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Director, Connected & Software Devices (CSMD) Strategy Lead

Company: Careerbuilder-US
Location: Lexington
Posted on: November 26, 2022

Job Description:

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 Takeda's 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 DescriptionAbout the role:At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.Join Takeda as a Director, Connected and Software Devices (CSMD) Strategy Lead where you will work with internal and external key stake holders toward establishing overall CSMD device strategy's to support Takeda R&D product pipeline development and Takeda's Global Product Team's development and commercial business objectives.You will also will have demonstrated ability to manage top level programs and related sub teams across multiple therapeutic areas, and/or work streams associated with a high degree of complexity.As part of the Drug Product and Device Development team, you will report to Head, Connected / Software Devices & Diagnostic Services and work with key stakeholders.How you will contribute:

  • You will have an advanced understanding of the development and execution of SaMD medical devices as related to pharmaceutical applications, as well as clinical programs that involve assay development that support diagnostic testing devices, novel drug delivery devices and companion diagnostic devices.
  • You will have in-depth knowledge of global regulatory/industry rules and guidance's to drive the strategic approach to SaMD medical device approvals. You will be responsible for critical communication and coordination of planning and workflows across multiple internal organizations including Clinical, Medical, Commercial, Legal, Regulatory, R&D Quality Compliance, Procurement, R&D DPDD, Finance and key external development partners.
  • You will also be responsible for resource planning and the supporting project budget requirements. Effective management of direct reports to meet staffing, workload and identified performance objectives.Responsibilities will include:50%Oversight with an emphasis on strategic planning, implementation and execution of relevant team and work stream program plans or company initiatives in keeping with DPDD - CSMD program and departmental goals.
  • Assess information / decisions from other functions and their impact on new project planning and ongoing project work stream plans.
  • Provide updates and direction to Sr. Management when conflicts, key developments and program scope / direction changes are identified.
  • Work cross functionally to drive the strategy and oversee implementation for CSMD SaMD programs and related departmental initiatives.
  • Identify and evaluate fundamental issues with multiple variables for major functional areas providing solutions and direction.
  • Ensure document and operating standards are established and maintained locally and globally.
  • Oversee selection of external vendors.
  • Participate in/or lead cross-functional teams at corporate or global level. SaMD device development lead reporting to GPT.20%Responsible for the creation and management of budget & forecast for specified project initiatives.
    • Overall responsibility for assigned program budgets, planning and implementation.
    • Oversee budget activities.20%Align skills and resources needed for success; work closely with internal and external stakeholders to leverage and optimize resources.
      • Review and evaluate resource needs and influence for appropriate prioritization of objectives.
      • Provide general direction to cross functional team representatives, as needed.
      • Ensure performance standards are realistically set and attained for internal and external resources.
      • Oversee management of sites and vendors to issuer resolution if necessary.
      • Oversee identification, qualification and selection of strategic partners needed to conduct SaMD device development and other relevant out-sourced activities including approval of MSA, Development SOW, Supply and Services contracts as needed.
      • Align with team members from other functional areas regarding planning, implementation, tracking, analysis and reporting milestones.5%Participate in the SaMD business development and process improvement activities as needed.
        • Under the direction of Sr. Management, participate in due diligence activities.
        • Establish / identify the initiatives that will be targeted for improvement / revision locally and globally.
        • Participate in the development of corporate or organizational policies and authorizes the implementation.5%Participation in DPDD departmental innovation task forces as appropriate.
          • Domestic and International travel will be required.Minimum Requirements/Qualifications:MS degree / related experiences in life sciences, engineering, computer science, healthcare IT for SaMD applications; Phd preferred.
            • Minimum 12 years SaMD global industry programs experience.
            • Minimum 5 years direct project management experience in clinical research or medical devices programs, including leading and/or managing staff and/or project teams directly.Preferred:
              • Experience building software as a medical device product/programs focused on a global market
              • Experience managing contract medical manufacturers with a cloud connectivity component
              • Experience with online portals and smartphone apps that accompany wearable or personal use devices and connect to a centralized cloud data baseWhat 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 reimbursementMore 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.Base Salary Range: $160,300 to $ $229,000, based on candidate professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.#LI-Hybrid#LI-AA1EEO StatementTakeda 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.LocationsLexington, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Careerbuilder-US, Lexington , Director, Connected & Software Devices (CSMD) Strategy Lead, IT / Software / Systems , Lexington, Kentucky

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