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

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/PD) structure and covariates
Define

📌 Team Member (Maharashtra)
🏢 Cipla
📍 Maharashtra