Posted to MedZilla on 3/26/2017


Takeda Pharmaceuticals

US-MA, Director, Capabilities and Wearable Devices 1603167-MZ


 
 

Position Summary:

Director has the responsibility of evaluating, qualifying and testing wearable device technologies in clinical trials to augment data collection. This role is essential to provide new data streams and contribute to deep patient phenotyping.

Duties and Responsibilities:

Works with internal and external stakeholders to find optimal technological solutions and designs execution plans to address specific development program needs

Directs all aspects of wearable device work including identification of appropriate technologies, external partners, designing strategy and execution and partnering with other functional lines to have the experiments executed

Manages through change to adopt novel technological approaches and devices

Develops and maintains a network of external partners to facilitate device implementation, data collection and analysis using wearable technologies in clinical trials

Critically evaluates technologies, applications, identifies risks and develops mitigation plans for device deployment in clinical trials

Responsible for development of data analysis plans, collaborates to get the data analysis completed and interprets the results

Provides contributions to regulated documents including study protocols, informed consent forms and regulatory filings

Works with external partners to monitor the external eco system for emerging technologies and novel data sources, critically evaluates novel technologies and provides recommendations for implementation

Leads critical evaluation and prioritization of potential number partnerships and business opportunities

Facilitates driving an internal process towards creating an optimal infrastructure to accommodate wearable data collection and analysis

Partners with data management to establish data workflow process, appropriate internal infrastructure, assess applicability of data standards and facilitates data mapping to the databases

Writes reports, initiates and reviews internal and external documentation. Presents at external and internal scientific forums.

Qualifications

Qualifications:

Experience: MS with 10+ /PhD with 5+ years of industry experience

  • Relevant biotech, pharma or device industry experience is a must that includes device evaluation or drug development clinical trials
  • Clinical science background with proven record of designing and executing clinical experiments is highly desirable
  • Strong scientific and business acumen, strong analytical skills and ability to work independently
  • Ability to develop and maintain strong internal and external partnerships, manage by influence to drive the process with the end result in mind
  • Hands on experience with different types and formats of the data, working knowledge of data standards and regulatory requirements
  • Familiarity with biomedical device regulation including the FDA 510K process
  • Ability to adapt to quickly changing environment, multitask and prioritize multiple projects
  • Practical knowledge of GxP regulations and legal requirements
  • Ability to work collaboratively and influence others in a matrix setting
  • Strong organizational and project management skills, attention to detail
  • Excellent written and oral communication skills
  • Ability to work in a global, multi-cultural environment

    Schedule
    Full-time

    Please visit our website at takedajobs.com

     
     


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