Magic Leap’s mission is to harmonize people and technology to create a better, more unified world. Magic Leap is a team of creatives and technologists building a personal, spatial computing platform that seamlessly blends the digital and physical worlds. Magic Leap’s healthcare team is changing the world of consumer well-being, diagnostics, and digital therapeutics, and is looking to expand its team.
The Clinical Data Lead serves as the person responsible for the coordination of clinical research activities within the Healthcare team primarily for projects involving healthcare data. The ideal candidate brings a wealth of know-how in the execution of biomedical and clinical research and the strong desire to drive the application of cutting-edge technologies in our pursuit for better health and well-being of all of us humans. The Clinical Data Lead will be responsible for the entire cycle of research execution, from basic exploratory research, proof of concepts, and preliminary data analysis, to the coordination of well-designed and statistically significant clinical studies. As the clinical expert, the Clinical Data Lead will also be ultimately responsible to provide the team with advice and guidance regarding all pertinent regulations, norms, and standards applicable to clinical trials of the product and to the clinical activities performed with it.
- Investigate clinical applicability of Magic Leap technologies in the health and wellness field
- Perform exploratory clinical research and literature review to develop healthcare applications
- Research clinical data extraction and classification for translational medicine applications
- Analyze sensor datasets to define or determine algorithms to enable clinical predictions and insights
- Create and document technical and scientific findings and communicate them to appropriate teams
- Execute preliminary studies and data analysis to determine feasibility of clinical projects
- Plan and coordinate clinical research through internal resources and in partnership with external entities and institutions
- Prepare and submit clinical trial documentation to local IRBs/ethics committees and respective regulatory authority as needed (FDA, EU). Will work closely with regulatory team to achieve this.
- Coordinate with software teams in the development of and validation of clinically sound algorithms and methods
- Coordinate with data teams for the proper and secure storage and analysis of data collected through research
- Ensure that all activities are performed to clinical standards and in compliance with all regulations including FDA/HIPAA, EU/GDPR
- Ensure that clinical studies are performed ethically and abiding by all norms and principles of human subjects research
- 7+ years of experience leading clinical research in both regulated (medical device) and non-regulated (general wellness) fields
- Expertise in exploratory research, literature review, and basic investigation
- Experience with administrative and logistical process of clinical study execution (i.e., preparing, submitting, gaining approval, execution, results documentation related to clinical trials)
- Expertise in biostatistics and data analysis, including use of statistical computing and scripting tools such as R, Matlab, and Python
- Strong knowledge of regulatory landscape for medical technologies, devices, software, and data, including FDA/HIPAA, EU/GDPR
- Ability to apply problem solving techniques to resolve complex issues at investigator sites and within study, and apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical research study at an investigator site
- Ability to employ critical thinking to determine the cause and appropriate solution in the identification of issues
- Strong organizational, documentation, and interpersonal skills as well as a willingness to work within a team-oriented environment
- Experience in the application of wearable and mobile technologies in the healthcare domain preferred
- Familiarity with cloud technologies and systems, including distributed and NoSQL databases, and distributed file systems such as Hadoop preferred
- Experience in the execution of data-driven research preferred
- Willingness to travel within USA and Europe
- Advanced degree in medical, nursing, biological sciences, public health, biostatistics, biomedical engineering or similar field
- All your information will be kept confidential according to Equal Employment Opportunities guidelines.