Jahnavi Kharidia
About Jahnavi Kharidia
Jahnavi Kharidia is a Senior Director at Alkermes with extensive experience in clinical pharmacology and regulatory affairs.
Current Role at Alkermes
Jahnavi Kharidia currently holds the position of Senior Director at Alkermes. In this role, she oversees various aspects of clinical pharmacology, leveraging her extensive expertise in pharmacokinetics, pharmacodynamics, and regulatory affairs. Her responsibilities include leading clinical pharmacology contributions to regulatory documents and interacting closely with multiple disciplines such as medical directors, regulatory, preclinical, and biostatistics. Jahnavi's work is critical to the design of studies in both healthy volunteers and patients.
Previous Experience at Avidity Biosciences
From 2021 to 2023, Jahnavi Kharidia served as Senior Director, Clinical Pharmacology at Avidity Biosciences, Inc. During her tenure, she was responsible for performing pharmacokinetic analysis and contributing to the design of clinical studies. She also supported the filing of several investigational new drug (IND) applications and worked closely with various disciplines to ensure the success of clinical programs.
Educational Background
Jahnavi Kharidia has a robust educational background that includes a Ph.D. in Pharmaceutical Science from the University of Maryland Baltimore (1991-1996). She also holds a Master of Business Administration (MBA) in Health/Health Care Administration/Management from Virginia Commonwealth University (2019-2021). Additionally, she has achieved certifications as a registered pharmacist (R.Ph.) from the Maryland Board of Pharmacy and the Massachusetts Board of Pharmacy, and holds a Regulatory Affairs Certificate (RAC) from the Regulatory Affairs Professional Society.
Expertise and Skills
Jahnavi Kharidia has specialized expertise in pharmacokinetics (PK), pharmacodynamics (PD), model-based drug development (MBDD), and clinical pharmacology. She is proficient in PK software such as Phoenix, WinNonlin, NONMEM, ADAPT II, SAS, and PharSight Trial Simulator®. Her skill set extends to U.S. regulatory experience, drug metabolism, and siRNA drug delivery. She has significantly contributed to the successful submission of seven New Drug Applications (NDAs) and supported over 13 Investigational New Drug (IND) applications.
Past Roles and Contributions
Throughout her career, Jahnavi Kharidia has held pivotal roles across various pharmaceutical and biopharmaceutical companies. She served as Director of Clinical Pharmacology at Indivior Pharmaceuticals (2016-2020) and Infinity Pharmaceuticals (2013-2016), and was with Sunovion Pharmaceuticals Inc. for a decade (2003-2013). She has also worked at NIDA/NIH and the FDA. In these roles, she was responsible for pharmacokinetic analyses, PK/PD modeling, and regulatory submissions, as well as contributing to investigator brochures, End-of-Phase 2 meetings, and NDAs/MAAs.