Director, Clinical Affairs - Minimally Invasive Surgery Market

The role

The Director of Clinical Affairs manages the planning, directing, and execution of the minimally invasive surgery market portfolio. This role involves overseeing clinical trials for the CellFX nsPFA percutaneous electrode system to obtain new indications.

What you will do

• Provide operational expertise for planning, implementing, and executing clinical trials.
• Participate in discussions with cross functional product development teams.
• Contribute to clinical trial design including protocols, informed consent, and case report forms.
• Conduct literature reviews for clinical documents.
• Support training of internal staff, study investigators, and site personnel.
• Ensure procedures are properly performed by investigators, site personnel, and CROs.
• Oversee and manage key vendors such as CROs, Core Labs, and contractors.
• Ensure studies are on track for site initiation, patient recruitment, and enrollment.
• Manage clinical research reporting to regulatory authorities and IRB/Ethics.
• Support Regulatory Affairs during the submission process.

Required qualifications

• 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 conducting multi-center IDE clinical trials or pivotal clinical studies intended to support FDA approvals.
• Strong hands-on experience in directing and managing CROs, Core Labs, and Safety Committees (e.g., DSMB and CEC).
• Ability to function as both a project leader and a project team member.
• Proficient knowledge in devices that support ultrasound guided soft tissue ablation.
• Expert knowledge and comprehensive understanding of applicable GCP, ICH guidelines, FDA and applicable international regulations.
• 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.
• Meticulous attention to detail.
• Ability to analyze and interpret clinical data quickly and accurately.

Nice to have

• Experience in managing clinical trials using ablation devices to treat soft tissue tumors and/or nodules
• Experience in writing the clinical section of a 510k and/or PMA application to the FDA
• Management experience building and leading a team

Benefits

• A variety of health insurance plans
• 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
• Onsite gym
• Mindfulness classes

Before you apply

• Candidates must reside in the San Francisco Bay Area
• No relocation offered

About the company

Pulse Biosciences is a novel bioelectric medicine company committed to health innovation. The Company’s proprietary CellFX nsPFA technology delivers nanosecond pulses of electrical energy to non-thermally ablate cells.