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 a Director, Sc 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 the Director, Scientific Liaison, 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:
- Serves as a liaison with Therapeutic Area Units (TAUs), serves as a subject matter expert on digital clinical devices and technologies
- Partners with clinical scientists to identify unmet needs and disease/ health conditions to be addressed with technological applications, and formulates hypothesis to be tested in clinical studies; articulates value of technological applications and ROI
- Critically evaluates digital technologies and applications to find optimal solutions; provides recommendations for intended use, works with digital device operations to design execution plans to address specific development program needs
- Designs experiments and facilitates the execution working with digital technology operations
- Develops and maintains a network of external partnerships
- Monitors the external eco system for emerging technologies, novel data sources and technology services
- Drives technological innovation, identifies and establishes academic collaborations, authors peer-review publications
- Drives the creation of data analysis plans in collaboration with Biostatistics and Computational Biology groups, actively participates in the data analysis process, critically evaluated analysis results, interprets the results and recommends technology use for the future studies
- Co-authors technical and clinical study reports
- Provides contributions to regulated documents including study protocols, informed consent forms and regulatory filings
EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:
- MS with 15+ /PhD with 8+ 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 a must
- Strong scientific and business acumen, strong analytical skills and ability to work independently
- Familiarity with biomedical device regulations and guidance, including the FDA 510K process
- Ability to adapt to quickly changing environment, multitask and prioritize multiple projects
- Strong publication records
- Experience with developing analysis plans for emerging technologies, data review and interpretation
- 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.