Jitesh Rana, MD, MBBS
Dr. Jitesh Rana is a physician–executive with over 20 years of leadership experience in patient safety, pharmacovigilance, and medical affairs across the biopharmaceutical industry. He has worked with both agile biotech startups and large multinational companies, guiding products from early clinical development through global approval and commercialization. His experience spans oncology, rare diseases, neurology, cardiovascular medicine, and biologics.
LinkedIn profileProfessional Background
Before founding ClinRM, Dr. Rana served as Vice President of Drug Safety and Pharmacovigilance at Dyne Therapeutics, where he led global safety strategy and governance. He previously held leadership roles at SpringWorks Therapeutics and Amgen, building medical affairs and safety frameworks for marketed and pipeline assets. Known for collaborative leadership and a patient-first approach, he has chaired Safety Management and Dose Evaluation Committees and led cross-functional teams through critical development milestones and regulatory interactions.
Core Expertise
- Drug safety and pharmacovigilance (Phase I–IV and post-marketing)
- Benefit–risk management, signal detection, and safety governance
- Global regulatory strategy and safety submissions (US, EU, global)
- Medical affairs strategy, KOL engagement, and launch excellence
Career Highlights
- Secured worldwide marketing approvals through strategic engagement with FDA, EMA, and other health authorities.
- Built signal detection and safety monitoring frameworks for large cardiovascular outcome and oncology trials.
- Led global medical affairs teams across US, EU, and ROW for marketed products and expanding pipelines.
- Mentored and developed medical directors and safety physicians into senior leadership roles.
Education & Clinical Training
- Doctor of Medicine (MD), Pharmacology — University of Delhi, India
- Bachelor of Medicine and Surgery (MBBS) — University of Delhi, India
Therapeutic Focus
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