Grinu Oommen | Sr. Medical Director, Head of Medical review
Moderna Therapeutics

I am a physician nephrologist with over 17 years of extensive experience in the pharmaceutical and biotech industries. My expertise lies in pharmacovigilance across diverse therapeutic areas, including neuropsychiatry, rare diseases, and neurology. Currently, I serve as Senior Medical Director and Global Head of Medical Review at Moderna, where I have established medical review standards, overseeing safety surveillance, and lead cross-functional collaborations to ensure compliance and safety monitoring for both marketed and investigational products. Throughout my career, I have held key positions at various organizations, including SAGE Therapeutics, Alexion Pharmaceuticals, Biogen, Perrigo, and Johnson & Johnson. I have contributed to regulatory filings, product safety strategies, and risk management frameworks, demonstrating expertise in regulatory interactions, clinical trials, signal detection, and safety oversight for innovative therapies. My leadership and strategic insights have supported successful IND, BLA, and NDA submissions, as well as pre- and post-marketing safety initiatives. As a dedicated advocate for patient safety, I combine clinical excellence with a deep understanding of regulatory requirements and operational efficiencies. I hold a robust academic background with a DM in Nephrology from Tver State Medical Academy, where I conducted impactful research on glomerulonephritis and rare kidney disorders. I continue to leverage my diverse skill set and global perspective to advance medical safety, drive innovation, and uphold the highest standards of care in the pharmaceutical industry.