China Biomarker Lead
Takeda · Shanghai
Job Description
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