Team Member - IVIVC

Accountability Cluster

Major Activities / Tasks

1. 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

2. Regulatory deliverables

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

3. 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.

4. Programming / Technical Execution

• Maintain the software(s), build automated workflows and ensure QC, traceability & compliance

Internal

External

• Clinical R&D for execution and update of project status (as per need basis)
• Regulatory department for execution and update of project execution (as per need basis).

• Technical consultants for inputs and issue resolution (as per need basis)

• Number of successfully executed projects with preset deliverables
• Number of projects completed within given timelines and budget
• Number of lapses in agreed work process (i.e., tasks both technical and logistical)