Team Member - IVIVC

Job description

• 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 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 • 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