Director, Clinical Affairs - Minimally Invasive Surgery Market

Pulse Biosciences•Hayward, CA

10d•Onsite

About The Position

The Director of Clinical Affairs for the Minimally Invasive Surgery Market (e.g., thyroid) is responsible for planning, directing, and executing the minimally invasive surgery market portfolio. The role requires current knowledge of applicable U.S. and international regulations and guidance for conducting clinical trials in compliance with sponsored protocols, Good Clinical Practices (GCPs), and Standard Operating Procedures (SOPs), as well as in-depth product and clinical knowledge of indications. The Director brings strong leadership, problem-solving, and decision-making abilities. The position provides operational expertise for clinical trials involving the CellFX nsPFA percutaneous electrode system, supporting new or specific indications in accordance with project timelines, budgets, and quality standards. It contributes to trial design and documentation, coordinates cross-functional clinical readiness, supports trial training and execution, oversees vendors and study progress, addresses study issues, and manages clinical reporting and expenses. The Director also supports regulatory submissions and ensures clinical results are clearly interpreted and documented. The role includes hiring, managing, and developing internal Clinical Affairs staff and contractors as needed. The position is located in Hayward, California, and candidates must reside in the San Francisco Bay Area. Relocation is not offered. Travel may be up to 30%, including overnight domestic and/or international travel. The role may require lifting 10–15 pounds.

Requirements

BS, BA, BSN, RN, or higher degree in Life Sciences or a related discipline.
At least 10 years of progressive industry experience with a medical device company.
At least 5 years of 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 directing and managing CROs, Core Labs, and Safety Committees such as DSMBs and CECs.
Ability to function as both a project leader and a project team member.
Proficient knowledge of devices that support ultrasound-guided soft tissue ablation.
Expert knowledge and comprehensive understanding of applicable GCP, ICH guidelines, and FDA and applicable international regulations.
Expert knowledge and comprehensive understanding of U.S. and European current practice guidelines on percutaneous soft tissue ablation for treatment of benign and cancerous nodules.
Knowledge of electronic data capture systems and web-based clinical trial management tools.
Meticulous attention to detail and ability to analyze and interpret clinical data quickly and accurately.
Excellent interpersonal, written, verbal communication, and organizational skills.
Ability to effectively manage time and resources and multitask.
Ability and willingness to work hands-on while also thinking strategically.
Ability to work as a team member, multitask, and adapt flexibly to changing priorities and requirements in a dynamic, fast-growing company.
Strong program management and critical-thinking skills.
High-level computer skills, including MS Word, Excel, and 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.
Must reside in the San Francisco Bay Area.

Nice To Haves

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

Responsibilities

Provide operational expertise in planning, implementing, and executing clinical trials for new or specific indications associated with the CellFX nsPFA percutaneous electrode system, in accordance with timelines, budgets, and quality standards.
Participate regularly in discussions with cross-functional product development teams and create documents required for clinical readiness.
Contribute to clinical trial design and development, including protocols, informed consent forms, case report forms or procedural worksheets, questionnaires, trial master files, timelines, milestones, project plans, and deliverables in conjunction with the research team.
Conduct literature reviews for clinical documents, including Reports of Prior Investigation (ROPI) and Investigator Brochures (IB).
Support training of internal staff, study investigators, and other site personnel on proper trial conduct and product performance specifications.
Ensure investigators, site personnel, field team members, and CROs properly perform procedures and techniques to mitigate study-device risks.
Oversee and manage key vendors, including CROs, Core Labs, and contractors.
Monitor site initiation, patient recruitment, and enrollment; take corrective action when needed to address issues.
Ensure studies are conducted with high quality and in accordance with procedures, protocols, and investigational plans.
Attend surgical procedures for training purposes as needed.
Problem-solve clinical study issues and define solution matrices.
Manage clinical research reporting, including reporting to regulatory authorities and clinical research oversight entities such as IRBs and Ethics Committees, as necessary.
Support Regulatory Affairs during the submission process.
Ensure clinical results are interpreted and documented clearly and concisely for regulatory submissions and publications.
Review, track, and approve clinical trial expenses and submit monthly clinical trial accruals to accounting.
Develop and manage clinical project budgets and adhere to company financial goals, including coordinating accrual expenses for minimally invasive surgical studies with accounting.
Hire, manage, and develop the internal Clinical Affairs team and contractors as needed; set objectives and performance goals and empower the team to deliver on company strategic priorities.