Associate Director, Operations and Management, Digital Clinical Devices and Technologies
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.
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Associate Director, Operations and Management, Digital Clinical Devices and TechnologiesApply Now
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:
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.
- 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.
Job ID R0006835