Location
mumbai, maharashtra, India
Posted
July 14, 2026
Job Description
Job Purpose
Organise and support the activities related to population pharmacokinetics (POPPK) to achieve the deliverables set forth for the identified projects in addition to building capability of the team to handle future challenges on deliverables.
Key Accountabilities
Data management, Modeling and Simulation deliverables.
- Manage the data required to perform the POPPK analysis.
- Develop and validate population PK / PKPD / exposure-response models to support designing clinical studies and facilitate biowaivers within the Model Informed Drug Development (MIDD) paradigm.
- Run clinical trial simulations to predict - Dose-response, Special population PK, Alternative dosing regimens etc.
Regulatory deliverables
- Prepare POPPK reports for Clinical pharmacology sections (NDA/ANDA/505b2) and develop model documentations.
- S...