Posted to MedZilla HealthCare on 5/21/2018


Takeda Pharmaceuticals

US-MA, Head, Operational Oversight (Clinical Operations) - Vaccine Business Unit R0000424-MZ


 
 

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Job Description

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as Head, Operational Oversight in our Cambridge, Massachusetts office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As Head, Operational Oversight (Director level role) working on the Vaccine Development Delivery team, you will be empowered to make meaningful contributions, and a typical day will include:

  • Leads and directs the oversight of the execution of VBU global clinical programs and works in close collaboration with appropriate functions to ensure translation of strategic directions into operations

  • Responsible for providing expertise to the clinical strategy as defined in the Clinical Development Plan

  • Responsible for providing leadership and for directing Program Operational Oversight Leads (POOLs) and Clinical Project Oversight Managers (CPOMs) to ensure that the execution of clinical studies is in line with the overall clinical program strategy

  • Supports the development of innovative processes and technologies to advance operations and reduce overall operating costs

  • Responsible for ensuring effective interfaces of Operational Oversight Function with Global Product Team, Clinical Program Team and Clinical Trial Teams

  • Responsible for providing oversight of the Early Engagement process and for the implementation and execution of the VBU clinical operating model

  • The assigned VBU clinical programs will be large, complex, high risk and/or of business importance to Takeda, requiring multi-functional leadership experience and skills to achieve program goals.

POSITION ACCOUNTABILITIES:

  • Responsible for the development and oversight of operational timelines and budget for VBU clinical programs

  • Identifies issues that may impact the overall clinical program plan (quality/timelines/cost) and initiates contingency plans as appropriate

  • Responsible for effective communication of operational risks escalated by Clinical Trial Teams that may impact program quality, timelines or budget and ensure contingency plans are in place

  • Provides clinical operations expertise to Operational Oversight Team for the development of study management plans including enrolment models and, risk management plans, financial planning and management, communication plans, and monitoring plans in collaboration with strategic vendors

  • Ensures compliance with procedural documents, SOPs, Code of Federal Regulations, Good Clinical Practices, ICH Guidelines, and all applicable regulations

  • Provides expert operational and strategic input into Clinical Development Plans, study synopses, protocols, and clinical study reports

  • Represents the Operational Oversight function globally as requested in senior management forums and in governance bodies with strategic vendors

  • Acts as a role model for the implementation and execution of the VBU clinical operating model

  • Responsible for the Early Engagement process with strategic vendors for VBU clinical programs, making recommendations for program/study allocation with strategic vendors, and participation in strategic vendor governance, including identification and resolution of program performance issues.

  • Acts as member of the Development Delivery Leadership Team

  • Acts as deputy Head for the Global Clinical Operations group

  • Supports functional strategic initiatives and processes managed by Clinical Services Group

  • Acts as a role model for Takeda s values

EDUCATION, EXPERIENCE, BEHAVIORAL COMPETENCIES AND SKILLS:

    • Bachelor s Degree required, Life Sciences preferred. Advanced degree highly desirable

    • More than 9 years of clinical development or trial experience in the pharmaceutical industry or in a clinical research organization required

    • More than 6 years of clinical trial management in any of Phases I-IV required

    • More than 3 years of line management or matrix management required

    • Phase II/III experience preferred

    • Global/international experience preferred

    • Drug development experience across multiple therapeutic areas preferred

      Knowledge & Skills:

    • Expertise in Code of Federal Regulations, Good Clinical Practices, and ICH Guidelines.

    • Must be able to make strategic decisions for the operational plans within assigned therapeutic area

    • Exhibit excellent independent judgment and have a clear understanding of what issues need to be elevated

    • Excellence in project management and leadership skills

    • Excellent teamwork skills

    • Creative thinking skills

    • Strong negotiation and persuasion skills

    • Excellent self-management, organizational and verbal/written communication skills

    • Enthusiasm for innovative research and ability and desire to learn new approaches and expand core skill set

    • Strong understanding of finance principles and the ability to use financial knowledge to make sound operational decisions

TRAVEL REQUIREMENTS:

  • Requires international travel, including overnight trips

WHAT TAKEDA CAN OFFER YOU:

  • 401(k) with company match and Annual Retirement Contribution Plan

  • Tuition reimbursement

  • Company match of charitable contributions

  • 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

Empowering Our People to Shine

Learn more at takedajobs.com

No Phone Calls or Recruiters Please.

*LI-KB1-USA


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