Director, Clinical Pharmacology & Modelling

Hlx Life Sciences; England; Sur place; GBP 120 000 - 180 000; Plein temps

Résumé du poste

Hlx Life Sciences seeks a Director of Clinical Pharmacology to build our pharmacology capability within Drug Discovery. You will lead quantitative pharmacology across cross-functional teams, applying MIDD to translate nonclinical PK/PD into human development strategy and inform dose selection.

You will own strategy across IND enabling studies through Phase 3, lead modelling and simulation (PK/PD, PBPK, population PK/PD, QSP), and partner with Translational Safety, Biomarkers, DMPK and Regulatory

Qualifications

• Experience leading clinical pharmacology strategy across multiple programmes.
• Strong background in PK/PD modelling and simulation.
• Familiarity with regulatory submissions (IB, IND, NDA/BLA/MAA).

Responsabilités

• Own clinical pharmacology strategy across programmes from IND enabling to Phase 3.
• Lead modelling and simulation including PK/PD, PBPK, and QSP.
• Partner with Translational Safety, Biomarkers, DMPK, and Regulatory to embed pharmacology.
• Author regulatory submissions (IB, IND, NDA/BLA/MAA) and interact with regulators.
• Manage CRO partnerships and integrate AI-enabled approaches into workflows.

Connaissances

Quantitative analysis

Cross-functional leadership

Pharmacometric modelling

MIDD approaches

Outils

PBPK modelling

Population PK/PD

QSP

DDI risk assessment

Description du poste

Hlx Life Sciences seeks a Director of Clinical Pharmacology to build our pharmacology capability within Drug Discovery. You will lead quantitative pharmacology across cross-functional teams, applying MIDD to translate nonclinical PK/PD into human development strategy and inform dose selection.

You will own strategy across IND enabling studies through Phase 3, lead modelling and simulation (PK/PD, PBPK, population PK/PD, QSP), and partner with Translational Safety, Biomarkers, DMPK and Regulatory