China Biomarker Lead

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工作描述

ACCOUNTABILITIES

Under the guidance of the Global Biomarker Lead (GBL), provide scientific and operational leadership for Translational Medicine and Biomarker studies in China in collaboration with leading China-based Key Opinion Leaders (KOLs).

Establish and maintain strategic scientific relationships with China-based KOLs, academic institutions, CROs, translational research networks, and regulatory stakeholders to strengthen Takeda's translational and biomarker capabilities in China.

Serve as the China Biomarker Lead (CBL) for biomarker aspects of clinical trials in the assigned programs.

Accountable for the end-to-end planning, development, qualification, validation, deployment, operational oversight, and execution of biomarker assays at China-based CROs supporting Translational Medicine and clinical studies.

Partner closely with Quantitative Pharmacology & Translational Sciences(QPTS), Global Biomarker Leads, physician scientists, China/Asia Program Leads, and Program Managers to ensure clinical readiness, assay deployment, sample analysis, data delivery, and successful execution of biomarker strategies.

Lead cross-functional teams comprising China-based colleagues to evaluate and implement innovative biomarker technologies, platforms, and analytical approaches to enhance Translational Medicine and biomarker capabilities for China only studies (Non-interventional Translational Medicine studies, and Takeda interventional FIH and ePOC studies) as well as the China-specific global clinical development programs.

Partner closely with QPTS group to implement and oversee fit-for-purpose qualification and validation of clinical biomarker assays, ensuring scientific rigor, analytical performance, and regulatory compliance throughout the assay lifecycle.

Partner closely with QPTS group to oversee performance of China-based CROs and external laboratories, ensuring delivery of high-quality biomarker data, adherence to scientific and regulatory standards, operational excellence, and achievement of study timelines and milestones.

Under the guidance of GBL, support execution of the China-specific components of global clinical trials, ensuring seamless integration of China biomarker data and translational insights into global development and decision-making processes.

Work with GBL and Computational Biology Lead to author and review biomarker-related study documents, including exploratory Biomarker Analysis Plans (eBAPs), biomarker reports, clinical protocols, investigator brochures, clinical study reports, regulatory submissions, and governance documents related to China-specific studies.

Maintain awareness of emerging scientific advances, competitive intelligence, biomarker technologies, and the evolving China clinical research landscape to identify opportunities innovation, collaboration, and portfolio advancement.

Support business development and due diligence activities by evaluating translational medicine strategies, biomarker opportunities, external partnerships, and potential in-licensing opportunities relevant to Takeda's Immunology portfolio.

Represent Takeda on the committees related to Consortia and pre-competitive organizations in China.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: (List the essential and desirable education and competency requirements to perform the primary responsibilities of the job. Any minimum requirements should be noted.)

PhD degree and/or MD degree with 8+ years of experience in relevant field

At least 3 years of experience in translational biomarker research. Cross-functional team leadership desired. Managerial experience optional.

Experience in any combination of the following areas is required: rheumatology (e.g. SSC, PsA, AS), Inflammatory/Autoimmune disease (dermatology, respiratory, atopic diseases and/or IBD).

Recognized expertise in biomarker discovery and development and Translational Medicine as demonstrated by publications, regulatory submissions and/or national or international presentations

Excellent understanding of drug development, regulatory processes and clinical development

Good leadership abilities and proven ability to lead a team within a matrix organization as well as work independently

Strong analytical, oral and written communication in English and Chinese, problem solving and interpersonal skills

地点

中国上海中国北京

员工类型

员工

员工子类型

正式

时间类型

全职