Pharmacometrics Project Lead, Director

RBW Consulting; Deutschland; Vor Ort; EUR 90.000 - 140.000; Vollzeit

Zusammenfassung

RBW Consulting is supporting a major biopharmaceutical company in building out its Quantitative Clinical Pharmacology capability. They seek an experienced Pharmacometrics Lead to set the vision and execute MIDD approaches across the development portfolio.

You will lead population PK/PD analyses, exposure–response modelling, and trial simulations, while advancing AI‑driven modelling and regulatory strategy. This role is on site in Germany with global collaboration.

Qualifikationen

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

Aufgaben

• Drive and deliver a robust Pharmacometrics strategy to guide dose optimisation, extrapolation, study design and regulatory planning.
• Apply and evaluate 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.

Kenntnisse

Pharmacometrics

Population PK/PD

Clinical trial simulations

Regulatory planning

Ausbildung

PhD in pharmaceutical sciences

Tools

R

Python

MATLAB

NONMEM

Jobbeschreibung

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.