Associate Director – Principal Clinical Pharmacologist (Cell Therapy)

About the role

The Bioanalysis and Translational Medicine department is seeking an Associate Director‑level Principal Clinical Pharmacologist to lead pharmacology strategy for cell therapy programs such as CAR‑T and mRNA‑LNP/lentiviral products. The role bridges early research and clinical development, applying quantitative cellular kinetics and pharmacodynamics to optimise dosing and mitigate toxicities like cytokine release syndrome.

Key responsibilities

• Design, execute and report clinical pharmacology studies for first‑in‑human and Phase I trials, including dose selection and go/no‑go decisions.
• Develop short‑ and medium‑term clinical pharmacology plans aligned with overall program goals.
• Author core clinical documents (study protocols, Investigator’s Brochures, Clinical Study Reports) and manage CRO activities.
• Perform advanced PK/PD analyses using non‑compartmental methods, population modeling and exposure‑response simulations.
• Interpret and communicate PK/PD results to study teams and senior leadership.
• Serve as the independent clinical pharmacology lead on cross‑functional development teams and act as the subject‑matter expert for internal and external stakeholders.
• Prepare regulatory briefing documents and represent the project in health‑agency interactions.
• Establish departmental best practices, SOPs and standardized reporting templates.

Required profile

• Advanced degree (MD, MD/PhD, PhD or PharmD) in clinical pharmacology, pharmaceutical sciences or related discipline.
• Minimum five years of experience as a clinical pharmacologist in the pharmaceutical industry, research institutions or regulatory agencies.
• Proven track record designing, interpreting and reporting clinical pharmacology studies.

Required skills

• Pharmacokinetic/pharmacodynamic (PK/PD) analysis.
• Population modeling and exposure‑response simulation.
• Non‑compartmental analysis.
• Analysis of large multi‑dimensional datasets (flow cytometry, cytokines, molecular biomarkers).
• CRO management and clinical document authoring.