Director, Clinical Affairs (Hybrid - Sunnyvale)

Ceribell is a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions. The Ceribell System is a novel, point-of-care electroencephalography (“EEG”) platform specifically designed to address the unmet needs of patients in the acute care setting, and is being used in hundreds of community hospitals, large academic facilities and major IDN's across the country. Our entire team is driven by a shared commitment to transforming the landscape of critical care through our rapid seizure detection technology, come join the movement!

• Develop and drive the clinical strategy for current and future products, ensuring alignment with regulatory requirements (e.g., FDA, EMA) and commercial goals.
• Lead the planning, design and execution of clinical trials that drive product validation, adoption and market expansion. 
• Serve as the primary clinical interface with Regulatory Affairs, R&D, Go-to-Market and Commercial teams to translate business needs into scientifically valid clinical plans.
• Lead the selection and management of Key Opinion Leaders (KOLs) to advise on study design, clinical data interpretation and long-term strategies.
• Ability to manage multiple projects simultaneously and to solve problems proactively in a fast-paced environment where priorities can shift quickly.
• Represent the company at conferences and be the primary point of contact for key opinion leaders (KOLs)

• Oversee the design, authoring, and finalization of clinical protocols (e.g., feasibility, pivotal, post-market, registries) to ensure appropriate endpoints, statistical power, and rigorous methodology.
• Provide medical and scientific input on marketing  and patient-facing materials.
• Ensure all clinical protocols meet Good Clinical Practice (GCP) and all relevant ethical guidelines.

• Lead the analysis, interpretation, and final reporting of clinical data, culminating in presentations, abstracts and publications .
• Own the clinical sections of regulatory submissions (e.g., PMA, 510(k), CE Mark), defending the clinical data and strategy during regulatory body discussions and audits.

• Establish and maintain robust Clinical Quality Systems (CQS) and Standard Operating Procedures (SOPs) for clinical research activities.
• Manage the budget and resource allocation for clinical studies.
• Other responsibilities as assigned by your Manager/Supervisor

• Education: Bachelor’s degree in a life science, engineering, or related discipline. An advanced degree (Ph.D., M.D., Pharm.D., or Master’s) is highly preferred.
• Director: Minimum of 8+ years of progressive experience in Clinical Research/Affairs within the medical device industry.
• Technical Proficiency: Proven track record in designing, executing, and reporting pivotal, randomized clinical trials for medical devices.
• Regulatory Knowledge: Deep, working knowledge of FDA regulations (CFR Title 21), ICH-GCP, and ISO 14155 (Clinical investigation of medical devices).