Scientist / Principal Associate, In Vitro Metabolism & DDI Assessment

About the role

Roche is hiring a Scientist / Principal Associate in Shanghai for its DDI (drug-drug interaction) assessment team. The role covers DDI evaluation strategies for small molecule candidates from early optimization through clinical development, experimental design and execution, quantitative bioanalysis, regulatory data preparation and DDI risk assessment.

Key responsibilities

• Drive DDI evaluation strategies for small molecule candidates from early optimization to clinical development
• Design and run in vitro DDI experiments on reversible or time-dependent CYP inhibition, CYP induction and reaction phenotyping
• Perform quantitative bioanalysis with LC/MS/MS and interpret metabolic datasets
• Direct internal studies and manage external CRO partners to ensure data quality and timelines
• Prepare DDI regulatory data packages aligned with ICH M12 guidance
• Run DDI risk assessments using in silico, static and dynamic models such as PBPK modeling
• Collaborate across disciplines and help develop novel in vitro ADME assays

Required profile

• Ph.D. in pharmacokinetics, DMPK or a related field with 2+ years of industry experience
• OR Master's degree with 5-8+ years of direct industry experience focused on DMPK and DDI evaluations
• Fluent English as working language (reading and writing required; oral communication a plus)

Required skills

• Deep expertise in enzyme kinetics and induction pathways
• Hands-on experience with LC-MS/MS-based metabolic assays
• Working knowledge of ICH M12 guidance
• Proficiency with PBPK and PK software (Simcyp, GastroPlus, Phoenix WinNonlin, PK-Sim) is a plus