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Salary: USD 208,000 - 256,000 / annual
Ceribell is a medical technology company transforming the diagnosis and management of serious neurological conditions through its novel point-of-care EEG platform. The Director of Clinical Affairs will lead the clinical evidence strategy for new and existing products, ensuring alignment with regulatory requirements and commercial goals.
Key responsibilities include developing and executing clinical strategy for current and future products in alignment with FDA, EMA, and other regulatory requirements. You will lead the planning, design, and execution of clinical trials (feasibility, pivotal, post-market, registries) that drive product validation and market expansion. You'll serve as the primary clinical interface between Regulatory Affairs, R&D, Go-to-Market, and Commercial teams, translating business needs into scientifically valid clinical plans.
You will oversee protocol design and authoring, ensuring appropriate endpoints, statistical power, and rigorous methodology compliant with Good Clinical Practice and ethical guidelines. You'll lead the selection and management of Key Opinion Leaders (KOLs) to advise on study design and clinical data interpretation, represent the company at conferences, and manage relationships with key stakeholders.
Responsibilities also include leading analysis, interpretation, and reporting of clinical data for presentations, abstracts, and publications. You will own the clinical sections of regulatory submissions (PMA, 510(k), CE Mark) and defend clinical data during regulatory discussions and audits. You'll establish and maintain robust Clinical Quality Systems and SOPs, manage study budgets and resource allocation, and handle multiple projects simultaneously in a fast-paced environment.
Required qualifications: Bachelor's degree in life science, engineering, or related discipline (advanced degree such as Ph.D., M.D., Pharm.D., or Master's highly preferred). Minimum 8+ years of progressive experience in Clinical Research/Affairs within the medical device industry. Proven track record designing, executing, and reporting pivotal randomized clinical trials. Deep working knowledge of FDA regulations (CFR Title 21), ICH-GCP, and ISO 14155.
