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Associate Director, Operations and Management, Digital Clinical Devices and Technologies

Cambridge, Massachusetts

Overview

Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.

As one of the world’s leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines. The Greater Boston Area is headquarters to many of our Global and US business units.

We are a passionate team doing important work that impacts patients’ lives. If you are driven to create better health and a brighter future, join us!

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Success

What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Collaborative
  • Strategic
  • Results Driven
  • Team Player
  • Versatile
  • Entrepreneurial

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Opportunity

  • Innovation

    Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Values-Led

    Since 1781, the values of Takeda-ism (Integrity, Fairness, Honesty, and Perseverance) have guided everything we do—from decision-making to interacting with patients.

  • People-First

    Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

  • Empowerment

    Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

  • Collaboration

    A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Top Workplace

    Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2018.

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Associate Director, Operations and Management, Digital Clinical Devices and Technologies

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Job ID R0006835 Date posted 01/18/2019 Location Cambridge, Massachusetts

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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 an Associate Director, Operations and Management, Digital Clinical Devices and Technologies in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Director, you will be empowered to develop an execution strategy to collect digital device data by working with a variety of internal and external stakeholders, and a typical day will include: 

POSITION OBJECTIVES:

The Associate Director is responsible for developing an execution strategy to collect digital device data, e.g. generated by mobile phone apps and sensors, according to applicable regulations and internal standards in clinical studies.  Additional responsibilities include development of the infrastructure, processes and standards in conjunction with the assessment and management of external service providers, managing through change to achieve optimal results, drawing firm conclusions and providing recommendations for future studies.   

POSITION ACCOUNTABILITIES:

  • Provides feasibility assessment on devices and recommends an appropriate level of device verification and validation according to the fit-for-purpose principle; identifies risks and develops mitigation plans for device deployment in clinical trials
  • Drives technological evaluation of platforms and services; serves as an SME for audits /qualifications for digital means of data collection, e.g. wearable sensors and mobile device apps
  • Partners with Clinical Operations, Project Management, Procurement and Partnership office to select appropriate technology platforms and vendors for clinical study execution
  • Works with internal Takeda project teams, providing support for wearable technologies in the clinic, participates in project team meetings and serves as a liaison between the department and project teams 
  • Responsible for creating projects plans for digital device implementation, achieves functional alignment at the project team level, coordinates activities with external partners, including roles and responsibilities, budgets, timelines, tracking deliverables, following up on issue resolution and payments
  • Drives an internal process towards creating optimal process, standards and infrastructure for wearable data collection, data QC, review, analysis, interpretation and reporting
  • Manages through change, achieves optimal organizational alignment; authors internal functional SOPs
  • Co-authors technical and clinical study reports; provides input on regulated documents, such as study protocols, informed consent forms and patient questionnaires
  • Monitors emerging regulatory landscape and makes appropriate adjustments to the internal processes

EDUCATION, EXPERIENCE AND SKILLS:

  • MS with 10 years of relevant experience, with a minimum of 5 years of industry experience:
  • Relevant biotech, pharma, CRO or device industry experience is a must
  • Experience with technology evaluation, deployment and project management is required
  • Strong practical knowledge of applicable regulations and guidance
  • Experience with data management of complex, non-standards datasets is highly desirable
  • Ability to work collaboratively and influence others in a matrix setting
  • Strong organizational skills, attention to detail, ability to work independently and prioritize work
  • Excellent written and oral communication skills
  • Ability to work in a global, multi-cultural environment

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.

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Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0006835

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