Pharmacometrics Project Lead, Director

RBW Consulting; Brussel; Sur place; EUR 120 000 - 180 000; Plein temps

Résumé du poste

RBW Consulting is seeking a Pharmacometrics Lead for a major biopharmaceutical client. You will lead the vision and execution of model-based drug development (MIDD) across the development portfolio, driving PK/PD analyses, simulations, and regulatory-ready documentation.

The role emphasizes advanced pharmacometrics, clinical strategy, and cross-functional collaboration with global teams to optimise dose selection and trial design.

Qualifications

• PhD in pharmaceutical sciences, engineering, statistics or related field.
• 7+ years of industry pharmacometrics experience in drug development.
• Strong PK/PD population modelling and simulation-based decision support.

Responsabilités

• Drive and deliver a robust Pharmacometrics strategy to guide dose optimisation, extrapolation and regulatory planning.
• Apply and evaluate emerging technologies relevant to quantitative clinical pharmacology.
• Conduct population PK/PD analyses, exposure–response modelling and clinical trial simulations.
• Provide high-quality regulatory-ready analysis plans and reports.
• Manage external vendors and grow PMx capabilities internally.
• Develop team members in modern PMx and AI-driven modelling approaches.

Connaissances

Pharmacometrics

Population PK/PD

Disease progression modelling

Simulation-based decision support

Formation

PhD in pharmaceutical sciences, engineering, statistics or related field

Outils

R

Python

Matlab

NONMEM

Description du poste

I’m supporting a major biopharmaceutical company that is building out its Quantitative Clinical Pharmacology capability and looking for an experienced Pharmacometrics Lead. This is a strategic role for someone eager to push the boundaries of model‑informed drug development. This position is perfect for someone who thrives at the intersection of advanced pharmacometrics and clinical strategy. You will lead the vision and execution of MIDD approaches across the organisation’s development portfolio.

Key Responsibilities

In this role, you will drive and deliver:

• A robust Pharmacometrics strategy to guide dose optimisation, extrapolation, study design and regulatory planning.
• Application and evaluation of emerging technologies relevant to quantitative clinical pharmacology.
• Hands‑on delivery of population PK/PD analyses, exposure–response modelling, and clinical trial simulations.
• High‑quality documentation including regulatory‑ready analysis plans and reports.
• Management of external vendors and the opportunity to internalise and grow PMx capabilities.
• Scientific and technical development of team members in modern PMx and AI‑driven modelling approaches.
• Engagement with global regulatory agencies, including contribution to discussions across therapy areas.
• Close collaboration with project leads to ensure seamless integration of modelling outputs.

We are looking for candidates with:

• PhD in pharmaceutical sciences, engineering, statistics or a related field.
• 7+ years of industry experience in pharmacometrics and application in drug development.
• Strong background in population PK/PD, disease progression modelling, and simulation-based decision support.
• Technical skills in R, Python, Matlab, NONMEM or equivalent PMx software environments.