Kalpesh A. Shah
Head - Clinical trials
- Role
- Head - Clinical Trials at Vimta Labs Ltd
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Kalpesh A. Shah
I’m a clinical research executive with over two decades of experience leading global Phase I–IV trials, biosimilar development, and regulatory strategy across pharma, biotech, and CRO environments. My journey has taken me from hands-on protocol design to boardroom-level decision-making, with successful submissions to FDA, EMA, DCGI, and other regulatory bodies.I specialize in building high-performing teams, streamlining clinical operations, and driving innovation in biosimilars and NDA. Whether it’s navigating complex regulatory landscapes or optimizing trial efficiency, I bring a strategic mindset and a collaborative spirit to every challenge.I\'m passionate about mentoring emerging talent, shaping regulatory frameworks, and advancing global health through evidence-based research. Let’s connect if you’re working at the intersection of science, strategy, and innovation.
Experience
Head - Clinical Trials
Aug 2024 — Present · Hyderabad, IN
End to end clinical trial services
Education
Gujarat University
PhD (Pharmacology), Pharmacology
2012 — 2016
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