India
Dynamic and results-driven Clinical Research Leader with over 23 years of experience across the pharmaceutical and CRO industry, including 21+ years in global clinical operations. Proven expertise in driving strategic planning, operational excellence, and large-scale transformation across complex, multi-country clinical development programs. Extensive experience leading Phase I–IV clinical trials, including Oncology, Clinical Endpoint, PK Endpoint, and Real-World Evidence (RWE) studies, ensuring scientific rigor, regulatory compliance, and high-quality execution. Recognized for building and scaling centralized study support models, including establishing TMF and Centralized Study Support functions and recruiting centralized PMO teams in India to enable robust study tracking, analytics, reporting, and performance governance. Successfully led centralized study support teams for global RWE programs, coordinating cross-regional operations across the US and APAC to drive consistency, efficiency, and data quality. Strong track record in inspection readiness and regulatory compliance, including successful US FDA inspections with ZERO 483 observations, directly supporting sponsors in achieving US marketing authorizations. Demonstrated strength in financial planning, budget forecasting, and cost optimization, managing multimillion-dollar global study portfolios while maintaining operational efficiency and fiscal discipline. Trusted client partner and escalation point, known for resolving complex operational and regulatory challenges while delivering value-driven, sustainable solutions. Experienced in leading high-performing, multi-regional teams and driving standardization through digitalization, metrics-driven decision-making, and emerging AI-enabled solutions. Brings deep oncology domain expertise, a collaborative leadership style, and an unwavering commitment to patient safety, data integrity, and continuous improvement in fast-paced, evolving clinical environments.
Managing Clinical Operations in India.