Team Member - IVIVC

1. Key Accountabilities

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

1. Regulatory deliverables

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

1. 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.

1. Programming / Technical Execution

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

1. Major Challenges

1. Key Interactions

Internal

External

• Clinical RD 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)

1. 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)

1. 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 modelling evidence reports for regulatory submission

Support cross-functional Influence on dose selection, trial simulation and labelling recommendations

Drive decisions with clinical and regulatory teams on

• Recommend dose, regimen, adjustments
• Simulate scenarios to optimize design
• Dose adjustments, warnings, instructions

Comments:

1. Skills Knowledge

Educational qualifications:

M.S/M.Pharm/PhD in Pharmaceutics, pharmacology, clinical pharmacy, PharmD

Relevant experience:

• 3-5 years of relevant technical expertise and experience in population PK/PD model development and validation and excellent hands on in POPPK/PD software(s), preferably PUMASAI.
• Should have handled cross functional teams and led the technical team