BioSpace

Seen as subject matter expert in global medical device commercialization including P&L management, strategy/ planning, upstream & downstream device marketing, portfolio planning & management, device commercialization, digital marketing, life-cycle management, market development, reimbursement, sales/customer support, communications, etc.. Develop external vendor management strategy (when to outsource/insource) to effectively manage and collaborate with contract manufacturers, distribution partners, and marketing agencies, to support the commercialization of medical devices.. U nderstanding of global regulatory requirements applicable to medical devices, such as FDA (United States), EU MDR (European Union), PMDA (Japan), and other regional regulatory frameworks.. PDT and/or Rare Disease experience preferred.. This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

commercialization

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Head of Global Device Strategy Commercialization Cambridge, MA OBJECTIVES/PURPOSE Takedas PDT BU Global Portfolio Strategy Organization is responsible for developing and executing innovative and transformative strategies for pipeline and in-market assets across Immunology, Hematology and Specialty Care therapeutic areas. As part of the PDT ecosystem, GPS will leverage data, digital, devices, and other technologies to bolster awareness, create value, and acceleration adoption of new and existing therapeutic solutions while reducing administration burdens and improving experiences for patients and other key stakeholders. This position be responsible for owning the device strategy and driving global launch excellence and commercial execution of this strategy for new and innovative device and technology solutions aimed at improving administration of plasma-derived therapies for patients., This role will drive the short, mid, and long term execution of the global strategy across functions and regional commercial teams. Purpose-filled innovation and RWE generation resulting in increased value recognition for pipeline and portfolio assets are deliverables of the overarching Global Device Strategy. This position is responsible for all strategic and commercialization activities as well as cross-functional, regional collaboration associated with the global conventional device platform from concept generation, pre-launch readiness to commercialization and post-approval marketing execution. Experience partnering with R&D and regulatory bodies is crucial as it enables effective collaboration between different functions and ensures the successful commercialization of regulatory-compliant devices. By possessing the ability to bridge the gap between commercial strategies, device development, and regulatory compliance, this position will drive successful market launches and sustained growth across global markets where we extended PDTs to address patient needs. Additionally, partnering with external vendors is essential to ensure seamless execution of commercial strategies and successful device launches. By effectively managing relationships, leveraging vendor expertise, and collaborating closely with internal / external partners, this position will drive efficiency, quality, and overall success when bringing medical devices to market. ACCOUNTABILITIES Develop and implement global go-to-market strategies, positioning, messaging, and marketing plans to drive successful device adoption. Partner with R&D on the early stage concepts (ideation, screening, business case, etc.) and represent the interests of internal as well as external stakeholders. Seen as subject matter expert in global medical device commercialization including P&L management, strategy/ planning, upstream & downstream device marketing, portfolio planning & management, device commercialization, digital marketing, life-cycle management, market development, reimbursement, sales/customer support, communications, etc. Accountable for developing a rigorous skilled in business analysis, pricing methodologies, market/ competitive research frameworks to ensure Local Operating Companies align and optimize business and technology priorities. Build frameworks and disciplines on how we identify market opportunities, conducting market analysis, and making data-driven decisions to capitalize on market trends. Partner with the Head of Device Development as well as early GPTs to identify opportunities and challenges, remove barriers and act as the voice of global commercial teams, providing feedback to meet launch objectives and timelines. Establish and manage post launch KPIs and monitoring. Translate customer feedback into device design and launch strategies, identify opportunities for improvement, and collaborate with internal stakeholders to enhance devices and services. Develop external vendor management strategy (when to outsource/insource) to effectively manage and collaborate with contract manufacturers, distribution partners, and marketing agencies, to support the commercialization of medical devices. Build strong vendor relationships, ensuring compliance with quality standards and agreed-upon timelines, and proactively addressing issues or challenges that arise. Align commercial strategies with R&D objectives, ensuring market needs and opportunities are incorporated into device development plans. Provide commercial input during the regulatory review process, and advocating for the commercial viability of devices while ensuring adherence to regulatory guidelines. Build strong stakeholder relationship and collaborate with in/external Quality teams to implement and maintain compliant processes, conduct risk assessments, and ensure devices consistently meet or exceed safety and reliability standards. Establish forecasting demand operating mechanism by collaborating with internal stakeholders and external suppliers to ensure adequate device availability, and managing any potential supply chain disruptions to minimize impact on the commercialization process. DIMENSIONS AND ASPECTS Technical/Functional Expertise Strong background in commercial strategy and leadership within the medical device industry or related field. Previous experience in global commercial roles, managing global markets and driving strategies for device launches and market entry. Expert at developing and executing traditional marketing and go-to-market launch activities such as product positioning statements, brand position, brand plans, trademarking, marketing materials for the device accessories/ PFS, affiliate launch prep checklist, affiliates training, and other core marketing and launch tools that are intended to drive adoption and loyalty. Deep understanding of the medical device landscape, including regulatory requirements, reimbursement processes, and industry trends. Experience in leading global device launches, from planning and execution to post-launch monitoring and optimization. Expertise in conducting market assessments, identifying target customer segments, and developing tailored marketing campaigns to drive device success. Track record of working closely with cross-functional teams, particularly R&D departments, to provide commercial insights and guidance during device development phases. U nderstanding of global regulatory requirements applicable to medical devices, such as FDA (United States), EU MDR (European Union), PMDA (Japan), and other regional regulatory frameworks. Familiarity with supply chain management principles and the ability to collaborate with external supply chain teams to optimize inventory management, distribution networks, and logistics planning for global commercial operations. Strong financial Acumen and the ability to manage budgets, analyze financial data, and understand profitability metrics such as COGs and the impact on ROI and NPV is required. Experience in selecting and onboarding vendors, negotiating contracts and service-level agreements, and ensuring seamless coordination and alignment between internal teams and external partners. Mastery understanding and experience with worldwide Regulatory submissions and approval processes as well as global launch and commercialization requirements. Demonstrated ability to develop and execute global commercial strategies that drive revenue growth and market penetration. Experience in assessing competitive landscapes, conducting target market and as well as concept market research, and using insights to inform strategic planning and positioning of devices. Interactions Experience in managing and mentoring a team of diverse commercial professionals, fostering a collaborative and high-performance culture, without direct authority Proven ability to effectively communicate and influence stakeholders at all levels of the organization, including executive leadership. At ease when partnering and collaborating with financial teams, setting pricing strategies, and making data-driven decisions that align with business unit financial objectives Strong understanding of customer needs and the ability to translate customer insights into effective commercial strategies. - Skilled in building and maintaining strong relationships with key customers, partners, and opinion leaders to drive device adoption and market expansion. Experience working in a global or multi-national organization, with an understanding of cultural nuances, regulatory differences, and commercial dynamics across various regions. Ability to navigate and adapt to different markets, understanding the varying needs, preferences, and challenges associated with each region. Innovation Familiarity with agile development methodologies and iterative feedback loops to optimize device features and functionality based on customer feedback and market demands. Familiarity with Quality Management Systems (QMS) and Quality Assurance principles to ensure devices meet regulatory, quality, and safety standards. EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: BSc in pharmacy, science, business, or related field required, advanced degree a plus. 10+ years of business experience in the Pharmaceutical, Biotech and or Healthcare business-to-business or consultancy originations is ideal Solid background and proven experience in commercialization of medical devices and digital technologies. Sales, Marketing, and/or New Product Planning experience required. US Payor and Device Reimbursement experience required. Mastery knowledge of business case development to include strong analytics, technology, marketing, and financial acumen. Excellent strategic agility underlined by agile project and process management. Broad and deep knowledge of key pharmaceutical functions to include understanding of global drug development, regulatory, and commercialization processes. Deliver top performance operating in a matrix environment. PDT and/or Rare Disease experience preferred. Ig sales experience a plus. Proven stakeholder management and engagement at all levels of the organization. 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. #LI-hybrid 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: Boston, MA U.S. Base Salary Range: $205,100.00 - $322,300.00 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-termincentives. 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 Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time #J-18808-Ljbffr

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