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Biomarker Group Leader (Principal Scientist)

Roche
Shanghai, Shanghai, Mainland China
On-site

About this role

Job title: Biomarker Group Leader (Principal Scientist)

About the Role

At Roche/CICoR, you will lead the biomarker team to accelerate translational science across Oncology, Immunology, Neurology, Cardiovascular & Metabolism, and Ophthalmology in China. You will define China biomarker strategy for early and late-phase programs, serve as the biomarker SME on clinical development teams, and collaborate with global teams and CROs to deliver rigorous biomarker support that informs decision-making.

What You'll Do

  • Lead and mentor a multidisciplinary biomarker team while also acting as a hands-on contributor
  • Define and drive the China biomarker strategy for early and late-phase clinical development programs, including feasibility assessments and execution plans
  • Serve as biomarker subject matter expert on clinical development project teams, advising on disease biology and biomarker science
  • Support the generation and review of critical clinical development documents to ensure alignment with biomarker strategies
  • Partner with global biomarker and project teams to execute biomarker studies, including data analysis, interpretation, and reporting
  • Integrate preclinical, clinical, and real-world data to guide indication selection and develop patient enrichment strategies
  • Design and lead forward and reverse translational research studies with internal and external partners
  • Stay abreast of novel biomarker modalities and technologies to prioritize and harmonize biomarker platforms
  • Lead biomarker assay outsourcing, including overseeing development, transfer, validation, and CRO execution for non-clinical and clinical studies
  • Ensure data integrity through critical review and validation of CRO-generated results
  • Identify, select, and manage external vendors and collaborators to ensure timely delivery of high-quality data

What We're Looking For

  • PhD or MD in a relevant scientific field (e.g., Molecular Biology, Cell Biology, Oncology, Immunology)
  • Minimum of 5 years of pharmaceutical industry experience in Translational Medicine, Clinical Development, or Biology research, with a strong preference for biomarker experience
  • Proven experience in end-to-end clinical drug development, including drafting protocols and ICFs, and cross-functional interfaces
  • Deep familiarity with the regulatory landscape and competitive environment in China
  • Extensive knowledge of state-of-the-art biomarker technologies, including immunoassays, NGS, IHC, FACS, PCR, and imaging modalities
  • Demonstrated expertise in generating and interpreting data from diverse sample types to establish proof of biology, support dose selection, and develop enrichment strategies
  • Ability to thrive in a dynamic, inclusive environment with accountability for personal contributions and development
  • Strong leadership, collaboration, and communication skills; ability to influence stakeholders; proficient in English and Chinese

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