Amy Bardin-Spencer Ed. D

About Amy Bardin-Spencer Ed. D

I am an enterprise medical leader with extensive experience guiding global Clinical and Medical Affairs organizations within highly regulated, public-company MedTech environments. Throughout my career, I have focused on providing clear, credible medical leadership across the full product lifecycle—supportinginnovation and growth while maintaining scientific rigor, patient safety, and regulatoryaccountability.In my leadership roles, I have served as a trusted medical partner to executive leadership teamsand Boards, helping navigate complex decisions across FDA, EU MDR, PMA, and global postmarketlandscapes. I have led enterprise-wide evidence generation strategies, overseen medicalsafety and risk governance, and acted as medical authority on escalated scientific, safety,and compliance matters. My leadership style emphasizes sound science, well-defined governance,and practical execution aligned with public-company expectations.I bring deep experience collaborating cross-functionally with R&D, Regulatory, Quality, Legal,Commercial, and Corporate Development teams. This work has spanned early innovation andunmet-need assessment, clinical development and real-world evidence generation, post-marketsurveillance, and lifecycle management. I have also been closely involved in medical due diligencefor M&A activities for Clinical and Medical Affairs integration following acquisitions,with a focus on continuity, compliance, and long-term value creation.Equally important to me is fostering a strong culture grounded in ethics, accountability, andpurpose. I have built and led high-performing global teams that value transparency andcollaboration, and I place significant emphasis on tone-from-the-top leadership, compliantscientific exchange, and trusted, peer-level engagement with key opinion leaders, professionalsocieties, regulators, and external stakeholders.I am particularly drawn to opportunities where the Medical Affairs serves as both a strategicpartner and a steward of scientific credibility—supporting responsible growth while safeguardingpatients, clinicians, and organizational reputation.

Experience

1. President

   The Association For Vascular Access Foundation

   May 2021 — Present

Education

• Quantic School of Business and Technology

  EMBA

• Grand Canyon University

  MS, Organizational Leadership

  2008 — 2010

• Grand Canyon University

  Doctor of Education - Ed.D, Organizational Leadership

  2017 — 2021

• Grand Canyon University

  BSHS, Health Sciences

  2006 — 2008