Principal Scientist I

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工作职能：Discovery & Pre-Clinical/Clinical Development

作业子功能：Translational Discovery & Development Biomarkers

职位类别：Scientific/Technology

所有职位发布位置：Shanghai, China

职位描述：
Principal Scientist I, Immunology Clinical Biomarker Operations (China)

Location: China (Shanghai)

Department: Translational Sciences, Immunology

Functional Area: Clinical Biomarker Operations

Reports To: Sr. Principal Scientist, Clinical Biomarker Operations

Position Summary

The Principal Scientist, Immunology Clinical Biomarker Operations (China) will provide scientific and operational leadership for the implementation of biomarker strategies across Immunology clinical development programs conducted in China. The role is accountable for translating global biomarker plans into executable, compliant China study strategies and for delivering high-quality biomarker samples, assays, and data across early- and late-stage clinical programs in Immunology.

The successful candidate will serve as a China biomarker operations subject matter expert, integrating scientific objectives with regional regulatory requirements, laboratory capabilities, assay transfer needs, sample logistics, and data delivery. This individual will work in close partnership with global and regional Translational Sciences, Clinical Development, Clinical Operations, Regulatory, Quality, Legal, Procurement, Data Management, laboratories, vendors, and clinical sites.

Essential Functions

Lead the implementation and execution of clinical biomarker strategies for China cohorts in global and regional early- and late-stage clinical studies.

Develop and manage regional biomarker operational plans, timelines, budgets, risk assessments, quality metrics, and mitigation strategies from study start-up through closeout.

Develop regional study-specific operational strategies and lead day-to-day executions for study startup, local testing, sample exportation, sample management, regional regulatory documentation and governance of associated data.

Provide scientific and operational input into protocols, informed consent forms, investigator brochures, laboratory manuals, sample management plans, clinical study reports, regulatory documents, and site training materials.

Translate biomarker objectives and contexts of use into fit-for-purpose regional assay and laboratory setup, sample collection, testing, and data delivery plans.

Serve as the China biomarker operations lead for China Human Genetic Resources requirements and lifecycle management, partnering with local functions to determine regulatory pathways and lead applications, submissions, approvals, audits, and ongoing compliance.

Lead local laboratory selection, qualification, contracting, assay transfer, validation, implementation, readiness, compliance and lifecycle oversight.

Provide scientific oversight of biomarker technologies, including immunoassays, flow cytometry, proteomics, genomics, transcriptomics, immunohistochemistry, and other relevant platforms.

Manage specialty laboratories, central laboratories, CROs, and other vendors to ensure delivery against scientific, operational, quality, budget, and timeline expectations.

Oversee end-to-end biospecimen collection, processing, shipment, tracking, reconciliation, storage, testing, and final disposition to protect sample integrity and chain of custody.

Partner with Data Management, Biostatistics, Translational Sciences, and laboratory teams to establish data transfer specifications, conduct data reconciliation, resolve issues, and deliver analysis-ready biomarker datasets.

Identify operational and scientific risks early, lead issue resolution, escalate appropriately, and communicate impacts to study teams and leadership.

Support laboratory quality oversight, audits, inspections, data integrity reviews, and corrective and preventive actions.

Represent China Clinical Biomarker Operations on global and regional program, study, and governance teams.

Lead cross-functional collaborations and contribute regional insights to global biomarker, diagnostic, and translational strategies.

Drive continuous improvement by developing tools, standards, training, and scalable operating practices for China biomarker execution.

Provide technical guidance, coaching, and mentorship to colleagues and project teams; may lead workstreams or matrix teams without direct supervisory responsibility.

Build productive relationships with external experts, clinical investigators, academic collaborators, laboratories, and strategic partners to expand biomarker capabilities in China.

Principal Relationships

Internal: Translational Sciences and Medicine, Clinical Development, Clinical Operations, Regulatory Affairs, Quality, Data Management, Biostatistics, Clinical Pharmacology, Diagnostics, Legal, Procurement, Medical Writing, Global Biobank, and regional China development teams.

External: Clinical investigators and sites, central and specialty laboratories, CROs, assay developers, logistics providers, academic collaborators, consultants, and other strategic partners.

Education and Experience

PhD in immunology, molecular biology, pharmacology, biomedical sciences, clinical laboratory science, or a related discipline with at least 5 years of relevant pharmaceutical, biotechnology, CRO, or clinical research experience; or a master’s degree with at least 8 years of relevant experience.

Demonstrated experience leading clinical biomarker, translational science, diagnostic, or regulated laboratory activities within drug development.

Experience supporting China clinical studies and working with Human Genetic Resources requirements strongly preferred.

Hands-on experience with biomarker assay implementation, laboratory qualification or oversight, biospecimen operations, vendor management, and biomarker data delivery.

Experience supporting global, cross-functional, matrixed clinical development teams.

Immunology or immune-mediated disease experience preferred.

Required Knowledge and Skills

Strong knowledge of clinical drug development, biomarker strategy, assay lifecycle management, biospecimen operations, and clinical laboratory processes.

Working knowledge of ICH GCP, GLP, data integrity principles, informed consent requirements, and applicable China regulations and quality expectations.

Ability to integrate scientific, regulatory, and operational information and convert complex requirements into executable plans.

Strong project management, vendor oversight, risk management, problem-solving, and organizational skills.

Demonstrated ability to influence decisions, resolve ambiguity, and lead through a matrix without formal authority.

Excellent written and verbal communication skills in Mandarin Chinese and English.

Strong attention to detail, scientific judgment, and commitment to quality, compliance, and timely delivery.

Travel

Ability to travel within China, approximately 5~10%, based on business needs.

Required Skills:

Preferred Skills:
精通技术, 科学研究, 跨学科工作, 临床试验操作, 批判性思维, 生物标记, 项目群管理, 行业分析, 训练, 药物发现开发, 医疗合规, 医疗技术, 以安全为导向, 质量标准, 转化医学, 组织, 组织项目管理