KARUNAKAR REDDY
AVP Customer Success & Technology Adoption
Bangalore
Summary
Dynamic technology leader with over 20 years of experience in enterprise digital transformation and AI-driven innovation within the Pharmaceutical, Biotechnology, CRO, and Healthcare sectors. Expertise includes Clinical Development technologies, Product Engineering, and the creation of regulated digital platforms that enhance Clinical Operations, Clinical Data Management, Regulatory Affairs, Medical Writing, and Quality Assurance. Renowned for building high-performing global teams and delivering enterprise-scale solutions that drive business transformation through advanced AI and cloud technologies while ensuring operational excellence in GxP-regulated environments. Committed to leveraging extensive industry knowledge to foster innovation and improve organizational efficiency.
Overview
27
27
years of professional experience
Work History
Associate Vice President – Customer Excellence & Clinical Technology
Emmes
01.2026 - Current
- Lead Customer Success and enterprise adoption of AI-enabled Clinical Development and SaaS platforms.
- Partner with global Pharmaceutical, Biotechnology, and CRO customers to deliver strategic clinical technology solutions.
- Drive AI product evaluations, enterprise implementations, and technology adoption across customer organizations.
- Lead Executive Business Reviews (QBRs) and governance forums to maximize customer value and product adoption.
- Collaborate with Product, Engineering, and Clinical leadership to shape product strategy and innovation.
- Provide executive oversight for a $25M annual portfolio, driving delivery excellence and customer success.
Senior Director – Technology & Innovation
Emmes
01.2022 - 01.2025
- Led Product Engineering and R&D for the Advantage eClinical (AEC) platform, delivering enterprise-scale clinical technology solutions.
- Defined product strategy and technology roadmap aligned with customer, clinical, and business priorities.
- Drove AI and digital innovation to modernize clinical workflows and improve operational efficiency.
- Optimized product development and release processes, accelerating quality and time-to-market.
- Directed GxP, 21 CFR Part 11, CSV, and quality governance across the product portfolio.
- Led a global organization of 125+ professionals, including 3 Directors and 10 Managers, delivering strategic product engineering and innovation.
Director – Engineering & IT
Emmes
01.2016 - 01.2021
- Led global Product Engineering, IT Operations, and Enterprise Applications supporting Clinical Development platforms.
- Partnered with Clinical SMEs and Product Management to define product strategy and deliver customer-focused enhancements.
- Established GxP compliance and quality governance for enterprise clinical applications.
- Improved Agile delivery, engineering productivity, and release predictability through process optimization.
- Built high-performing engineering teams through strategic hiring, talent development, and leadership coaching.
Software Engineering Manager
Emmes
01.2012 - 01.2016
- Led delivery of Electronic Data Capture (EDC) solutions supporting global clinical trials.
- Directed study-specific solution design, development, validation, and deployment.
- Ensured compliance with GxP, 21 CFR Part 11, CSV, and ALCOA+ standards.
- Partnered with Clinical Operations and Data Management teams to deliver validated clinical systems.
Engineering Team Lead
Emmes
01.2006 - 01.2012
- Led development and implementation of enterprise clinical applications for global clinical research programs.
- Managed cross-functional engineering teams delivering scalable, high-quality software solutions.
- Drove Agile delivery, technical design, and quality engineering across multiple product releases.
- Mentored engineers and established engineering best practices to improve delivery excellence.
Senior Automation Developer
THOMSON
01.2004 - 01.2006
Python Developer
FCG
01.2004 - 03.2004
Member Technical Staff
SIRI Technologies
01.2003 - 12.2003
Software Engineer
Konark Industry
01.2000 - 01.2003
Education
Bachelor of Engineering -
Bangalore University
Skills
Strategic leadership
Business & Technology Strategy
Global Delivery & Operational Excellence
Organizational Development & Talent Leadership
Portfolio & Budget Management
Executive Stakeholder Engagement
Strategic Partnerships
Innovation & Change Leadership
Clinical Development (Phase I–IV)
Clinical Operations & Trial Execution
Clinical Data Management
Regulatory Affairs
Medical Writing
Drug Safety & Pharmacovigilance
Quality & Compliance
Global Product Engineering
Enterprise Architecture
Digital Transformation
Enterprise SaaS Platforms
Cloud & Platform Modernization
AI, Generative AI & Agentic AI
Intelligent Automation
Advanced Analytics
CTMS
EDC
CDMS
RTSM / IRT
eCOA / ePRO
eTMF
Regulatory Information Management (RIM)
Clinical Data Repositories
GxP
Computer System Validation (CSV/CSA)
21 CFR Part 11
EU Annex 11
ICH E6(R3)
ALCOA Data Integrity
Inspection Readiness
Delivery Governance
Timeline
Associate Vice President – Customer Excellence & Clinical Technology
Emmes
01.2026 - Current
Senior Director – Technology & Innovation
Emmes
01.2022 - 01.2025
Director – Engineering & IT
Emmes
01.2016 - 01.2021
Software Engineering Manager
Emmes
01.2012 - 01.2016
Engineering Team Lead
Emmes
01.2006 - 01.2012
Senior Automation Developer
THOMSON
01.2004 - 01.2006
Python Developer
FCG
01.2004 - 03.2004
Member Technical Staff
SIRI Technologies
01.2003 - 12.2003
Software Engineer
Konark Industry
01.2000 - 01.2003
Bachelor of Engineering -
Bangalore University