Clinical Research Director jobs in San Jose, CA

Lab Summary:

Our mission is to empower people to live healthier lives by leveraging our wearables, smartphones, medical devices, AI, and health services.  We research, develop, and commercialize innovative digital health products and solutions by bringing together the full capabilities of our team, including product strategy and management, clinical expertise, partnerships, UI/UX design, usability research, clinical research and validation, software development, AI / Gen AI, and regulatory. Millions of Samsung users’ lives around the world have been touched by our products, including the Samsung HeartWise for cardiac rehabilitation and the Samsung ECG Monitor App. Samsung’s unique advantage in the consumer electronics market and growing focus on Digital Health and AI / Gen AI provides exciting technical challenges and rewarding career experience.  Join us! 

 Position Summary:

Samsung Research America seeks a Director of Clinical Research, Digital Health (Co-Innovation, Sponsored Research Program) who will be responsible for managing our expanding co-innovation / sponsored research program with leading universities and academic medical centers. These partnered research programs are focused on bringing together the unique capabilities of Samsung and leading universities and academic centers to co-develop innovative research and cutting-edge digital health products at the intersection of consumer wellness and clinical care.

This position will work closely with teams and leaders internally to define our sponsored research strategy, prioritize areas of interest, build relationships with leading universities and academic medical centers, and identify the right partners whose capabilities and experience will lead to success of the program. A key aspect of the work will involve reviewing proposals, providing input and feedback on product concepts, clinical study design, protocols, data collection approaches, statistical analysis, and development of algorithms, biomarkers, apps or other products.

In addition to developing new partnerships, this Director will manage the current portfolio of sponsored research projects to ensure strong, ongoing collaboration and partnerships, excellence in research, high productivity, timely completion of milestones, and tangible outputs and deliverables. The Director, Clinical Research will oversee all aspects of the program including technical, IP, clinical, publications, project management, and budgets.

 Position Responsibilities:

• Lead our sponsored research program and university partnerships to ensure that our co-innovation program leads to strong research and outcomes (product, data, algorithms, IP).
• Bring together teams across Samsung and partnered centers including researchers, engineers, designers, clinicians, AI/ML experts, regulatory experts to ensure that the right teams are engaged to deliver on goals.
• Identify, select, and develop partnerships with the right universities whose capabilities are aligned with program goals.
• Develop and implement a process to identify partners, review proposals, and select partner universities.
• Develop and implement a strong program management system to manage multiple programs effectively, ensuring timely progress and delivery of project milestones and deliverables.
• Provide timely reviews and input to partners in areas such as clinical study design, algorithm development, and research involving our wearables, devices, and apps.
• Ensure research excellence and scientific publications and presentations with appropriate joint review with partners.

 Required Skills:

• Ph.D. / D.O. or Ph.D. in a technical/engineering field or health or biological sciences or equivalent combination of education, training, and experience.
• 12 years of clinical research experience, ideally in digital health, and preferably with a combination of experience across academic, clinical, and industry settings.
• Strong capabilities and experience in managing partnered research programs and projects, including relationship development, negotiating agreements, managing IP, and program management.
• Extensive knowledge and experience in leading all aspects of clinical research, including study design, protocol development, statistical analysis, publications, as well as clinical operations.
• Experience in implementing wearables, health devices, and apps within clinical studies.
• Experience in clinical research and product innovation in digital health, especially in cardiovascular, diabetes, sleep, and/or behavior science areas are a plus.
• Working knowledge of regulations and policies relevant to human subjects research (e.g. GCP, HIPAA, etc) and familiarity with data and interoperability standards (e.g., C-CDA, TEFCA, FHIR).
• Working knowledge of the health care systems, including care delivery within health systems.
• Strong experience in developing and running successful clinical research programs.