Principal Scientist I/II, BMD

Key Responsibilities:

• Serves as Biomarker Study Expert (BSE) in China and Global studies, lead clinical biomarker operational study strategy and biomarker study plan implementation in TM clinical studies including providing input and reviews of clinical synopsis, study protocols, and other biomarker study operations documentation. 
• Represent BMD platforms and modalities in Global and China CTT including soluble, cellular, genetics, imaging and digital endpoints. Partner with BMD BML and SME and provide biomarker and operational expertise on all assigned clinical studies e.g. lead the BM setup, sample tracking/reconciliation, assay set up, data flow, vendor set up, biomarker sections of clinical study report and biomarker study closure
• Independently provide operational support to clinical teams and clinical studies (both global and China studies) focusing on biomarker samples and PK sample including reviews of clinical study protocol, preparing site operations manuals, informed consent forms, sample collection table, instruction manual, central lab protocol/manual, and eCRF and other biomarker and PK sample operation logistics and coordination including study setup, sample tracking/reconciliation, assay and vendor set up, sample/data upload and study closure
• Effectively engage and partner with BMD subteams and biomarker LF experts in China and Global teams to ensure on time internal and external (vendor) biomarker deliverables. Update study and project information in relevant meeting, reports and IT systems
• Serve as a scientific monitor i.e. assay set up, assay transfer and implementation, and monitor biomarker assays at external service providers in one or more biomarker modalities (e.g. Immunoassay, LC-MS, Flow cytometry, tissues, genetics, digital endpoint and devices, etc.) 
• Serve as expert for relevant China-specific regulations and policies (e.g. HGRAC, bio-sample export/import). Conduct feasibility analysis before study allocating to China and provide China biomarker solutions to ensure timely study execution in China.
• Continuously strengthen China local biomarker vender capabilities based on the study needs to enable efficient bio-assay development transfer in China
• Collaborate with other TM and BMD functions and lead biomarker clinical operation processes, continuous improvement initiatives and innovations in LEO and BMD
• In collaboration with relevant BMD managers, contributes to talent and career development of LEO associates in China. Provide supervision and mentorship to colleagues in LEO and BMD.

Essential Requirements:

• MS in life science with 10 years of combined experiences or PhD in life science with 8 years of combined experience in clinical operations and clinical biomarker analysis (method development, validation and sample analysis) in CRO or industry
• Fluent in English as working language.
• Laboratory knowledge and experience with several biomarker modalities and platforms e.g. immunoassays, LC-MS/mass spectrometry, cellular biomarkers, genetics, tissue or digital endpoints/digital devices.

• Direct experience in troubleshooting of assays in CRO and assay transfer to CROs and sample analysis as well as managing relationship and performance of external service providers/CROs including specialized laboratories

• Deep knowledge of clinical study set up and clinical operations, clinical sample analysis

• Extensive and in-depth knowledge of the drug development process, biomarkers and working with clinical translation research or global clinical studies
• In depth/expert knowledge of regulatory requirements e.g. data integrity, GCP, GLP, etc. Knowledge of China regulation is a plus, e.g. HGRAC, sample exportation.

• Highly self-motivated and collaborative, with a demonstrated ability to work effectively in matrix teams.

Desirable Requirements:

• Emerging leader who is passionate about driving patient-centric operational  innovation and partnership with external service providers/CROs and internal subject matter experts 
• Experience working in a global organization and matrix environment (multiple roles/connections and stakeholders)

• Strong global project management, problem solving, influencing, communication and leadership skills. Concise oral and written communication skills
• Highly self-motivated and collaborative, with a demonstrated ability to work effectively in matrix teams.