VP/SVP, Clinical Affairs

Sunnyvale, California, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Technology, HealthcareIndustries

Requirements

The ideal candidate will possess 10+ years of management experience leading a clinical group, including clinical/medical affairs and clinical operations, with a strong preference for experience as a VP/SVP/CMO in an early-stage or growth-stage medical technology or therapeutics company. They should have intimate understanding of population health and value-based care delivery models, demonstrated experience managing retrospective studies, and success working with external constituents on reducing cost of care and improving outcomes. Furthermore, the candidate must have thorough knowledge of relevant FDA regulations and guidelines, including those of the EU (EMA/NHS) and other health authorities, along with experience in interactions with FDA personnel and other health authorities, and a strong understanding of clinical research concepts, practices, and GCP and ICH Guidelines.

Responsibilities

This role will direct the development of clinical strategies and plans to integrate Ceribell’s technologies into the standard of care across the neurology and acute care settings, provide executive leadership to the Clinical Affairs organization, orchestrate and manage clinical elements of regulatory strategy, lead a cross-functional team to deliver project plans, build on Ceribell’s research and publication strategy, and manage an Advisory/KOL strategy to engage the provider community. The VP/SVP, Clinical Affairs will also be responsible for building and maintaining strong relationships with internal and external scientific, technical, and organizational leaders, representing Ceribell at scientific conferences and with regulatory agencies, and ensuring all internal processes comply with regulatory standards.

Skills

Clinical Strategy

Clinical Programs

Regulatory Strategy

Regulatory Authorities

Project Management

Leadership

Research

Publication Strategy

Neurology

Acute Care

Ceribell

EEG devices for monitoring brain activity

About Ceribell

Ceribell focuses on developing medical devices that utilize electroencephalogram (EEG) technology to monitor brain activity. Their main product, the Ceribell EEG Headband and Recorder, is designed for use by trained healthcare providers in professional settings. These devices help gather important data about a patient's brain activity, which healthcare professionals can analyze to make informed treatment decisions, especially in urgent situations like Nonconvulsive Status Epilepticus (NCSE), where timely intervention is crucial. Unlike some other EEG devices, Ceribell's products do not provide diagnostic conclusions or automated alerts; they serve purely as data collection tools. Ceribell differentiates itself by emphasizing the speed and efficiency of data gathering, which is vital in critical care scenarios. The company's goal is to enhance the ability of healthcare providers to monitor and respond to neurological conditions effectively.

Mountain View, CaliforniaHeadquarters

2014Year Founded

$146.9MTotal Funding

SERIES_CCompany Stage

HealthcareIndustries

201-500Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Unlimited Paid Time Off

Paid Holidays

Parental Leave

Annual Bonus Opportunity

Company Equity

Phone/Internet Stipend

Risks

Emerging AI-powered EEG technologies increase competition, threatening Ceribell's market share.

Regulatory scrutiny on AI medical devices could lead to compliance costs and delays.

Scaling production post-IPO may cause supply chain bottlenecks, affecting delivery timelines.

Differentiation

Ceribell's EEG system is FDA cleared and requires no specialist interpreter.

The Brain Stethoscope function converts brainwaves to sound for easy seizure detection.

Ceribell's EEG system can be set up in 6 minutes by any healthcare provider.

Upsides

AI integration enhances Ceribell's diagnostic capabilities, providing a competitive market edge.

Growing EEG market demand due to rising neurological disorders benefits Ceribell's product sales.

Point-of-care testing trend supports adoption of Ceribell's portable EEG system.

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