Sudarshan Pai

About Sudarshan Pai

Professional Summary As a Medical Monitoring & Safety Group Lead with over 12…

Experience

1. Group Lead Medical Monitoring & Safety Clinical Development

   Dr. Reddy's Laboratories

   Nov 2024 — Present · Hyderabad, IN

   In my current role at Dr. Reddy’s Laboratories, I lead the medical operational (Monitoring & Safety) oversight of all company-sponsored and consortium interventional clinical trials for biologics, with a primary focus on oncology. I provide strategic leadership and mentorship to a high-performing team of physicians and team leads, ensuring robust trial execution, patient safety, and regulatory compliance across a complex and diverse portfolio. Functioning at a director level, I’m deeply involved in the development and implementation of medical monitoring frameworks, safety oversight plans, and operational risk mitigation strategies.I provide therapeutic area and protocol-specific training to internal teams, CROs, investigators, and site staff, aligning all stakeholders to ensure protocol fidelity and operational readiness. My role also includes serving as the escalation point for complex medical and safety-related issues, including eligibility assessments, AE/SAE management, and protocol deviations.As a scientific contributor, I lead the review and authorship of essential clinical trial documents such as Investigator Brochures, Clinical Study Protocols, Informed Consent Documents (ICDs), Clinical Study Reports (CSRs), and regulatory submission dossiers. I also contribute to post-authorized safety study documentation such as SmPCs and package inserts. I’ve played an instrumental role in regulatory submissions for product approvals, contributing to executive summaries and clinical dossier sections that support drug registration and lifecycle advancement.Representing the organization at global regulatory forums—such as EMA Scientific Advice Meetings, FDA Type 2 Meetings, DSMBs, NDACs, and Advisory Boards—I offer expert clinical insights that influence governance and safety decisions. I also lead cross-functional integration with medical affairs, regulatory, pharmacovigilance, clinical operations, and data management teams to align timelines and quality outcomes.

Education

• Yenepoya University

  Doctor of Medicine (MD), Community Health and Preventive Medicine

  2012 — 2015

• Rajiv Gandhi University of Health Sciences

  Bachelor in Medicine & Surgery (MBBS) , General med

Skills

• Public Health Research
• Emerging Infectious Diseases