Dr. Jitesh Rana, MD, MBBS
Global Leader in Drug Safety, Pharmacovigilance & Medical Affairs
Dr. Jitesh Rana is a physician-executive with more than 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 pharmaceutical companies, bringing a unique perspective on overcoming complex development challenges. His expertise spans the entire drug development continuum—from early clinical research through global regulatory approval and commercialization—covering both small molecules and biologics.
Known for his collaborative leadership and steady focus on patient well-being, Dr. Rana has built a career guided by one enduring principle: always put the patient first.
As Founder and President of ClinRM, a pharmacovigilance consultancy, he continues to help organizations navigate evolving safety regulations and design effective risk management strategies.
Professional Leadership
- Founder & President, ClinRM — Pharmacovigilance & Safety Consultancy (Boston, MA)
- Vice President - Drug Safety and Pharmacovigilance, Dyne Therapeutics (Waltham, MA)
- Therapeutic Area Lead, Medical Affairs, SpringWorks Therapeutics (Stamford, CT)
- Global Medical Affairs Lead & Global Safety Officer, Amgen (Thousand Oaks, CA)
Key Areas of Expertise
- Drug Safety & Pharmacovigilance (Phase I–IV, Post-Marketing)
- Medical Affairs Strategy & Execution
- Regulatory Submissions (INDs, NDAs, BLAs) — US, EU, Global
- Benefit-Risk Management & Signal Detection
- Product Lifecycle Management & Launch Excellence
- KOL Engagement & Scientific Communications
- Oncology, Rare Diseases, Neurology, Cardiovascular Medicine
Career Highlights & Impact
- Program leadership
- Led safety and medical affairs for products across oncology (GIST, breast, prostate, multiple myeloma), rare diseases (neurofibromatosis, GIST, DMD, muscular dystrophy), neurology (multiple sclerosis), and cardiovascular medicine (hypercholesterolemia).
- Regulatory excellence
- Secured worldwide marketing approvals through strategic label negotiations with FDA, EMA, and global health authorities. Authored multiple regulatory submissions including Periodic Benefit-Risk Evaluation Reports, Development Safety Update Reports, Risk Management Plans, and Investigator Brochures.
- Product launches
- Oversaw global medical affairs teams responsible for marketed and pipeline assets across the US, EU, and ROW. Played a key role in launching new products and implementing international Expanded Access Programs.
- Safety leadership
- Chaired Executive Safety Committees. Built signal detection, risk communication, and safety governance frameworks. Directed safety evaluations for CMC issues. Global Safety Officer for a leading cardiovascular outcomes trial.
- Team development
- Established medical arm of drug safety consultancy (BioSoteria) as first employee. Mentored and promoted medical directors to progressive leadership roles. Trained safety physicians and medical reviewers across multiple organizations.
Education & Clinical Training
- Doctor of Medicine (MD), Pharmacology — University of Delhi, India
- Bachelor of Medicine and Surgery (MBBS) — University of Delhi, India
Professional Affiliations & Expertise
Core Competencies
Patient Safety & Pharmacovigilance • Benefit-Risk Management • Medical Affairs Management • Clinical Development Safety • Post-Marketing Safety • Safety Governance • KOL Relationships • Product Lifecycle Management • Regulatory Strategy • Health Economics & Outcomes Research (HEOR) • Epidemiology • Training & Development
Therapeutic Areas
Oncology • Rare Diseases • Neurology (Multiple Sclerosis) • Cardiovascular Medicine • Immunology