Director/Sr Medical Director, Head of Medical Review

  • Company: Takeda
  • Location: Cambridge, Massachusetts
  • Posted: December 13, 2017
  • Reference ID: 1703365
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 a Senior Medical Director, Head of Medical Review in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Medical Director working on the Global Patient Safety team, you will be empowered to Innovate and Collaborate. A typical day will include:


  • Oversee Medical Review for Takeda within Global Patient Safety Evaluation (GPSE); implement an operational strategy ensuring quality and timely medical review of cases reported and managed within the Global Safety Database (GSDB)
  • Lead the transition of the current model of Medical Review to a future state with vendor support; work directly with vendors to ensure an optimized operating model for Medical Review and contract and regulatory compliance
  • Ensure that GPSE Medical Review processes are continuously improved to reflect regulatory trends/guidelines, represent best practices, are efficient and align with the GPSE governance and vendor model
  • Establish a culture of excellence in Medical Review and ensure that members of the Medical Review team are provided with the appropriate development and management to provide thoughtful and medically accurate review of cases


  • Develop and execute the overall vision and strategy for Medical Review in GPSE
  • Collaborate closely with vendors and other department teams to develop/maintain a streamlined approach to Medical Review in the future state
  • Represent Takeda Medical Review in vendor governance activities; provide vendor oversight for Medical Review including, but not limited to:
    • Leading and facilitating regular Medical Review operating committee meetings to review / address issues as needed for:
      • Adherence to KPIs and SLA
      • Forecast demand
      • Issue escalations
      • Continuous improvement initiatives
      • Change management
    • Representing the voice of the Medical Review vendors to the GPSE function
    • Leading Medical Review change management and ongoing training
  • Partner with the Case Processing team to ensure a single mechanism for data entry and medical review of cases with the highest quality and timely submission
  • Provide leadership and medical expertise to ensure consistency of high quality and timely medical case assessment across all therapeutic areas (e.g., Oncology, GI, CNS, Marketed Products, and Vaccines)
  • Represent Medical Review during inspections and audits
  • Educate members of GPSE and as indicated, cross-functional product teams and the larger Takeda organization on the discipline of Medical Review and the surrounding regulatory environment
  • Facilitate links with Regulatory Intelligence and industry organizations to ensure cutting edge knowledge and application of Medical Review best practices
Excellence in Medical Review/Processes
  • Oversee of Medical Review across all therapeutic areas
  • Provide medical guidance to case assessments as needed
  • Lead the Medical Reviewers in any activities to provide leadership within GPSE and the cross-functional product teams
    • Address questions about coding and expectedness during case processing in collaboration with Medical Safety, as needed
    • Participate on the MedDRA coding committee
    • Input into Data Handling Conventions, with focus on harmonization, as appropriate
    • Argus activities
  • Contribute to KPIs/metrics as applicable as part of oversight of Medical Review
  • Ensure that all Takeda Medical Review processes reflect best practices and current regulatory trends
  • Update SOPs or other functional documents as needed, confirming that they are aligned with global processes, and minimize duplication
  • Confirm that training for Medical Reviewers reflects the processes for high quality and timely medical review are consistent with Takeda SOPs
Culture and Environment
  • Dedicate expertise and time to provide strong leadership/management to the Medical Review team to promote engagement and collaboration
  • Establish strong presence of the Medical Review team in GPSE and the larger Takeda organization


  • Medical degree (MD or equivalent) required
  • Minimum of 10 years of pharmaceutical industry experience, with at least 6 years in Medical Review
  • Leadership/management experience required
  • Experience working in a safety database such as Argus or equivalent required
  • Experience collaborating with vendors strongly preferred
  • Strong knowledge of regulations and practices governing Medical Review and case submission
  • Ability to work across multiple therapeutic areas
  • Clear understanding of how medical case review may contribute to other PV activities such as signalling, risk translation/minimization, etc.
  • Capacity to manage time and multiple priorities simultaneously in a high pressure, often time-constrained environment
  • Insights required to work productively in global company and with multiple vendors, taking proactive interactions necessary to achieve business goals and objectives
  • Ability to relate well to people and to motivate and empower others
  • Communication with clarity and brevity
  • Ability to lead meetings and teleconferences, both internally in Takeda as well as externally with Medical Reviewers and vendor leadership
  • Attention to detail


  • Some domestic and international may be required on an infrequent basis

  • 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

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Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit

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