As a China Precision Medicine Scientific Lead - Immunology, he/she will have the opportunity to work in a fast-paced and highly collaborative environment to lead the development and execution of Precision Medicine strategies for Immunology programs in early/late-stage clinical development. The successful candidate will work with global Precision Medicine Team responsible for development and execution of translational research and clinical biomarker strategies (predictive/pharmacodynamic/resistance biomarkers, molecular response endpoints, indication selection and combination strategies) in alignment with the overall asset strategy, and ensuring successful execution of drug-diagnostic co-development in collaboration with the Companion Diagnostics group within Precision Medicine. This role requires an exceptional translational scientist with outstanding communication and leadership skills to drive effective decisions with key cross-functional stakeholders and enable execution of the overall Precision Medicine strategy for the program.
In this role you will:
- Lead the development, planning and implementation of translational and biomarker strategic plans for one or more clinical programs. Responsibility may extend from early translational development activities to mature product life cycle strategies
- Manage the design, conduct, interpretation, and reporting of biomarker data/activities in line with the development, regulatory, and commercial strategies
- Lead asset-specific translational projects/teams in a matrix environment.
- Work with internal Operations group to coordinate activities such as sample management, technical validation of assays both internally and at external CROs, review of SOWs, and data management
- In collaboration with appropriate stakeholders ensure that clinical translational budgets, timelines, publication strategies, and regulatory compliance requirements are incorporated into program strategy
- Author and review all translational medicine aspects of clinical and regulatory documents including development plans, study protocols, HGRAC application dossier, clinical study reports, and regulatory submissions.
- Lead scientific collaborations and therapeutic area key opinion leader interactions in collaboration with partners from Medical Affairs, Commercial, or other functions.
- Proactively consult primary scientific literature, keep current on state of art technologies and emerging concepts in immunology.