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- The DDL will be accountable for device program execution ensuring the translation of product development strategy into clear and actionable plans/deliverables.
- The DDL will work closely with Device Program Teams (DPTs) and the drug Global Program Teams (GPTs) as required to ensure alignment of the device strategy and execution.
- The DDL will also work with the Device Project Managers (DPM) to ensure proper planning and execution of the project plan.
- Lead a cross functional team or multiple teams for devices through clinical development, product registration and commercialization. Projects may also include Life Cycle Management (LCM) products that require further development.
- Overall accountability for the creation, management and execution of device development project plans by building consensus within the cross functional teams.
- Drive and manage budgeting process for specific device development plans.
- Monitor and manage overall program risk and communicate as appropriate. Provide risk mitigation solutions to the core team and DPT/GPT.
- Report project status to DPT/GPT and/or PDT leadership committees on a regular basis.
- Promote visibility and transparency of information within the device development team and across cross functional.
- Ensure device development activities align with Takeda’s Stage Gate Milestone framework and support Design Transfer readiness.
Responsibilities
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Lead and drive development and execution of Target Device Profile (TDP) and drug Target Product Profile (TPP) alignment.
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Overall responsibility for the device program planning and execution.
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Develop and lead high performing device development cross functional teams.
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Create, manage and ensure execution of integrated device development project plans by building consensus within the cross-functional teams.
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Drive budgeting process and ensure adequate resource deployment (OPEX/spend, CAPEX and FTE) in support of the approved integrated device development plan.
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Monitor the overall program risk and communicate as appropriate.
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Represent Device development team at Takeda’s product governance bodies incl. GPT, PDT (Plasma Derived Therapies business unit) among others.
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Facilitate preparations and analyses related to device relevant business reviews, scenario planning and routine evaluation processes, and progress against strategy and action plans.
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As appropriate, collaborate and communicate with GPTs and other cross-functional governance bodies to evaluate device related product/program opportunities and develop integrated execution plans based on strategic objectives.
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Provide clear direction on device program requirements in alignment with the Product/Device operating model to meet expectations of external customers and business stakeholders.
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Collaborate with global commercial teams to align device strategy with market needs and launch readiness.
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As need, support digital health initiatives by integrating connected care capabilities into device development plans.
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Oversee quality assurance activities and ensure compliance with internal SOPs and external regulatory standards.
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Manage multiple program teams as needed with a high-level view of program impact on GPT, DPT and organizational strategy.
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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, Clinical Science, Clinical Operations, Quality Assurance, Procurement, Business Development, Research and brand teams.
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Facilitate execution of the global device program strategy.
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Lead and drive development and execution of strategic device plans, Long Range Plan, Life Cycle Management (LCM) Plan and geographic expansion plan, ensuring alignment to program strategy.
Education and Experience Requirements
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BS/BEng in relevant engineering or scientific area of study with minimum twelve (12+) years of relevant experience.
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Relevant experience is in device development and commercialization with demonstrated success leading cross functional, 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.
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In particular, end-to-end development experience with medical device capital equipment is required.
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Proven Leader with ability to manage multiple complex cross-functional teams and processes to deliver key accountabilities.
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Demonstrated experience managing programs in different stages of development in many therapeutic areas.
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Strong knowledge and understanding of global device product development and commercialization in the pharmaceutical industry is preferred.
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Strong understanding of the relevant regulatory frameworks that govern devices across the product lifecycle.
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Strong understanding of the business environment and relevant key strategic, operational drivers and competitive environment.
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Excellent knowledge and application of elements of device-related product development and the relevant quality management systems.
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Excellent knowledge and execution of subcontractor management and CMOs.
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Strong understanding and competency in planning processes and decision making.
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Demonstrated experience using standard program management tools and software including integrated development plans, timelines, risk management, and budget development and monitoring.
Key Skills, Abilities, and Competencies
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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.
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Lead device program teams by building consensus within the team and DPTs/GPTs.
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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.
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Well versed with medical device product development process and FDA/EU MDR guidelines. Familiar with Microsoft Project; demonstrated versatility in operations / program management tools to facilitate functional and geographic collaboration and maximize team effectiveness.
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:
$154,400.00 - $242,550.00
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.
Lexington, MA
Employee
Regular
Full time
Job Exempt
Yes
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
