As a China Precision Medicine Scientific Lead - Neuroscience, 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 Neuroscience programs in early/late-stage clinical development. The successful candidate will work with a global Precision Medicine Team responsible for development and execution of translational research and clinical biomarker strategies (patient selection/predictive/pharmacodynamic/target engagement biomarkers, molecular and functional response endpoints, indication selection, and combination strategies) in alignment with the overall asset strategy. 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 AbbVie-developed compounds solely developed in China. Collaborate and provide expertise and input to partner-developed compound programs in China. Ensure development, planning, and implementation of global development programs, led by US-based PMED asset leads, are appropriate for the Chinese regulatory and research environment in China.
- Manage responsibility for one or more clinical programs that may extend from early translational development activities to mature product life cycle strategies.
- Regardless of development model, support the design and manage the conduct, interpretation, and reporting of biomarker data/activities in China in line with the development, regulatory, and commercial strategies.
- Ability to lead or support asset-specific translational projects/teams in a matrix environment.
- Work with internal Operations group to coordinate China-based 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 China-specific 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.