Skip to main content

求人検索

プロフィールを使用して検索

Global Lead, Evidence Generation Operations

応募 後で応募 求人ID R0011430 掲載日 08/29/2019 Location:Boston, Massachusetts; Lexington, Massachusetts

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that I agree with Takeda’s Privacy Notice, Privacy Policy and Terms of Use.

Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Group Lead (GL), GMA (Global Medical Affairs) Evidence Generation Operations  team in our Cambridge, MA office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

OBJECTIVES/PURPOSE:

  • Oversight for all GMA related research studies and trials including the Medical Affairs Company Sponsored (MACS) study program, the Takeda Investigator Initiated Research (IIR) program and the Takeda Collaborative Research program. In this role the GL is accountable for ensuring that GMA research programs are initiated in accordance with all applicable internal and external legal, compliance and regulatory guidelines. Furthermore, oversees the conduct of the programs and ensures compliance by collaborating with the appropriate internal partners.
  • Accountable for deploying, leading, and directing a research function and ensuring optimal use of internal and external resources in order to support all global, regional and local Medical Affairs research  and product programs. Oversees all related policies, processes, systems and budgets.

  • The focus of the role will be to lead and manage a team that works across GMA Therapeutic Areas (TA) and functions in transforming medical strategy and plans into dependable high-quality deliverables:

ACCOUNTABILITIES

  • Oversee the conduct of the GMA external research program for sponsored trials, collaborative research and IIR studies. Provides expert guidance, consultation and support as needed for regional and Local Operating Company (LOC) research activities.
  • Ensures a patient centric approach to GMA post-registration value evidence generation by partnering closely with R&D and patient advocacy groups.
  • Oversee and coordinate the capture, archiving and reporting of appropriate patient safety information from GMA run clinical trials. Ensure coordination with Pharmacovigilance and Regulatory Affairs to respond to external audits and requests from external regulatory bodies. 

  • Partners with GMA TAHs, MU Leads and Functional Heads to support translation of medical strategy into executable operational plans

  • Oversees the development and implementation of processes, systems and tools to enable efficient delivery, tracking, visualization and communication of GMA activities (i.e. scorecards, dashboards)

  • Facilitates alignment with other business functions within the organization, particularly the GPTs, Regions/BUs and R&D to ensure consistency in understanding of asset level priorities

  • Leads the risk/issue management process and proactively collaborates with appropriate leaders to deliver risk mitigation plans

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

  • Comprehensive understanding of the pharmaceutical industry and Medical Affairs 
  • Global regulatory expertise with demonstrated strong ability for collaboration and team leadership; experience leading and working with cross-cultural teams.
  • Therapeutic expertise

Leadership

  • Demonstrated ability to work across functions, regions and cultures
  • Enterprise level leadership with the ability to inspire, motivate and drive results
  • Excellent 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
  • Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization

Decision-making and Autonomy

  • Broad decision making responsibilities:

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

  • Comprehensive understanding of the pharmaceutical industry and Medical Affairs 
  • Global regulatory expertise with demonstrated strong ability for collaboration and team leadership; experience leading and working with cross-cultural teams.
  • Therapeutic expertise

Leadership

  • Demonstrated ability to work across functions, regions and cultures
  • Enterprise level leadership with the ability to inspire, motivate and drive results
  • Excellent 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
  • Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization

Decision-making and Autonomy

  • Broad decision making responsibilities:
    • Ability to make highly complex decisions that impact the enterprise
    • Accountable for decision making for Regional Evidence Generation Operations function
    • Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions
    • Ability to incorporate feedback and ensure decisions are made swiftly to yield flawless execution 
  • Accountable for designing and implementing vision and strategy for designated scope

Interaction

  • Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace
  • Ability to effectively implement R&D’s partnership strategy
  • Effectively represent Takeda in High-level negotiations with the ability to resolve conflict in a constructive manner
  • Ability to build strong partnerships and drive role clarity with other interfacing Takeda functions, including but not limited to TAs, Bus, GPSE, LOC, Market Access, GOR

Innovation

  • Visionary and forward thinking with the ability to influence and effectively drive 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

Complexity

  • Ability to work in a global ecosystem (internal and external) with a high degree of complexity
  • Knowledge required across therapeutic areas, indications, and/or modalities
  • Experience operating in a multi-disciplinary drug development environment including international experience and exposure to a variety of therapeutic areas.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: 

  • Bachelor’s and MSc degrees in relevant subject required.
  • Pharmacist, PharmD, PhD or MD preferred
  • 8+ years combined experience in pharmaceutical industry, and academic research, or healthcare management. 
  • Management experience in Global Medical Affairs or related field
  • Previous experience in Medical Affairs Operations strongly preferred, clinical operations considered
  • Health care business acumen with a comprehensive understanding of the pharmaceutical industry

ADDITIONAL INFORMATION

  • Manual dexterity required to operate office equipment (i.e. computers, phones, etc.)
  • Ability to sit for long periods of time
  • Carrying, handling, and reaching for objects
  • 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:

  • 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

Discover more at takedajobs.com

No Phone Calls or Recruiters Please.

#LI-TL1

Locations

Boston, MA

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

応募 後で応募