Director, Clinical Affairs (Hybrid - Sunnyvale)

Job description

**About Ceribell** 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! **Position Overview**: The Director of Clinical Affairs will specifically focus on defining and executing the clinical evidence strategy supporting new products. This includes planning, designing and managing the execution of clinical trials aligned with company strategy, building and fostering relationships with key opinion leaders in the field (KOLs) and managing the preparation and dissemination of evidence through conferences, publications and marketing materials. This leader will ensure all clinical activities are aligned with business goals, scientifically sound, ethically conducted, and fully compliant with global regulatory standards. **What you'll do:** **Clinical Strategy & Leadership** - 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) **Protocol & Study Design** - 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. **Data & Regulatory Submissions** - 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. **Leadership & Compliance** - 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 **What We're Looking For:** - 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). Compensation Range $208,000—$256,000 USD A candidate’s final salary offer will be based on their skills, education, work location and experience, and thus it may differ from the posted range. Compensation may also include bonuses consistent with Ceribell’s corporate compensation plan. Note, the above description is not all-encompassing and Ceribell reserves the right to change or modify job duties and assignments at any time. **In addition to your base compensation, Ceribell offers eligible employees the following:** - Performance-based incentive compensation (varies by role) - Equity opportunities - 100% Employer paid Health Benefits for Employees - 50% - 70% Employer paid Health, Dental & Vision for dependents (depending on plan selection) - 100% paid Life and Long-Term Disability Insurance - 401(k) with a generous company match - Employee Stock Purchase Plan (ESPP) with a discount - Monthly cell phone stipend - Flexible paid time off - 13 Paid Holidays + 3 Company Wellness Days - Excellent parental leave policy - Fantastic culture with tremendous career advancement opportunities - Joining a mission-minded organization! **Application Deadline:** Ongoing **Other Job Details**Ceribell reports transfers of value to health care providers (HCPs) as required by federal and state transparency laws. These laws and implementing regulations require Ceribell to provide government agencies with HCPs’ names, addresses and the type of payments or other value received, generally for public disclosure. If you are an HCP and we pay or reimburse your recruiting expenses as a result of interviewing with Ceribell, your name, address and the amount of payments made may be reported to the government. **Equal Opportunity Employer**Ceribell is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity or expression, national origin, age, marital status, disability, veteran status or any other characteristic protected by law. Ceribell complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Ceribell is an E-Verify employer. Any applicant with a disability who requires an accommodation during the application process should contact [talent@ceribell.com](mailto:talent@ceribell.com) to request reasonable accommodation. **Privacy Statement**For information on how Ceribell processes personal data of job applicants, please review our [Privacy Policy](https://ceribell.com/privacy-policy/). **Compliance Disclaimer**If you believe this job posting is non-compliant, please submit a report to [legal@ceribell.com](mailto:legal@ceribell.com). Please note that we will not respond to inquiries unrelated to job posting compliance.