Jahnavi Kharidia Email & Phone Number | Jahnavi Kharidia is a Senior Director, Clinical Pharmacology at Avidity Biosciences. She earned her Ph.D. (1996) degree from the University of Maryland. Most recently, she obtained her MBA program with Concentrations in HealthCare at Virginia Commonwealth University (2021). From 1996 to 1999, she was employed by the FDA as a reviewer in the Division of Bioequivalence. In 2000, Jahnavi joined National Institutes on Drug Abuse/NIH, where she served as project officer for ADME and Pharmacokinetics for drug abuse treatment programs related to the discovery and development of new medications. In May 2003, she joined Sepracor (now known as Sunovion) as a Director, Clinical Pharmacology. At Sunovion, she was responsible for planning, designing and overseeing clinical pharmacology studies as required throughout all stages of drug development in the respiratory and CNS areas. She has also worked at Infinity (Oncology) and Inidivior (Opioid Use Disorder). She has contributed to seven successful NDAs and supported filing of more than 13 INDs. She interacts very closely with other disciplines (medical director, regulatory, preclinical, biostatistics) to design studies in both healthy volunteers and patients. She is responsible for performing pharmacokinetic analysis of data, including PK/PD modeling and population PK/PD modeling. She also leads clinical pharmacology contributions to all regulatory documents including Investigator Brochures, EOP2 meetings and NDA/MAA. Jahnavi Kharidia is a registered pharmacist from the Maryland Board of Pharmacy and holds a Regulatory Affairs Certificate from the Regulatory Affairs Professional Society in the United States. PK Sofware knowledge and skills - Phoenix, WinNonlin, NONMEM, ADAPT II, SAS, PharSight Trial Simulator. Specialties: Pharmacokinetics, Pharmacodynamics, Model Based Drug Development (MBDD), Clinical Pharmacology, Pharmacometrics, U.S. Regulatory experience, Drug Metabolism, siRNA drug delivery

Jahnavi Kharidia

Jahnavi Kharidia is a Senior Director, Clinical Pharmacology at Avidity Biosciences. She earned her...
Richmond, Virginia, United States

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Jahnavi Kharidia’s Email jahnavi.kharidia@alkermes.com

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Jahnavi Kharidia’s Location Richmond, Virginia, United States

Jahnavi Kharidia’s Current Industry Alkermes

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Work Experience

Alkermes

Senior Director

2023-05-01 00:00:00 - Present

Avidity Biosciences

Senior Director, Clinical Pharmacology

2021-09-01 00:00:00 - 2023-05-01 00:00:00

Indivior Pharmaceuticals

Director, Clinical Pharmacology

2016-06-01 00:00:00 - 2020-12-01 00:00:00

Infinity Pharmaceuticals

Director Clinical Pharmacology

2013-08-01 00:00:00 - 2016-05-01 00:00:00

Sunovion Pharmaceuticals

Director, Clinical Pharmacology

2003-05-01 00:00:00 - 2013-08-01 00:00:00

Nidanih

Project Officer, Chemistry & Pharmaceutics Branch

2000-01-01 00:00:00 - 2003-05-01 00:00:00

Fda

Reviewer, Office of Pharmaceutical Sceince, CDER at US Food & Drug Administration

1996-05-01 00:00:00 - 1999-12-01 00:00:00

Skills

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Languages

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FAQ About Jahnavi Kharidia

Jahnavi Kharidia is located at
Richmond, Virginia, United States

Jahnavi Kharidia is a Jahnavi Kharidia is a Senior Director, Clinical Pharmacology at Avidity Biosciences. She earned her Ph.D. (1996) degree from the University of Maryland. Most recently, she obtained her MBA program with Concentrations in HealthCare at Virginia Commonwealth University (2021). From 1996 to 1999, she was employed by the FDA as a reviewer in the Division of Bioequivalence. In 2000, Jahnavi joined National Institutes on Drug Abuse/NIH, where she served as project officer for ADME and Pharmacokinetics for drug abuse treatment programs related to the discovery and development of new medications. In May 2003, she joined Sepracor (now known as Sunovion) as a Director, Clinical Pharmacology. At Sunovion, she was responsible for planning, designing and overseeing clinical pharmacology studies as required throughout all stages of drug development in the respiratory and CNS areas. She has also worked at Infinity (Oncology) and Inidivior (Opioid Use Disorder). She has contributed to seven successful NDAs and supported filing of more than 13 INDs. She interacts very closely with other disciplines (medical director, regulatory, preclinical, biostatistics) to design studies in both healthy volunteers and patients. She is responsible for performing pharmacokinetic analysis of data, including PK/PD modeling and population PK/PD modeling. She also leads clinical pharmacology contributions to all regulatory documents including Investigator Brochures, EOP2 meetings and NDA/MAA. Jahnavi Kharidia is a registered pharmacist from the Maryland Board of Pharmacy and holds a Regulatory Affairs Certificate from the Regulatory Affairs Professional Society in the United States. PK Sofware knowledge and skills - Phoenix, WinNonlin, NONMEM, ADAPT II, SAS, PharSight Trial Simulator. Specialties: Pharmacokinetics, Pharmacodynamics, Model Based Drug Development (MBDD), Clinical Pharmacology, Pharmacometrics, U.S. Regulatory experience, Drug Metabolism, siRNA drug delivery

Jahnavi Kharidia currently works in the Alkermes |

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Jahnavi Kharidia has prior
experience in the following industries:
Avidity Biosciences | Indivior Pharmaceuticals | Infinity Pharmaceuticals | Sunovion Pharmaceuticals | Nidanih | Fda

Jahnavi Kharidia has the following professional experience:
Alkermes | Avidity Biosciences | Indivior Pharmaceuticals | Infinity Pharmaceuticals | Sunovion Pharmaceuticals | Nidanih | Fda