, has increased dramatically over the last 15 years, and continues to grow. Takeda is established as second largest provider of plasma-derived therapies (PDT) globally. Leveraging on 75+ year pioneering legacy, Takeda believes there is tremendous potential to do more to meet expectations of patients and health care providers with plasma-derived therapies for patients with immunologic, hematologic, autoimmune and other complex diseases.

As part of the PDT Device, Digital Development and Product Strategy organization based in our Lexington, MA office. The Device Development Lead will be accountable for device/drug-device combination product programs execution ensuring the translation of product development strategy into clear and plans and deliverables. You will work with Device Development Portfolio Leads (DDPL) and the Global Program Teams (GPT) to ensure alignment of the device strategy and execution. You will also work with the Device Project Managers (DPM) to ensure planning and execution of the project plan.

How you will contribute:

• Lead and guide development of Target Device Profile (TDP) and TPP alignment
• Overall responsibility for the device program planning and execution
• Develop and lead device development teams
• Create, manage and ensure execution of integrated device development project plans by building consensus within the cross-functional teams
• Provide clear direction on device program requirements according to the Product/Device operating model to meet expectations of external customers and business stakeholders
• Build and maintain relationships with important 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

Minimum requirements/qualifications:

• BS/BEng in relevant engineering or scientific area of study with minimum nine (9) years of relevant experience. Relevant experience is in device development and commercialization with experience leading 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
• Negotiation experience in a complex stakeholder environment
• Experience managing multiple complex teams and processes to deliver key accountabilities
• Demonstrated experience managing programs in different stages of development in diversity of therapeutic areas
• Knowledge of global device product development and commercialization
• Experience with relevant regulatory frameworks that govern device and drug-device combination products across the product lifecycle
• 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
• Understanding and competency in planning processes
• Demonstrated experience using standard program management tools and software including integrated development plans, timelines, risk management, and budget development and monitoring

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 Work Paths
• 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.

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.