Clinical Pharmacology Lead – Principal Scientist

About the role

The Clinical Pharmacology Lead will drive scientific advancement of clinical programs across multiple disease areas, leading quantitative and clinical pharmacology activities within global, cross‑functional project teams.

Key responsibilities

• Develop and execute Clinical Pharmacology and Model‑Informed Drug Development (MIDD) strategies for assigned assets across all development phases.
• Apply pharmacometric methodologies (population PK/PD, PBPK, QSP) to simulate trials, characterize exposure‑response relationships, and support dose selection, DDI assessment, and special population strategies.
• Lead the preparation of regulatory sections (IB, IND, NDA, BLA) and represent Roche as a subject‑matter expert in health‑authority interactions.
• Mentor junior scientists and contribute to digital innovation by integrating AI/ML approaches into quantitative workflows.

Required profile

• PhD, Pharm.D. or MD with specialization in Pharmacometrics, Clinical Pharmacology or related discipline.
• 5+ years of experience in quantitative clinical pharmacology within the pharmaceutical or biotech industry.
• Proven track record applying MIDD principles to support drug development decisions.

Required skills

• Proficiency with pharmacometric software such as NONMEM, R, SimCyp, MATLAB.
• Experience in population PK/PD, physiologically based PK (PBPK) and quantitative systems pharmacology (QSP) modelling.
• Strong knowledge of regulatory requirements for clinical pharmacology documentation.
• Ability to communicate complex quantitative data to cross‑functional leadership.