Relationrx
Director, Clinical Pharmacology
London. Posted 2 months ago
The role
The Director, Clinical Pharmacology will drive the discovery and development portfolio by powering translation and optimizing dosing strategies. You will serve as the core quantitative and clinical pharmacology lead within cross-functional matrix project teams.
What you will do
- Build and own the clinical pharmacology and pharmacometric capability.
- Act as the Clinical Pharmacology lead for multiple concurrent programmes.
- Oversee clinical pharmacology input into study design across development phases.
- Work across Translational Safety, Translational Pharmacology and Biomarkers to integrate data.
- Lead modelling and simulation approaches including PK/PD, DDI risk assessment, PBPK, population PK/PD and QSP.
- Lead and manage external collaborations and CRO partnerships.
- Author relevant sections of regulatory documents including Investigator's Brochures, INDs and NDA/BLA/MAA submissions.
- Incorporate emerging AI-enabled approaches into clinical pharmacology workflows.
- Interface with cross-functional teams including DMPK, translational safety, toxicology, biology, clinical operations and regulatory affairs.
- Translate quantitative and biology data into actionable insights for stakeholders.
Required qualifications
- PhD, PharmD, or MD with a specialisation in DMPK, Pharmacometrics, in vivo/Clinical Pharmacology, or a related scientific discipline, or equivalent industry experience in a lead Quantitative Clinical
- Significant experience in the pharmaceutical or biotech industry in Quantitative Clinical Pharmacology, spanning all stages of development.
- Proven track record of applying Model-Informed Drug Development (MIDD) principles.
- Strong foundation of in vivo Pharmacology and Clinical Pharmacology principles and quantitative drug development.
- Demonstrable experience applying advanced quantitative modelling.
- Proven proficiency in core pharmacometric software such as NONMEM, R, Monolix, WinNonlin, GastroPlus, SimCyp.
- Understanding of the regulatory landscape and how to integrate diverse data.
- Outstanding communication skills.
Nice to have
- Experience across therapeutic modalities, small molecules, biologics and novel platforms alike
About the company
Relation is a TechBio company developing transformational medicines using single-cell multi-omics, functional assays, and machine learning. They operate with interdisciplinary teams in London to drive disease understanding from cause to cure.