Principal PK/PD Scientist – Hepatology

Our client, a leading global biopharmaceutical company, is seeking a Principal PK/PD Scientist to provide scientific leadership across its hepatology and liver disease development portfolio. 

The successful candidate will apply advanced pharmacometric and quantitative pharmacology approaches to support decision-making across the drug development lifecycle, from early clinical development through registration and lifecycle management.

Key Responsibilities

• Lead PK/PD and pharmacometric strategies across hepatology development programs.
• Design and oversee population PK, exposure-response, dose optimization, and simulation analyses to inform key development decisions.
• Drive model-informed drug development (MIDD) initiatives to support clinical development, regulatory interactions, and portfolio strategy.
• Collaborate with Clinical Pharmacology, Translational Medicine, Clinical Development, Biostatistics, Regulatory Affairs, and Biomarker teams.
• Provide quantitative insights to support candidate selection, study design, dose justification, and benefit-risk assessments.
• Contribute to regulatory submissions, briefing packages, and responses to health authority requests.
• Represent Clinical Pharmacology and Quantitative Sciences on cross-functional project teams and governance committees.
• Mentor junior scientists and contribute to the advancement of pharmacometric 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 hepatology, including one or more of the following:
  • Metabolic dysfunction-associated steatotic liver disease (MASLD/MASH)
  • Chronic liver disease
  • Fibrotic liver disorders
  • Viral hepatitis
  • Cholestatic liver diseases
  • Rare hepatic disorders
• Advanced proficiency with NONMEM, Monolix, R, Phoenix NLME, or similar modelling platforms.
• Proven ability to influence development strategy through quantitative scientific leadership.
• Excellent communication and stakeholder management skills.