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Key Accountabilities

I. 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

II. Regulatory deliverables • Prepare POPPK reports for Clinical pharmacology sections (NDA/ANDA/505b2) and develop model documentations • Support regulatory queries and Label recommendations

III. Cross-functional team (CFT) management • Engage with multiple internal (clinical regulatory) and external stakeholders (consultants and consulting firms) to design and streamline solutions for emerging challenges to achieve deliverables. Facilitate CFT to resolve the issues / concerns / problems / challenges pertinent to achieve deliverables • Additionally manage logistics such as organising the meetings, and payments to vendors.

IV. Programming / Technical Execution • Maintain the software(s), build automated workflows and ensure QC, traceability & compliance

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