- Key Accountabilities

Accountability Cluster

Major Activities / Tasks
- 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
- Support regulatory queries and Label recommendations
- 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.
- Programming / Technical Execution
- Maintain the software(s), build automated workflows and ensure QC, traceability & compliance
- Major Challenges

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- Key Interactions

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)
- Dimensions
- 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)
- Key Decisions:

Decisions

Recommendations

Data Interpretation, Modelling Strategy and Submission Deliverables
- Define model adequacy, variability, covariate significance
- Select modelling approach (POPPK

📌 Team Member (India)
🏢 Cipla
📍 India