Device Development Lead, Senior Manager

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Job Description

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 a part of the device development team based in our Lexington MA office, you will report to the Head of Device Development and lead the planning and execution of device development programs. You will also coordinate technology/platform choice, partner/vendor selection, clinical strategy and regulatory strategy for one or more assets or therapy areas across the entire product lifecycle.

How you will contribute:

• Lead and the development of Target Device Profile (TDP) and TPP alignment

• Overall responsibility for the device program planning and execution

• Create execution of integrated device development project plans

• Guide budgeting process and ensure resource deployment (spend, CAPEX  and FTE) to support the approved integrated device development plan

• Facilitate preparations and analyses related to device relevant business reviews, scenario planning and routine evaluation processes, and progress against strategy and action plans

• Communicate with GPTs and other governance bodies to evaluate device related product/program opportunities and develop integrated execution plans based on strategic goals

• Provide clear direction on device program requirements according to the Product/Device operating model to meet expectations of external customers and business stakeholders

• Demonstrated experience in cross functional stakeholder management to drive decisions and evaluate project risks

Minimum Requirements/Qualifications:

• BS/BEng in relevant engineering or scientific area of study with 9 years of relevant experience

• Demonstrated experience in cross functional stakeholder management to drive decisions and evaluate project risks

• Relevant experience in device development and commercialization with experience leading cross functional, global or enterprise-wide programs in the biotech/pharmaceutical or medical device industry

• Relevant experience in device development and commercialization with experience leading multi-site, global or enterprise-wide programs in the medical device or biotech/pharmaceutical industry

• Understanding of global device product development and commercialization in the pharmaceutical industry

• Demonstrated experience using standard program management tools and software including integrated development plans, timelines, risk management, and budget development and monitoring

• Experience with the 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

• 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.

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