Kathi Shah

About Kathi Shah

Life sciences leader with more than 25 years of experience across biotechnology, pharmaceutical, and medical device industries. My career has spanned clinical development, operations, quality, regulatory, and program leadership, with deep experience navigating complex domestic and international regulatory environments.Building on this foundation in development and regulatory strategy, I now work at the intersection of corporate development, compliance, and organizational leadership in support of advancing therapies for pediatric brain cancer. My focus includes building strategic collaborations, supporting corporate development initiatives, and helping establish the operational and strategic foundation needed to translate innovative science into meaningful therapies for children and families.Throughout my career, I have led cross-functional teams, mentored high-performing talent, and helped organizations strengthen operational effectiveness while navigating highly regulated environments. I am particularly motivated by opportunities to help emerging companies bring promising science forward and translate innovative research into therapies that can make a meaningful difference for patients.Selected Areas of Expertise:• Clinical Development• Quality & Regulatory Strategy• Corporate Development & Strategic Partnerships• Organizational Leadership• Process Improvement & Operational Excellence

Experience

1. SVP, Corporate Development & Compliance

   BrainChild Bio

   Feb 2026 — Present

   Lead corporate development and compliance initiatives supporting the company’s mission to advance therapies for pediatric brain cancer.• Identify, evaluate, and develop strategic collaborations, partnerships, and other growth opportunities that support the company’s scientific and business objectives.• Oversee compliance frameworks and regulatory alignment to ensure the organization operates effectively within complex domestic and international requirements.• Work closely with leadership, scientific teams, and external partners to support corporate strategy and organizational growth.• Contribute to external communications and stakeholder engagement, helping articulate the company’s mission, progress, and opportunities.

Education

• Babson F.W. Olin Graduate School of Business

  MS, Management

  2004 — 2008

• Babson F.W. Olin Graduate School of Business

  MBA, Business

  2004 — 2008

• Worcester Polytechnic Institute

  BS, Biomedical Engineering

  1994 — 1999

Skills

• Ich-Gcp
• U.s. Title 21 Cfr Part 11 Regulation
• 21 Cfr Part 11
• Design Control
• Manufacturing
• Ich Guidelines
• Fda
• Clinical Trials
• R
• Strategic Planning
• U.s. Food and Drug Administration (Fda)
• Cross-Functional Team Leadership
• Lean Business Processes
• CRO
• Healthcare
• Iso 14155
• CRO Management
• Medical Devices
• Capa
• Clinical Development
• Corrective and Preventive Action (Capa)
• Strategy
• Good Clinical Practice (Gcp)
• Start-Ups
• Iso 13485