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Full-Time

Director – Clinical Operations

Confirmed live in the last 24 hours

Ceribell

Ceribell

201-500 employees

EEG devices for monitoring brain activity

Biotechnology
Healthcare

Compensation Overview

$220k - $235kAnnually

+ Bonus + Equity

Senior, Expert

Sunnyvale, CA, USA

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary
Required Skills
Communications
Management
Requirements
  • Advanced degree (preferred) in a relevant scientific or medical field (e.g., MD, PhD, PharmD).
  • Minimum of 8-10 years of experience in clinical operations within the medical device or pharmaceutical industry.
  • Demonstrated experience in protocol development, site management, IRB processes, patient enrollment, and data management.
  • Strong understanding of regulatory requirements and Good Clinical Practice (GCP).
  • Excellent leadership, communication, and interpersonal skills.
  • Ability to manage multiple projects simultaneously and meet deadlines.
  • Strategic thinker with the ability to contribute to clinical and regulatory planning.
Responsibilities
  • Lead the development and preparation of clinical trial protocols, informed consent forms, and other essential study documents.
  • Ensure that all study materials align with regulatory requirements and company standards.
  • Identify, evaluate, and qualify clinical trial sites.
  • Build and maintain strong relationships with site investigators and staff.
  • Manage and oversee Institutional Review Board (IRB) submissions and approvals.
  • Ensure all studies adhere to ethical standards and regulatory guidelines.
  • Develop and implement strategies for patient recruitment and retention.
  • Monitor enrollment progress and address any challenges to ensure study timelines are met.
  • Oversee data collection, monitoring, and management activities to ensure data integrity and compliance.
  • Collaborate with data management teams to ensure accurate and timely reporting of study data.
  • Ensure all clinical operations comply with applicable regulatory requirements, Good Clinical Practice (GCP), and company policies.
  • Conduct regular quality checks and audits to maintain high standards of clinical practice.
  • Provide input on clinical and regulatory strategy to support product development and commercialization efforts.
  • Collaborate with cross-functional teams to align clinical operations with overall business objectives.

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. Unlike some other EEG devices, Ceribell's products do not provide diagnostic conclusions or automated alerts; instead, they serve as a tool for data collection, particularly in urgent situations like Nonconvulsive Status Epilepticus (NCSE), where timely intervention is crucial. Ceribell differentiates itself by focusing on 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.

Company Stage

Series C

Total Funding

$172M

Headquarters

Mountain View, California

Founded

2014

Growth & Insights
Headcount

6 month growth

8%

1 year growth

23%

2 year growth

76%
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Simplify's Take

What believers are saying

  • Ceribell's recent $102 million equity investment and $50 million financing round indicate strong financial backing for expansion and product development.
  • The appointment of experienced leaders like Sean Manni and Joshua Copp positions the company for strategic growth and operational excellence.
  • Recognition by Fast Company as one of the World's Most Innovative Companies highlights Ceribell's industry impact and potential for continued innovation.

What critics are saying

  • The reliance on healthcare providers to interpret EEG data may limit the device's adoption in settings with less specialized staff.
  • The competitive landscape in medical devices and AI-powered diagnostics could pose challenges to Ceribell's market share.

What makes Ceribell unique

  • Ceribell's AI-powered point-of-care EEG system is a first-of-its-kind technology, setting it apart from traditional EEG devices.
  • The company's focus on rapid, easy-to-use brain monitoring solutions for time-critical conditions like NCSE provides a unique value proposition.
  • FDA Breakthrough Device Designation for delirium detection further validates Ceribell's innovative approach in neurodiagnostics.