Director, Clinical Affairs — Minimally Invasive Surgery

Pulse Biosciences, Inc.; Hayward (CA); On-site; USD 190,000 - 250,000; Full time

Job summary

Pulse Biosciences, Inc. is seeking a Director of Clinical Affairs for the Minimally Invasive Surgery Market in Hayward, CA. You will plan and execute clinical trials for the CellFX nsPFA technology, ensuring regulatory compliance and timely delivery of study milestones.

You will lead cross-functional teams, manage CROs and vendors, and support FDA submissions while maintaining rigorous standards in GCP and trial management. This is a senior, on-site role based in the San Francisco Bay Area.

Qualifications

• BS/BA/BSN or RN or higher in life sciences.
• 10+ years of progressive industry experience with a medical device company.
• 5+ years clinical trial management experience with class II and III medical devices.
• Experience with ablation devices to treat soft tissue nodules is a plus.
• Experience in multi-center IDE trials or pivotal studies for FDA approvals.
• Experience writing clinical sections of 510k/PMAs for FDA.
• Experience managing CROs, Core Labs, and Safety Committees.
• Strong leadership and program management skills.
• Proficiency in MS Word/Excel/PowerPoint.

Responsibilities

• Plan, direct, and execute the clinical trials program for the CellFX nsPFA system.
• Collaborate with cross-functional teams on trial readiness and protocol development.
• Manage vendor relationships and trial budgets; ensure regulatory compliance.
• Oversee site initiation, recruitment, data capture, and trial reporting to authorities.
• Maintain high quality documentation per GCP, SOPs, and regulatory requirements.
• Provide training and guidance to staff, investigators, and CROs.

Skills

Program management

CRO management

Communication skills

Leadership

Regulatory knowledge

Education

Life sciences degree

Tools

EDC systems

Clinical trial management tools

Job description

Pulse Biosciences, Inc. is seeking a Director of Clinical Affairs for the Minimally Invasive Surgery Market in Hayward, CA. You will plan and execute clinical trials for the CellFX nsPFA technology, ensuring regulatory compliance and timely delivery of study milestones.

You will lead cross-functional teams, manage CROs and vendors, and support FDA submissions while maintaining rigorous standards in GCP and trial management. This is a senior, on-site role based in the San Francisco Bay Area.