Principal PK/PD Scientist – Renal

Key Responsibilities

• Lead PK/PD and pharmacometric strategies across renal and nephrology development programs.
• Design, execute, and interpret population PK, exposure-response, dose optimization, and simulation analyses.
• Drive model-informed drug development (MIDD) initiatives to inform clinical study design, dose selection, and regulatory strategy.
• Collaborate with Clinical Pharmacology, Translational Medicine, Clinical Development, Biostatistics, Regulatory Affairs, Biomarker, and Discovery teams.
• Provide quantitative insights that influence program progression and portfolio-level decision-making.
• Support regulatory submissions and interactions with global health authorities through high-quality pharmacometric analyses and documentation.
• Contribute to scientific innovation through the application of advanced modelling and simulation methodologies.
• Mentor junior scientists and contribute to the continued growth of quantitative sciences capabilities across the organization.

What you'll need

• Significant experience within the pharmaceutical, biotechnology, or CRO industry.
• Demonstrated expertise in PK/PD modelling, population pharmacokinetics, exposure-response analysis, and model-informed drug development.
• Strong therapeutic area experience within renal disease, nephrology, or kidney-related disorders, including one or more of the following:
  • Chronic Kidney Disease (CKD)
  • Diabetic Kidney Disease (DKD)
  • IgA Nephropathy (IgAN)
  • Glomerular diseases
  • Acute Kidney Injury (AKI)
  • Proteinuric kidney diseases
  • Rare renal disorders
• Advanced proficiency with NONMEM, Monolix, R, Phoenix NLME, or equivalent pharmacometric software.
• Proven ability to influence cross-functional development teams and strategic decision-making.
• Strong communication, presentation, and stakeholder engagement skills.