Scientist / Principal Associate, In Vitro Metabolism & DDI Assessment

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职位

Key Responsibilities

DDI Strategy & Assessment: Drive drug-drug interaction (DDI) evaluation strategies for small molecule candidates from early optimization to clinical development.

Experimental Design & Execution: Design and execute in vitro DDI experiments, focusing on reversible or time-dependent CYP inhibition, CYP induction, and reaction phenotyping.

Quantitative Bioanalysis: Conduct quantitative bioanalytical work using LC/MS/MS systems and interpret sophisticated metabolic datasets.

Study Coordination & Quality Control: Direct internal studies and manage external CRO partners to guarantee exceptional data quality and timeline adherence.

Regulatory Compliance & Strategy: Prepare high-fidelity DDI regulatory data packages while remaining aligned with current global guidance (ICH M12).

DDI Risk Assessment: Perform DDI risk assessment using in silico, static model, and dynamic model (e.g. PBPK modeling) to guide compound optimization and inform clinical DDI strategy.

Cross-Functional Collaboration: Engage in multi-disciplinary project dialogues and develop the novel in vitro ADME assays.

Qualifications & Requirements

Education & Experience:

Ph.D. in Pharmacokinetics, DMPK, or related discipline with 2+ years of industry experience; OR

M.S. with 5–8+ years of direct industry experience focused on DMPK and DDI evaluations.

Technical Knowledge:

Deep expertise in enzyme kinetics and induction pathways.

Hands-on experience with LC-MS/MS-based metabolic assays.

Working knowledge of ICH M12 guidance.

Tools & Modeling: Proficiency with PBPK and PK software (e.g. Simcyp, GastroPlus, Phoenix WinNonlin, and PK-Sim) is a plus.

Language: Fluent English as working language (reading and writing are a must, oral communication is a plus)

我们是谁

打造更健康的未来是促使我们创新的动力。全球超过100,000名员工共同致力于推进科学，确保今天和明天的人们，都能获得高质量的医疗资源。我们的努力帮助了2600多万人使用我们的药物进行治疗，我们的诊断产品运行超过300亿次检测。罗氏通过赋能探索新的可能、激发创造力并保持高标准以提供突破传统的医疗解决方案，对全球的医疗环境带去推动和影响。

让我们一起，构建更健康的未来。

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