Location: Shanghai, China

Organization: Oncology Translational Research (OTR), Asia

Position Description:

Janssen China R&D is seeking a highly motivated individual to join the Biomarker & Diagnostic Operations team. As a key contributor to the clinical biomarker and diagnostic strategy, he/she will be accountable for implementation and execution of clinical sample management, testing and data delivery activities for both early and later phase clinical programs in oncology. The successful candidate will have experience bridging both science and operations through cross functional partnerships, strategic project planning and facilitating key biomarker and diagnostic execution discussions.

Drives the implementation and execution of the clinical biomarker and diagnostic strategy for clinical programs in early and late-stage oncology, aligns with the global team to enable seamless operations of clinical programs in China and Asia pacific region. Creates and manages biomarker and diagnostic plan, timelines, budget, risk assessments and quality metrics during study startup, conduct and closeout. Works effectively with TR or CDx leads, procurement, contracting and compliance teams to evaluate vendor capability and certificate, and prepare contracts and statement of work; oversee the contract execution status and ensure the delivery meet program requirements. Works effectively and closely and with Clinical Operation team for HGRAO application for both molecular

eligibility screening and exploratory biomarker studies. Timely monitors sample/data collection by following the corporate compliance rules and governmental regulations throughout the study. Coordinates internal and external parties for regular or unscheduled HGRAO audits. Supports Clinical operation and biomarker central lab for site staff training and refreshes sample requirement from central lab. Leads central lab setup and management throughout the course of a study, works as a bridge between central lab and internal stakeholders and maintains good relationships with internal and external partners. Manages relationships with specialty testing vendors to ensure biomarker/diagnostic samples are processed, tested and data is reported to meet development timelines and specifications Works closely with data management to establish data collection and transfer specifications with testing vendors and local labs Contributes to the preparation of clinical documents such as lab report template lab manuals, informed consent forms, eCRF, sample/data management plan, early development plans and site training materials Works with scientific stakeholders to identify innovative bio-sample collection and processing techniques and ensures methods are implemented appropriately across clinical sites to the highest of standards Develops presentations and presents sample tracking/testing metrics at regular team meetings Supports scientific stakeholders to evaluate and implement new assays and relevant technologies as required by the program Participates and presents TR/CDx operation update in cross-functions study team meetings across clinical, translational research and diagnostics. Supports scientific leads to find central testing issues, provides efficient solutions from operation perspectives.

Provides sufficient operation support for pre-clinical studies and collaborative research with academic institutions. Trains new operation team members onboard to run in programs.

Qualifications:

Life Science degree (Bachelor Minimum) in scientific, medical, or healthcare area required. Additional qualifications: e.g., MS and/or project management certification desirable. 2+ years of work experience in a clinical development, diagnostics and/or Pharmaceutical/biotech R&D. Strong knowledge and understanding of clinical drug development strategic planning of clinical research, ICF, ICH GCP, GLP required. Project management experience is preferred Knowledge of oncology drug development and/or biomarker/diagnostic development is preferred. Excellent written and verbal communication skills in both English and Chinese. Ability to effectively and collaboratively work on China and global cross-functional teams.