Posted to MedZilla on 1/19/2020

Takeda Pharmaceuticals

US-MA, Global Regulatory Operations Cross-Functional Optimization Associate Director R0012481-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 a Global Regulatory Operations Cross-Functional Optimization Associate Director in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Director working on the Global Regulatory Operations team, you will be empowered to successfully manage and deliver important operational optimization improvements via people, process and technology, and a typical day will include:


  • Incumbant will use Project Management and process improvement methods in collaboration with stakeholders. The goal of such projects will be to achieve a meaningful improvement in performance (productivity, efficiency, effectiveness). The projects will involve at least two of the following areas: clinical development operations, pharmacovigilance, regulatory affairs, or pharmaceutical supplies. Expected to contribute to the identification of key opportunities for cross-functional optimization. The role will require someone who is hands on and able to effectively lead high- performance teams without having direct line authority
  • Effectively communicates the rationale for cross-functional optimization strategies and executes and translates these plans into tactical plans
  • Fosters a cross-functional excellence mindset through educating, coaching and mentoring colleagues at all levels of the business in process improvement techniques


  • Leads and successfully delivers multiple complex cross-functional optimization projects, such that the business achieves a step change in performance (productivity, efficiency, effectiveness). The projects will involve at least two of the following areas: clinical development operations, pharmacovigilance, regulatory affairs, or pharmaceutical supplies.
  • Manages resourcing; builds matrix teams and reports project status to stakeholders and Sr. Management on a regular basis
  • Surveys the external environment to keep abreast of industry advances in technologies affecting Clinical Development Operations, Clinical Supplies, Regulatory Affairs, and Pharmacovigilance to encourage further innovation to Takeda
  • With oversight, is able to navigate uncharted territory where no process or precedent exists, while maintaining compliance with internal procedures and industry regulations (GxP)
  • Provide a key role in Integration from the perspective of cross-functional optimization
  • Accountable for ensuring measures for accessing success are implemented and monitored.
  • Participates in strategic discussions and provides recommendations based on analysis with quantifiable opportunities to drive optimization


  • Requires significant subject matter expertise in both core development function (Clinical Development Operations, Regulatory Affairs, GPSE) & Project leadership experience given criticality of aligning cross-functional teams and driving process forward


Technical/Functional (Line) Expertise

  • Comprehensive understanding of the pharmaceutical industry and 12+ years experience in one or more of the following areas: clinical development operations, pharmacovigilance, regulatory affairs, or pharmaceutical supplies
  • Project-management expertise, demonstrated ability to lead multiple, complex projects from inception to close-out


  • Demonstrated ability to work across functions, regions and cultures
  • Functional level leadership with the ability to inspire, motivate and drive results
  • Outstanding communicator, able to persuasively convey both ideas and data, verbally and in writing
  • Proven skills as an effective team player who can engender credibility and confidence within and outside the company
  • Ability to distil complex issues and ideas down to simple comprehensible terms
  • Demonstrates senior leadership presence and confidence
  • Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization
  • Builds teams across functions and geographies with individuals who have the right skills and experience to deliver on key organizational initiatives.
  • Invests time in helping others to enhance their skills and perform at a higher level

Decision-making and Autonomy

  • Decision making responsibilities:
    • Provide input to highly complex decisions that impacts across functional areas
    • Accountable for decision making for designated function
    • Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions
    • Ability to incorporate feedback and ensure decisions are implemented swiftly to yield flawless execution
  • Accountable for providing inception of and implementing vision and strategy for designated scope


  • Expertly navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace
  • Cultivates a broad network of relationships throughout Takeda, with affiliates and external partners, in the industry and area of expertise.
  • Effectively represents function in negotiations with the ability to resolve conflict in a constructive manner
  • Ability to build strong relationships and collaborate effectively with other interfacing Takeda functions


  • Forward thinking with the ability to recommend, influence and implement organizational change and continuous innovation
  • Comfortable challenging the status quo and bringing forward innovative solutions
  • Ability to take risks implementing innovative solutions, accelerating time to market
  • Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business.
  • Role models respect and inclusion, creating a culture that fosters innovation


  • Ability to work in a global ecosystem (internal and external) with a high degree of complexity
  • Deep expertise required
  • Ability to see and understand broader, enterprise level perspective


  • Bachelor s degree or related experience is required. Scientific or closely -related field preferred; Advanced degree preferred
  • 8+ years of experience in the pharmaceutical/biotechnology industry with 6+ years direct leadership experience in at least one of the following: clinical development, pharmacovigilance, regulatory affairs or clinical supplies
  • Demonstrated experience leading teams, managing and mentoring colleagues.
  • Experience in global drug development and in R&D operations or related field, leading a medium to large organization and influencing senior-level management and key stakeholders
  • Proven track record of leading and driving high performing teams and/or process improvement intitiatives as well as delivering on projects
  • Six sigma, LEAN, and/or PMP certification or equivalent desirable
  • Experience with applying knowledge of drug development and process improvement, involving undefined frameworks with medium technical complexity and defined scope.
  • Demonstrates leadership, problem-solving ability, flexibility and teamwork.
  • Exercises sound judgement in elevating and communicating actual or potential issues to line management.
  • Project Management qualification is strongly preferred
  • Excellent written and oral communication skills required.
  • Demonstrates leadership, problem-solving ability, flexibility and teamwork.
  • Excellent written and oral communication skills required.
  • Active participation in Industry groups/forums expected.
  • Demonstrated ability to work well within a matrix structure in a complex environment


  • 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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Cambridge, MA

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