Senior Manager of Clinical Affairs

About the Company

Neptune Medical is an innovative, venture capital funded medical device startup headquartered in Burlingame, CA. The team is building Triton Robotic Endoscopy, a fully flexible medical robot designed to disrupt flexible endoscopy and set new standards in clinical outcomes.

Responsibilities

• Lead the development and execution of the overall clinical strategy aligned with company and regulatory objectives
• Oversee the design, initiation, execution, monitoring, and closeout of clinical studies
• Provide strategic oversight of CROs, vendors, investigators, and internal teams
• Lead the development and review of key clinical documents including protocols, investigator brochures, and clinical study reports
• Facilitate regulatory submissions and interact with regulatory agencies to support product approvals
• Ensure clinical activities comply with GCP, FDA, ISO, and applicable international regulations
• Provide strategic oversight of clinical trial budgets, timelines, and resource planning

Requirements

• B.S. in Biomedical Engineering, Life Sciences or similar
• 7-10+ years of progressive experience in medical device clinical research
• Experience leading complex clinical studies and developing clinical strategies for regulatory submissions
• Strong knowledge of GCP, FDA, ISO standards, and international regulations
• Proven ability to lead cross-functional teams
• Excellent written and verbal communication skills
• Ability to travel up to 20% domestically and internationally

Preferred Qualifications

• Experience in medical robotics
• Master’s degree or higher in Biomedical Engineering, Life Sciences, or a related discipline
• Experience or knowledge of the GI/endoscopy space