Principal, Clinical Development

Lab Summary

Samsung Research America is seeking an experienced, highly motivated physician to join our Digital Health team as a Clinical Development Principal (Physician Digital Health Leader) and be a core part of a passionate team charged with developing, incubating, and launching innovative product concepts that will transform the future of healthcare. Digital Health is a multi-disciplinary agile team working on designing and developing innovative digital health products, services and solutions. The goal is to significantly empower consumers, patients, clinicians, and developers so they can leverage smartphones, wearables, medical devices, and IoTs in the health and wellness domain. Samsung’s unique advantage in the consumer electronics market and growing focus on Digital Health provides exciting technical challenges and rewarding career experience.

Position Summary

You will be responsible for digital health initiatives at the intersection of wellness and clinical care.  This will involve planning and developing future digital health products and platforms, including focusing on designing, developing and validating innovative product concepts and its consumer, clinical care and research applications, based on company’s digital health strategy and your insights from a clinical lens.

As a clinical leader, you will develop innovative product concepts, articulate the clinical vision and value proposition, define clinical product requirements, and play a critical role in influencing both internal and external stakeholders to develop and deliver products that create value for consumers, providers, researchers, and other stakeholders, and advance Samsung’s vision for Digital Health.

Position Responsibilities:

• Provide clinical leadership in developing novel digital health product concepts, incorporating latest technologies that provide unique value propositions
• Work closely with multi-disciplinary teams including engineers, designers, clinicians, clinical research and regulatory, providing clinical leadership
• Clinical and market analysis, competitive analysis, strategy development, health policy tracking and evaluation
• Identify, select and engage with partner companies and organizations (including payers, providers, technology companies) to advance strategy
• Support clinical strategy around new products, including digital biomarkers, devices, software, technologies, and solutions as well as regulatory processes
• Assess and specify relevant clinical validation design feasibility and complexity based on targeted claims
• Clinical study documentation including target product description, clinical study synopses and protocols
• Provide input on study endpoints and outcome measures, scientific/ clinical validity evaluations, gold standard instruments and questionnaires, and the relevant standards for evaluating medical devices
• Leverage clinical expertise, business experience and industry network in all areas
• Communicate team’s vision and solution value proposition at internal and external partner meetings and conferences
• Communicate effectively with a diverse group of internal and external partners around the globe

Position Requirements

• M.D/D.O or equivalent with 3+ years of clinical practice or equivalent combination of education, training, and experience
• Significant experience in digital health product innovation
• 12+ years combined clinical practice, clinical research, product innovation and digital health work experience.  Experience in cardiovascular, cardiometabolic, sleep, behavior change, digital therapeutics, or related areas are a plus
• Experience in designing, developing and validating digital health products, especially for consumers
• Experience in digital health products and solutions for consumers and healthcare settings
• Experience in digital health as applied to the decentralized clinical trials (DCT) space
• Experience with post-market and real-world evidence (RWE) studies
• Working knowledge of health policy, health data and privacy, healthcare reimbursement, and FDA regulatory processes
• Experience in areas such as digital biomarkers, digital diagnostics, digital therapeutics, AI in healthcare, clinical decision support, care-at-home, and age tech
• Knowledge of the digital health Industry trends, technologies, competitors, and trends
• Innovative thinker with ability to develop product concepts, clinical use cases and patient journey
• Experience in leading people and teams a plus
• Excellent written & oral communication skills, experienced in producing highly effective presentations to communicate with internal and external stakeholders
• Ability to anticipate, prepare f