Director – Clinical Affairs - Minimally Invasive Surgery Market

About the Role

The Director of Clinical Affairs - Minimally Invasive Surgery Market (e.g., Thyroid) is responsible for the successful planning, directing and execution of the minimally invasive surgery market portfolio.  The position requires maintenance of up-to-date knowledge of all applicable US, international regulation and regulatory guidance for the conduct of clinical trials in compliance with all sponsored protocols, Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), as well as in-depth product and clinical knowledge of indications. She/he brings strong leadership, problem-solving, and decision-making abilities.

To Make an Impact, You Will:

• Provide operational expertise into the planning, implementation, and execution of clinical trials to obtain new or specific indication associated with the CellFX nsPFA percutaneous electrode system in accordance with project timelines, budget, and quality standards.
• Participate in discussions with cross functional product development teams on a regular basis and create documents required for clinical readiness.
• Contribute to the design of clinical trials including protocol development, informed consent form, case report forms/procedural worksheets, questionnaires, management of trial master files, and development of timelines, milestones, project plans/deliverables in conjunction with the research team.
• Conduct literature review for clinical documents (e.g., Report of Priors Investigation (ROPI) and Investigator Brochure (IB).
• Support training of internal staff, study investigators and other site personnel on the proper conduct of the trial and the review of specific product performance specifications.
• Ensure procedures and techniques are being properly performed by investigators, site personnel, and the field team members or Contract Research Organization (CRO) to mitigate risks associated with study devices.
• Oversee and manage key vendors such as CROs, Core Labs and contractors.
• Ensures studies are on track for site initiation, patient recruitment and enrollment, and take corrective actions where necessary to address issues.
• Ensure studies are conducted with high quality, according Procedures, Protocol(s) and Investigational Plans.
• May attend surgical procedures for training purposes.
• Problem solve and define a solution matrix for all clinical study issues as they arise.
• Manage clinical research reporting, such as reporting to regulatory authorities and clinical research oversight entities (IRB/Ethics) as necessary.
• Support Regulatory Affairs during the submission process.
• Ensures clinical results are interpreted and documented clearly and concisely for regulatory submissions and publications.
• Reviews, tracks, and approves clinical trial expenses; submit monthly clinical trial accruals to accounting.
• Develop and manage budgets for clinical projects and adheres to company financial goals, including working with accounting for accrual expenses of minimally invasive surgical studies.
• Hire, manage and develop Clinical Affairs internal team and contractors, as needed. Set objectives, performance goals and empower them to deliver on the Company’s strategic priorities.   

To Excel, You Will Bring:

• 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.
• Meticulous attention to detail.
• 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 the ever-changing work priorities and requirements of a dynamic, fast-growing company.
• 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.

Pay Range:

Compensation is determined based on a wide range of factors including location, job-related skills, experience, education, and training. It is not typical for an individual to be hired at or near the top of the range for their role. This pay range is specific to Northern California location. Base salary range: $190k - $250k. This position is located in Hayward, CA and candidates must reside in the San Francisco Bay Area. No relocation offered.