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Roche

Global pharmaceuticals and diagnostics company

Biomarker Group Leader – Principal Scientist

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeShanghai, ChinaNo salary listedIn-person

About the Job

Requirements

  • A PhD or MD in a relevant scientific field, such as Molecular Biology, Cell Biology, Oncology, or Immunology.
  • At least 5 years of pharmaceutical industry experience in Translational Medicine, Clinical Development, or Biology research; biomarker research or clinical biomarker development is strongly preferred.
  • Proven end-to-end clinical drug development experience, including drafting protocols and informed consent forms, and a solid understanding of interfaces such as Clinical Science, Clinical Pharmacology, Regulatory, Safety, Operations, and Biostatistics.
  • Deep familiarity with China's regulatory landscape and competitive environment.
  • Extensive knowledge of biomarker technologies, including immunoassays, next-generation sequencing, immunohistochemistry, fluorescence-activated cell sorting, polymerase chain reaction, and imaging modalities such as MRI, DXA, and PET.
  • Demonstrated expertise generating and interpreting data from diverse sample types to establish proof of biology, support dose selection, and develop patient-enrichment strategies.
  • Excellent communication and interpersonal skills in English and Chinese, and the ability to influence stakeholders and drive consensus.

Responsibilities

  • Lead and mentor a multidisciplinary team of biomarker experts while also serving as a hands-on individual contributor.
  • Define and drive the China biomarker strategy for early- and late-phase clinical development programs, including program-specific feasibility assessments and execution plans.
  • Serve as the 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, including protocols and informed consent forms, to ensure alignment with biomarker strategies.
  • Partner with global biomarker and project teams to lead biomarker study execution, including data analysis, interpretation, and reporting.
  • Integrate preclinical, clinical, and real-world data to guide indication selection and develop patient-enrichment strategies for CICoR programs.
  • Design and lead forward and reverse translational research studies with internal and external partners to support the preclinical and clinical portfolio.
  • Monitor novel biomarker modalities and technologies and drive prioritization and harmonization of biomarker platforms across the portfolio.
  • Lead biomarker assay outsourcing, overseeing assay development, transfer, validation, and execution at contract research organizations for non-clinical and clinical studies.
  • Ensure data integrity through critical review and validation of contract research organization-generated results.
  • Identify, select, and manage external vendors and institutional collaborators to ensure timely delivery of high-quality data.

Desired Qualifications

  • A background in biomarker research or clinical biomarker development is strongly preferred.

About the Company

Roche

Global pharmaceuticals and diagnostics company

Roche is a global leader in pharmaceuticals and diagnostics. It develops medicines and diagnostic tools that help detect, monitor, and treat diseases, using research and biotechnology to drive new therapies and tests. Roche combines drug development with in-house diagnostic products to support personalized medicine, where treatments are tailored to individual patients based on test results. Its approach differs from many peers by integrating drug discovery with diagnostic capabilities and by expanding its research through strategic acquisitions (like Genentech) to strengthen its biotechnology and R&D capabilities. The company’s goal is to improve patient outcomes and healthcare worldwide by delivering reliable medicines, accurate diagnostic tests, and data-driven care.

Company size
1-10
Company stage
IPO
Headquarters
Basel, Switzerland
Founded
1896

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