Device Development Portfolio Lead, Sr. Manager
📋 Role Overview & Responsibilities
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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 alignmentOverall responsibility for the device program planning and executionCreate execution of integrated device development project plansGuide budgeting process and ensure resource deployment (spend, CAPEX and FTE) to support the approved integrated device development planFacilitate preparations and analyses related to device relevant business reviews, scenario planning and routine evaluation processes, and progress against strategy and action plansCommunicate with GPTs and other governance bodies to evaluate device related product/program opportunities and develop integrated execution plans based on strategic goalsProvide clear direction on device program requirements according to the Product/Device operating model to meet expectations of external customers and business stakeholdersDemonstrated 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 experienceDemonstrated experience in cross functional stakeholder management to drive decisions and evaluate project risksRelevant experience in device development and commercialization with experience leading cross functional, global or enterprise-wide programs in the biotech/pharmaceutical or medical device industryRelevant experience in device development and commercialization with experience leading multi-site, global or enterprise-wide programs in the medical device or biotech/pharmaceutical industryUnderstanding of global device product development and commercialization in the pharmaceutical industryDemonstrated experience using standard program management tools and software including integrated development plans, timelines, risk management, and budget development and monitoringExperience with the relevant regulatory frameworks that govern device and drug-device combination products across the product lifecycleExcellent knowledge and application of elements of device-related product development and the relevant quality management systemsDemonstrated experience using standard program management tools and software including integrated development plans, timelines, risk management, and budget development and monitoring
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.
Takeda Compensation And Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location
Lexington, MA
U.S. Base Salary Range
$133,000.00 - $209,000.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
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
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