Principal Clinical Pharmacologist, PBPK/PD Modelling
Our client, a Biotech company, now seek a Clinical Pharmacologist with a strong quantitative background to support clinical development through clinical pharmacology, modelling & simulation, and pharmacokinetic analysis.
The role is primarily technical and execution‑focused, with responsibility for study‑level delivery across all phases including PK analysis, PBPK and population PK/PD modelling, for the interpretation of clinical and nonclinical data, preparation of clinical pharmacology deliverables, and presentation of results in cross‑functional settings.
The role requires close collaboration with Clinical Operations, Biostatistics, Regulatory, CMC, Toxicology, and Non‑clinical, and the ability to translate quantitative analyses into clear, development‑relevant conclusions. This position requires scientific leadership, independence, and accountability for high‑quality outputs, while working in a fast-paced environment.
Responsibilities:
Provide hands‑on PK analysis and modelling support for clinical studies (Phase 1–3), including noncompartmental analysis, population PK/PD modelling, and PBPK modelling, as appropriate.
Develop, implement, maintain, and interpret PBPK and population PK/PD models to support dose selection, study design, device/formulation bridging, special populations, and regulatory questions.
Contribute to the design, analysis, interpretation, and reporting of clinical pharmacology components of clinical studies, under the direction of the Head of Clinical Pharmacology.
Author and/or contribute to high‑quality clinical pharmacology deliverables, including study reports or sections thereof, protocols, investigator brochures, modelling reports, and responses to regulatory questions.
Integrate clinical pharmacology and pharmacometrics insights with nonclinical PK/ADME, clinical safety, and efficacy data to support development decisions.
Support cross‑functional teams by presenting analyses and modelling results at study team meetings, internal governance forums, and selected external interactions.
Collaborate effectively with Clinical Operations, Biostatistics, and external vendors/CROs to ensure appropriate data flow, analysis standards, and timelines.
Critically evaluate data quality, assumptions, and limitations in PK and modelling analyses, and clearly communicate uncertainty and impact on development decisions.
Requirements:
BSc in Life Science, plus Post‑graduate qualification (i.e. PhD or MSc) in a relevant life sciences or quantitative discipline (e.g. clinical pharmacology, pharmacometrics, pharmaceutical sciences, biomedical, or similar).
5+ years of experience in pharmaceutical, biotechnology, and/or CRO environments, with hands‑on involvement in clinical development programs.
Hands‑on PK analysis experience using Phoenix WinNonlin.
Hands‑on PBPK modelling experience using tools such as Simulations Plus GastroPlus, SimCYP and/or PK‑Sim/MoBi, including model development, verification, and interpretation.
Experience using R (RStudio) and/or Python for data handling, analysis, and visualization.
Preference for population PK/PD modelling experience using Phoenix NLME, including model development and application.
Demonstrated ability to analyse complex datasets, build and interpret models, and communicate results clearly and practically to multidisciplinary audiences.
Willing to expand into adjacent areas (e.g. DMPK, TK, clinical trial operational support) as required by program needs.
For further details, please contact Larry on +353 1 – 2302400 /
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