Director, Clinical Affairs – Minimally Invasive Surgery Market

Pulse Biosciences, Inc.

. Plan, direct, and execute the minimally invasive surgery market portfolio .

Posted 10/15/2026full-timeHayward • California • United StatesLead💰 $190,000 - $250,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Plan, direct, and execute the minimally invasive surgery market portfolio
Provide operational expertise for planning, implementation, and execution of clinical trials for the CellFX nsPFA percutaneous electrode system
Participate in cross-functional product development discussions and create documents required for clinical readiness
Contribute to clinical trial design, including protocols, informed consent forms, case report forms, procedural worksheets, questionnaires, trial master files, timelines, milestones, and project plans/deliverables
Conduct literature reviews for clinical documents such as ROPI and Investigator Brochure
Support training of internal staff, study investigators, and site personnel
Ensure procedures and techniques are properly performed by investigators, site personnel, field team members, and CROs
Oversee and manage CROs, Core Labs, and contractors
Track site initiation, patient recruitment, and enrollment; take corrective actions as needed
Ensure studies meet procedures, protocols, investigational plans, quality standards, and Good Clinical Practices
Attend surgical procedures for training purposes as needed
Resolve clinical study issues and define solution matrices
Manage clinical research reporting to regulatory authorities and IRB/Ethics oversight entities
Support Regulatory Affairs during submissions
Ensure clinical results are clearly interpreted and documented for regulatory submissions and publications
Review, track, and approve clinical trial expenses; submit monthly accruals to accounting
Develop and manage clinical project budgets and coordinate accrual expenses with accounting
Hire, manage, and develop the Clinical Affairs internal team and contractors; set objectives and performance goals

Requirements

What you’ll need

BS, BA, BSN or RN or higher degree in the Life Sciences or related disciplines
10+ years of progressive industry experience with a medical device company
5+ years clinical trial management experience with class II and class III medical devices
Experience in managing clinical trials using ablation devices to treat soft tissue tumors and/or nodules is a plus
Experience in conducting multi-center IDE clinical trials or pivotal clinical studies intended to support FDA approvals
Experience in writing the clinical section of a 510k and/or PMA application to the FDA is a plus
Strong hands-on experience in directing and managing CROs, Core Labs, and Safety Committees (e.g., DSMB and CEC)
Management experience building and leading a team is a plus
Demonstrate ability to function as both a project leader and a project team member
Proficient knowledge in devices that support ultrasound guided soft tissue ablation
Demonstrate expert knowledge and comprehensive understanding of applicable GCP, ICH guidelines & FDA and applicable international regulations
Demonstrate expert knowledge and comprehensive understanding of US and European current practice guidelines on percutaneous soft tissue ablation for the treatment of benign and cancerous nodules
Knowledge of electronic data capture systems and web-based clinical trial management tools
Ability to analyze and interpret clinical data quickly and accurately
Excellent interpersonal, written, verbal communication & organizational skills
Ability to effectively manage time, manage resources and multi-task
Ability and willingness to both "roll up sleeves" and think strategically
Ability to work as a team member, multi-task and be very flexible to adapt to changing work priorities and requirements
Strong program management and critical thinking skills
High level computer skills required (e.g. MS Word, Excel, PowerPoint)
Ability to travel up to 30% of the time; overnight domestic and/or international travel may be required
Ability to lift 10–15 pounds
Candidates must reside in the San Francisco Bay Area
No relocation offered

Benefits

Comp & perks

A variety of health insurance plans and supplemental insurance options
401k retirement savings plan
Stock options awards
Employee Stock Purchase Plan (ESPP)
Paid time off
Paid holidays
Flexible work schedule
Wellness program, including onsite gym and mindfulness classes
Professional and personal growth and development opportunities