DeepsonBio USA – Chief Clinical Officer (CCO)

DeepsonBio USA – Chief Clinical Officer (CCO)  Location: United States (The specific location is flexible / Remote with travel as needed)  Company: DeepsonBio https://deepsonbio.com/https://www.linkedin.com/company/deepsonbio/ Industry: Medical Devices / Neuroscience / Therapeutic Ultrasound About DeepsonBio:DeepsonBio is a Korea-based medical device company pioneering non-invasive ultrasound neuromodulation technology for the treatment of Alzheimer’s disease and other neurological disorders.With successful preclinical and early clinical studies in Korea, we are now establishing our U.S. subsidiary to lead FDA clinical trials, regulatory approvals, and commercialization of our innovative brain therapy device. Position Overview:We are seeking an experienced and visionary Chief Clinical Officer (CCO) to lead DeepsonBio’s U.S. clinical trial operations.This position will play a critical role in designing, initiating, and managing U.S.-based clinical trials, coordinating with CROs and clinical sites (academic hospitals and research centers), and driving FDA regulatory strategy. Key Responsibilities:- Lead all U.S. clinical operations, including site selection, CRO management, and protocol execution.- Oversee regulatory strategy and submissions (e.g., IDE, 510(k), De Novo).- Establish relationships with key investigators, hospitals, and clinical institutions.- Coordinate with the Korean headquarters on data management, documentation, and reporting.- Ensure compliance with GCP, FDA, and international regulatory standards.- Contribute to overall clinical and product development strategy as part of the executive team. Qualifications:- 10+ years of experience in clinical operations, regulatory affairs, or medical device development (CRO or medtech background preferred).- Proven track record in managing multi-site clinical trials in the U.S.- Strong understanding of FDA regulatory pathways for Class II or Class III medical devices.- Excellent communication and leadership skills across cross-cultural teams.- Fluency in English required; proficiency in Korean or prior experience working with Korean teams is a plus.- Advanced degree in life sciences, biomedical engineering, or related field (PhD, MD, or equivalent preferred). Why Join Us:- Opportunity to lead the U.S. clinical and regulatory roadmap of a breakthrough neuromodulation technology.- Collaborative international environment bridging top-tier research teams in the U.S. and Korea.- Competitive compensation with equity participation available.- Mission-driven team dedicated to improving brain health and quality of life for patients.How to Apply:Please send your CV and a brief statement of interest to DeepsonBio's linkedin account.