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, 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, Digital Clinical Devices and Technologies, you will be empowered to evaluate, qualify and test 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. A typical day will include:
- Works with internal and external stakeholders to find optimal technological solutions and designs execution plans to address specific development program needs
- Manages through change to adopt novel technological approaches and devices, including mobile device apps and sensors
- Designs and executes experiments for wearable data collection working with drug development project teams
- 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
- Monitors the external eco system for emerging technologies and novel data sources
- Facilitates driving an internal process towards creating an optimal infrastructure to accommodate wearable data collection and analysis
EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Experience: MS with 10+ /PhD with 5+ years of industry experience
- Relevant biotech/ pharma, device industry or CRO experience is a must
- 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
- 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
- Routine demands of an office based environment.
- Infrequent travel may be required as a part of this role.
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.