Director, Clinical Affairs - Minimally Invasive Surgery Market

Pulse Biosciences•Hayward, CA

5h•$190,000 - $250,000•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 regulatory guidance for clinical trials, and ensuring compliance with sponsored protocols, Good Clinical Practices (GCPs), and Standard Operating Procedures (SOPs). It also requires in-depth product and clinical knowledge of the relevant indications, along with strong leadership, problem-solving, and decision-making abilities. The position provides operational leadership for clinical trials supporting new or specific indications for Pulse Biosciences’ CellFX nsPFA percutaneous electrode system. The Director works with cross-functional product development teams and research staff on clinical readiness, trial design and documentation, study execution, vendor oversight, regulatory reporting and submissions, interpretation of results, and budget management. The role also hires, manages, and develops internal Clinical Affairs team members and contractors as needed. The position is located in Hayward, California, and candidates must reside in the San Francisco Bay Area. Travel of up to 30% may be required, including overnight domestic and/or international travel. The stated base salary range for Northern California is $190,000–$250,000; no relocation is offered.

Requirements

Bachelor's degree (BS, BA, or 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 multicenter IDE clinical trials or pivotal clinical studies intended to support FDA approvals.
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 current U.S. and European practice guidelines on percutaneous soft tissue ablation for 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 manage time and resources, 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 and willingness to handle hands-on work while also thinking strategically.
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 project 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 of protocols, informed consent forms, case report forms, 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 Investigations (ROPI) and Investigator Brochures (IB).
Support training for internal staff, study investigators, and other site personnel on proper trial conduct and product performance specifications.
Ensure investigators, site personnel, field team members, and Contract Research Organizations (CROs) properly perform procedures and techniques to mitigate study-device risks.
Oversee and manage key vendors, including CROs, Core Labs, and contractors.
Monitor studies for site initiation, patient recruitment, and enrollment, and take corrective action when needed.
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 to regulatory authorities and clinical research oversight entities, including IRBs and ethics committees, as necessary.
Support Regulatory Affairs during the submission process.
Ensure clinical results are clearly and concisely interpreted and documented 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, adhere to company financial goals, and work with accounting on accrual expenses for minimally invasive surgical studies.
Hire, manage, and develop internal Clinical Affairs team members and contractors as needed; set objectives and performance goals and empower them to deliver on the Company's strategic priorities.