Team Member – IVIVC (Population PK/PD Modeling)

About the role

We are looking for a Team Member to join our IVIVC (in‑vitro‑in‑vivo correlation) group. The role focuses on population pharmacokinetic/pharmacodynamic (PK/PD) modeling and simulation to support drug development and regulatory submissions.

Key responsibilities

• Manage data required for population PK (POPPK) analysis.
• Develop and validate population PK/PD and exposure‑response models to support clinical study design and biowaivers.
• Run clinical trial simulations for dose‑response, special populations, and alternative dosing regimens.
• Prepare POPPK reports for NDA/ANDA/505b2 submissions and develop model documentation.
• Support regulatory queries, label recommendations, and cross‑functional team interactions.
• Engage internal and external stakeholders to design solutions and resolve technical challenges.
• Organise meetings, manage vendor payments, and oversee logistics.
• Maintain modeling software, build automated workflows, and ensure QC, traceability, and compliance.

Required profile

• M.S., M.Pharm or PhD in Pharmaceutics, Pharmacology, Clinical Pharmacy or PharmD.
• 3–5 years of hands‑on experience in population PK/PD model development and validation.
• Proficiency with POPPK/PD software, preferably PUMASAI.
• Experience leading cross‑functional technical teams.

Required skills

• Population PK/PD modeling.
• POPPK/PD software (PUMASAI).
• Clinical trial simulation.