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.
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.
- Builds and develops a high performing team.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- MS/PhD with Degree concentration in a quantitative, analytic, engineering or life science discipline required.
- 10+ / years of industry experience in medical device development or management
- 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