Team Member - BiopharmPK

Cipla · India

Job Purpose

Organise and support the activities related to population pharmacokinetics (POPPK) to achieve the deliverables set forth for the identified projects in addition to building capability of the team to handle future challenges on deliverables.

Key Accountabilities

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.

Educational qualifications:

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

Relevant experience:

• 4-8 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 PUMAS.
• Should have handled cross functional teams and led the technical team.