Principal Clinical Pharmacometrician (PBPK/PD)

The RFT Group

Leinster

On-site

EUR 70,000 - 90,000

Full time

14 days+
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Job summary

The RFT Group is seeking a Clinical Pharmacologist in Ireland, Leinster. The successful candidate will have a strong quantitative background to support clinical development through pharmacokinetics, modelling, and simulation. Responsibilities include hands-on PK analysis, PBPK modelling, and collaboration with cross-functional teams. A BSc in Life Science and a post-graduate qualification is required, along with 5+ years of relevant experience. The role demands scientific leadership and effective communication of complex analyses.

Qualifications

  • 5+ years of experience in pharmaceutical or biotechnology environments.
  • Hands-on PK analysis experience.
  • Experience with clinical development programs and data handling.
  • Demonstrated ability to clearly communicate complex results.

Responsibilities

  • Provide hands-on PK analysis and modelling support for clinical studies.
  • Develop, implement, maintain, and interpret PBPK and population models.
  • Author and contribute to high-quality clinical pharmacology deliverables.
  • Support cross-functional teams by presenting findings.

Skills

PK analysis
PBPK modelling
Population PK/PD modelling
Data analysis using R
Data analysis using Python
Clinical pharmacology deliverables

Education

BSc in Life Science
Post-graduate qualification (PhD or MSc)

Tools

Phoenix WinNonlin
Simulations Plus GastroPlus
SimCYP
PK-Sim/MoBi
Phoenix NLME

Job description

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.
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