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Clinical Science Device Lead

Company: Takeda
Location: Boston
Posted on: April 3, 2024

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 Description

Clinical Science Device Lead (Cambridge, MA)

PDT R&D is dedicated to bringing forward new therapeutic approaches based on plasma-derived therapies for patients with rare and complex diseases. Takeda believes there is tremendous potential to do more to meet patients' and health care providers' expectations with plasma-derived and plasma-oriented therapies for patients with immunologic, hematologic, and other complex diseases. Drug delivery devices development that optimizes the patient experience is a core part of our business.

The Clinical Science Device Lead provides oversight of the clinical device team and ensures that device development within PDT includes robust medical input. Participates in a multi-disciplinary, multi-regional, matrix team making highly complex decisions. This individual has responsibility and accountability for integrating the input from various disciplines and external stakeholders (patients, clinicians) to ensure that global development plans will result in the regulatory approval of new devices that meet patient needs across geographies. Applies clinical/medical decision making to development issues. Responsible for conducting safety risk analysis and for integrating this information into the device development process. Success or failure directly translates to the ability of PDT R&D to meet its corporate goals and for Takeda to have future commercial products.

ACCOUNTABILITIES

  • Device Development team participation and guidance
    • Provides direction to the Global Device Development Team (US, EU) regarding medical/clinical interface and requirements of device development plans. Ensures that devices conform to patient needs, and clinical and regulatory requirements.
    • Responsible for the evaluation of new technology in terms of concept and potential safety issues and in clinical testing.
    • Synopsis / Protocol Development, Study Execution, & Study Interpretation
      • Works with the PDT device team to develop study plans, synopses, and protocols for human studies. Oversees study execution to ensure high fidelity study conduct and data collection and on time delivery of study outputs. Plans development strategies in context of medical/clinical significance considering how a given product will fit in with current treatments, standard of care, and unmet medical need. A significant error in judgment may result in loss of approvability and/or commercial viability of a product.
      • Responsible for training and deployment of devices in PDT clinical trials. Serves as an advisor to the medical directors, assoc. med directors, clinical scientists involved in these activities, and accountable to senior company management for the successful completion of device related objectives. For the assigned devices, accountable for the successful completion of projects undertaken - and for pro-active contingency planning / interventions necessary to ensure achievement of related goals.
      • Device Medical Monitoring
        • Oversees device medical monitoring activities, assessing issues related to device safety in terms of potential subject/patient impact. Assesses overall device safety information for studies and compounds in conjunction with Pharmacovigilance. Leads or co-leads the PDT Device Safety Team.
        • External Interactions
          • Directs activities involved in interactions with regulatory authorities/agencies and clinical development and key opinion leaders relevant to devices. Serves as an advisor to the others engaged in these activities and, in the context of these responsibilities, will be accountable to senior leadership for the successful completion of related objectives.
          • Support of Marketed Products
            • For marketed products, partners with Medical Affairs and Commercial team colleagues to ensure accurate labelling, safety updates and robust compliance with all regulatory reporting requirements.
            • Leadership, Task Force Participation, Upper Management Accountability
              • Interacts directly with research division based on pertinent expertise to provide knowledge/understanding of market environment in line with status as PDT R&D scientific content matter expert for devices.
              • Hires, manages, mentors, motivates, empowers, develops and retains staff to support assigned activities. Conducts performance reviews and drives goal setting and development planning.

                DIMENSIONS AND ASPECTS

                Technical/Functional (Line) Expertise

                Leadership
                • Global perspective with a demonstrated ability to work across functions, regions, and cultures
                • Ability to identify potential challenges and opportunities and make recommendations
                • Proven skills as an effective collaborator who can engender credibility and confidence within and outside the company
                • Valuing and promoting differences by embracing and demonstrating a diversity and inclusion mindset and models these behaviors for the organization
                • Invests in helping others learn and succeed
                • Able to influence without authority
                • Demonstrates agile leadership by seeking to understand with the ability to evolve idea as needed.
                  Decision-making and Autonomy
                  • Accountable for making clear business arguments and strategic recommendations leveraging both quantitative and qualitative evidence
                  • Ability to seek diverse input by balancing multiple internal and external multiple stakeholders to drive solutions and set priorities
                  • Ability to incorporate feedback and ensure decisions are made swiftly to enable flawless execution
                  • Develops executable plans and meets budget and deadlines
                  • Builds a culture of data driven decisions
                    Interaction
                    • Organizational savvy and leverages internal network to enable alignment and effective execution in and outside the BU
                    • Valuing and promoting differences by recognizing the importance of connections and brings in key stakeholders to work towards the best possible solutions
                    • Strong communicator, able to persuasively convey ideas verbally and in writing
                    • Exceptional communication, negotiation, presentation, and influencing skills across internal and external stakeholders
                      Innovation
                      • Disruptive thinker with the ability to influence and change how PDT used data to make decisions and set priorities
                      • Continuously challenging the status quo and bringing forward innovative solutions
                      • Ability to identify areas for process and systems innovation and implement change that will enhance the overall effectiveness of the team.
                        Complexity
                        • Delivers solutions to abstract problems across functional areas of the business.
                        • Identifies and solves fundamental issues for major functional areas through assessment of intangible variables.
                        • Recommends key decisions, escalates key issues per agreed governance framework, and persuades key stakeholders through exceptional influencing skills.
                        • Creates clarity of accountabilities in a global and highly matrixed organization, with a high degree of complexity
                        • Ability to provide data that will resolve or simplifies complexity between commercial, operations, and strategy
                        • Resilient and comfortable working through large scale global change management

                          EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
                          • MD, DNP or internationally recognized equivalent plus 5-8 years of clinical and device development experience within the pharmaceutical industry.
                          • Previous experience successfully leading a device development team/matrix team with responsibility for studies in multiple regions. Development experience beyond US/EU is desired.
                          • 501k/NDA/MAA Submission experience preferred
                          • Experience with and demonstrated ability to lead and manage highly trained medical, scientific and technical professionals preferred
                            Skills
                            • Superior communication, strategic, interpersonal and negotiating skills
                            • Ability to proactively predict issues and solve problems
                            • Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams
                            • Diplomacy and positive influencing abilities across multinational business cultures
                              Knowledge
                              • Knowledge in device development and experience with administering chronic treatments to patients using devices; this may include the development and use of devices in the surgical setting.
                              • Regional/global Regulatory requirements
                              • GCP/ICH
                              • Emerging research in plasma derived/related therapies

                                LICENSES/CERTIFICATIONS:
                                • Physician and Surgeon Medical License, Nursing License or equivalent
                                • Certification/s in related specialty area (eg: surgical or interventional radiology, infusion nursing) is desired

                                  TRAVEL REQUIREMENTS:
                                  • Ability to drive to or fly to various meetings or client sites, including overnight trips. Some international travel may be required.
                                  • Requires approximately 20% travel.

                                    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:
                                    $222,600.00 - $349,800.00

                                    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 e mployee s may be eligible for s hort - t erm and/ or l ong- t erm incentive s . 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

Keywords: Takeda, Boston , Clinical Science Device Lead, Healthcare , Boston, Massachusetts

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