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Biomarker Group Leader (Principal Scientist)

roche · Shanghai

New
Senior 🇬🇧 English
NGS IHC FACS PCR Immunoassays

Job description

About the role

Roche's CICoR team in China accelerates early-phase clinical development through patient selection and enrichment and the generation and analysis of clinical biomarker data, supporting proof-of-mechanism demonstrations and faster decisions. The Biomarker Group Leader leads the biomarker team and delivers rigorous biomarker support across multiple disease areas, including Oncology, Immunology, Neurology, Cardiovascular & Metabolism and Ophthalmology, advancing translational science in China.

Key responsibilities

  • Lead and mentor a multidisciplinary team of biomarker experts while remaining an individual contributor.
  • Define and drive the China biomarker strategy for early- and late-phase programs, including feasibility assessments and execution plans.
  • Act as biomarker subject matter expert on clinical development project teams, advising on disease biology and biomarker science.
  • Support the generation and review of clinical development documents such as protocols and informed consent forms.
  • Partner with global teams to run biomarker studies, including data analysis, interpretation and reporting.
  • Integrate preclinical, clinical and real-world data to guide indication selection and patient enrichment strategies.
  • Design and lead forward and reverse translational research studies with internal and external partners.
  • Stay ahead of new biomarker modalities and technologies to harmonize biomarker platforms across the portfolio.
  • Lead biomarker assay outsourcing, overseeing assay development, transfer, validation and execution at CROs, and validate CRO results for data integrity.
  • Select and manage external vendors and collaborators to deliver high-quality data on time.

Required profile

  • PhD or MD in a relevant scientific field (e.g. Molecular Biology, Cell Biology, Oncology, Immunology).
  • At least 5 years of pharmaceutical industry experience in Translational Medicine, Clinical Development or biology research, with a strong preference for biomarker research or clinical biomarker development.
  • Proven end-to-end clinical drug development experience, including drafting protocols and informed consent forms.
  • Deep familiarity with the regulatory landscape and competitive environment in China.
  • Excellent communication in English and Chinese, with the ability to influence stakeholders and drive consensus.

Required skills

  • Extensive knowledge of biomarker technologies: immunoassays, NGS, IHC, FACS, PCR and imaging modalities (MRI, DXA, PET)
  • Ability to generate and interpret data from diverse sample types to support dose selection and patient enrichment
  • Strong leadership, coaching and analytical skills

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Source : ats:workday

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Published 9小时前

Expires 1个月后

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roche

Shanghai