Team Member - BiopharmPK

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...