Neurofeedback Based Executive Coaching
Executive coaching provides a powerful tool for personal and professional development, tailored specifically for leaders and high-level executives. My approach is a little different: I focus on internal dialogue, the stories the executive is telling themselves about themselves and others – and how shifting that can improve relationships, reduce stress and burnout, and create positive outcomes. At Neuro Ventures, I work with the executive on areas they and their supervisor identify to strengthen resilience and performance, such as:
- Leadership Growth
- Enhanced Self-Awareness
- Skill Development
- Objective Feedback
- Accountability and Goal Setting
- Stress Management
- Career Advancement
- Organizational Impact
- Personal Satisfaction
- Continuous Learning
CEO Coaching
My approach to CEO coaching is similar to coaching other executives, with an added focus on the isolation components of the role and creating systems of support for the CEO to excel. With startup CEOs, I might also focus on VC and investor approaches and communication to drive successful engagement with the financial community to support their business. My approach is neuro-focused, utilizing internal dialogue shifts to create changes that impact performance, self-awareness, and confidence.
FDA and PMDA (Japan) Regulatory Strategy, Review and Implementation
Whether applying for exempt status as a clinical decision support platform or seeking 510K device approval, I have experience authoring and navigating the breakthrough designation application, pre-submission, and pivotal trial design and submission. I will work with your executive team to guide and enhance agency interactions to improve the odds of a successful agency review and timely feedback. From the first question of what path to pursue, I know how to navigate getting answers on your post-approval commercial landscape to drive early regulatory pathway decisions and how to handle pricing strategy research for CMS and the agency bureaucracy to deliver answers quickly for your company.
Medical Advisory Role
Dr. Walter Greenleaf and I occasionally accept positions as advisory board members or board of director members for companies that need to add regulatory, XR, or general medical depth to their governing body.
Clinical Trial Review, Design and Implementation Projects
You have a product for the healthcare space, and now it’s time to prove efficacy. I have designed and delivered dozens of successful trials with human subjects in device, digital health, pharmacology, and clinical services programs. I will work with your team to write the protocol, identify and secure central IRB, and identify and contract with a CRO or directly with academic and commercial clinical trial sites in the US, Japan, South America, Singapore, and Europe.
Fractional CMO, Clinical Operations and Medical Affairs Executive
You need to bring onboard medical or science leadership but not full-time. Dr. Greenleaf and I both have a depth and breadth of experience in fractional leadership roles. This often overlaps with coaching approaches for the CEO if they are non-scientific or non-medical, helping them navigate the highly regulated world of healthcare and health technology.