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上海市, 中国
Onsite
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
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)
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.