Director, Operational & Systems Excellence

Company: Takeda Pharmaceutical
Location: Bronx
Posted on: May 12, 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, Operational & Systems Excellence where you will lead a team that works across Global Medical Affairs (GMA) Therapeutic Areas (TA) and functions ensuring high-quality deliverables. You will also ensure a consistent process and quality for evidence generation operations is implemented across all therapeutic areas (TA). Oversee administration and proper use of GMA-related research IT system/digital applications, such as iEenvision, CTMS, Nexus, FMV tools, and ensures compliance by collaborating with the appropriate internal partners. Partner with Business Solutions & Analytics to provide information to the business such as metrics and KPIs. You will partner with the regions for training and disseminating evidence generation operational excellence, which includes best practice sharing. Support the development of evidence generation policies and SOP trainings. As part of Global Medical Evidence, you will report to Head, Global Medical Evidence and work with the Global Medical Evidence team.How you will contribute:

• Oversees the development, implementation, administration and proper use of processes, systems and tools to enable efficient and compliant delivery, tracking, reporting and communication of Takeda Medical Affairs evidence generation.
• Facilitates alignment with other business functions within the organization, particularly the GPTs, Regions/BUs and R&D to ensure consistency in understanding and implementing of asset level research and data standards.
• Oversees processes, systems and activities related to data curation and generation from a variety of internal and external sources to ensure data are centrally maintained, managed and available for stakeholders to access in real-time.
• Supports evidence generation planning and excellence by development and implementation of tools, innovative approaches and collaborations with other business functions.
• Support strategies and activities to ensure best practices are maintained across evidence generation and integration activities across TAs and Global, Regional and LOC Medical Affairs Units.
• Participate as a research functional expert on cross-functional leadership teams.
• Ensure support is provided to audits and inspections as applicable to medical evidence generation related IT systems/digital application and processes.
• Deep understanding of regulations for real-world data in USA, Europe and RoW
• Comprehensive understanding of the pharmaceutical industry and Medical Affairs
• Global regulatory expertise with demonstrated ability for collaboration and team leadership; experience leading and working with cross-cultural teams.What you bring to Takeda:
  • An advanced degree in a health sciences related field is required, with PharmD, PhD or MD, or geographic equivalent, preferred.
  • 8 or more years in Medical Affairs, Clinical Research within a biopharmaceutical industry setting.
  • Experience leading teams in Medical Evidence Generation Operations
  • An understanding of research methodology and its application to medical research planning.
  • Experience with the key regulations worldwide governing research in humans
  • Superior communication, strategic, interpersonal and negotiating skills
  • Proactively predict issues and solve problems
  • Drive decision-making within a multi-disciplinary, multi-regional, matrix teams
  • Diplomacy and positive influencing abilities
  • Ability to drive or fly to various internal and external meetings.
  • Required travel approximately (10 - 20%), including international trips, overnight stays, and some weekend commitments.What 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 policyIn accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
      #LI-RMEEO 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.LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Takeda Pharmaceutical, New Rochelle , Director, Operational & Systems Excellence, Executive , Bronx, New York