Working closely with our clinical development teams in both Asia and the USA, this individual is expected to be a major contributor to our oncology research teams within Janssen China R&D. He/she will be accountable for defining and driving the translational research strategy within several oncology drug development projects, in the solid and hematological tumor fields. This will include validation and selection of biomarkers (pharmacodynamic, predictive and patient selection), understanding of disease landscapes and evaluation/implementation of novel biomarker analysis technologies. The candidate will also form working relationships with CRO companies, academic labs and hospitals in the AsiaPacific region to leverage external resources to advance projects.
Technical Skill Requirements - Specific experience would include but not be limited to:
· Excellent understanding and experience of translational research for small molecule or antibody-based therapeutics (drug discovery and clinical experience would be a bonus)
· Expertise in understanding, executing and troubleshooting: in vivo efficacy studies, PD biomarker assay development, predictive biomarker analysis, combination studies ( in vitro and in vivo ), analysis of resistance mechanisms, analysis of drug modes of action, clinical biomarker analysis - again with crucial experience in oncology.
· Familiarity with ICH-GLP guidelines, clinical trial protocols, vendor evaluation/management and clinical trial operations.
· Highly motivated self-starter, able to excel within a matrix organization.
· Excellent awareness of oncology literature and emerging trends and drugs in the oncology area.
· Strong oral and written communication skills, fluent in English and Chinese.
· Critical thinker with good time management and delivery focus, able to independently design, execute and accurately interpret complex scientific experiments and data.
· Excellent team player with proven aptitude in leveraging expertise and resources across boundaries.
• The translational research (TR) lead takes ownership of the TR program: biomarker strategy, data interpretation and conclusions/impact on study(s) and decisions
• Pharmacodynamic analyses
• Mechanism of action (MOA) and Mechanisms of resistance (MOR)
• Predictive biomarkers (incorporating use of clinico-genomic data)
• Develops and champions the TR strategy for each phase of development
• Sets TR Team strategy and goals, schedules TR team meetings, generate agendas and meeting minutes, follow-up on action items - effectively represents the TR team to key stakeholders
Works effectively with TR Operations colleagues to ensure timely and efficient design and execution of contracts, research collaborations and vendor services. Provides scientific strategy, direction, interpretation and troubleshooting in all areas of TR scope.