Clinical Pharmacology Lead

About the role

We are looking for a strategic, scientifically‑driven Clinical Pharmacology Lead to shape the development of innovative dermatology, immunology and oncology therapies. The role will guide clinical pharmacology and model‑informed drug development (MIDD) strategies from early‑phase programs through global regulatory interactions.

Key responsibilities

• Define and lead clinical pharmacology strategy for dermatology and oncology programs from pre‑IND through early clinical development.
• Design and oversee Phase I and early Phase II studies, including first‑in‑human, SAD/MAD, bioavailability, PK/PD, and maximum‑use studies for topical products, biologics and ADCs.
• Integrate PK/PD, PBPK, population PK, and quantitative systems pharmacology models to support dose selection, formulation optimization and study design.
• Analyze and interpret pharmacokinetic and pharmacodynamic data to inform development milestones.
• Author and review clinical pharmacology sections of INDs, IBs, CTDs, briefing books and scientific publications.
• Represent clinical pharmacology in global regulatory meetings (FDA, EMA, PMDA) and contribute to submission strategies.
• Oversee bioanalysis method development, validation and sample management for large and small molecules.
• Stay current on advances in topical drug delivery and biologic therapies, and contribute to biomarker and translational strategies.

Required profile

• PhD, PharmD or MD in Clinical Pharmacology, Pharmaceutical Sciences or a related discipline.
• Minimum 10 years of industry experience in clinical pharmacology, with a proven track record supporting NMEs in dermatology and/or oncology.
• Demonstrated experience in early‑phase clinical development and global regulatory submissions.
• Strong understanding of global regulatory expectations for clinical pharmacology data.

Required skills

• PK/PD analysis and modeling
• Population PK (PopPK) modeling
• Physiologically‑based PK (PBPK) modeling
• Quantitative systems pharmacology (QSP)
• Biostatistics
• Translational science
• Bioanalytical method development and validation
• Radiolabel study design and ADME profiling