Team Member -Iviivc

Job description

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