As a China Precision Medicine Lead - Oncology, 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 Oncology 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.
Primary Responsibilities:
- Lead the development, and execution of the overall Precision Medicine strategy for one or more AbbVie China Oncology programs, in partnership with global Precision Medicine strategy team
- Design and implement hypothesis-driven strategies to deliver evidence of target engagement, mechanisms of action/resistance, patient selection/CDx strategies (in partnership with CDx Lead), and other clinically relevant biomarker endpoints to advance the AbbVie Oncology pipeline
- Enable cross functional collaboration on the Precision Medicine strategy, leading the design, execution, analysis, communication, and publication of translational research and correlative clinical biomarker studies
- Review and refine Precision Medicine related sections in clinical study / regulatory documents (i.e. INDs, IBs, trial protocols/ops manuals, ICFs, IRB responses, HGRAC application dossier, HA Briefing Books, CSRs, etc)
- Be accountable for the overall China Precision Medicine strategy in oncology clinical studies, in compliance with AbbVie’s processes and regulatory requirements
- Provide oversight of external collaborations (academic/industry/consortia) that advance the overall Precision Medicine objectives for the program
- Prepare and present Precision Medicine deliverables to governance bodies, review forums, decision committees and project teams
- Represent Precision Medicine function at advisory boards and health authority interactions to advance translational research and clinical biomarker objectives for the program
- Drive scientific and/or technical innovation collaboratively with other members of Precision Medicine Oncology
- PhD, MD, or PhD/MD degree in a relevant scientific field (e.g. cancer biology, cancer genetics, molecular oncology, cell biology) with 5+ years of relevant experience in the pharmaceutical industry or equivalent
- Strong scientific background in solid tumors or hematology.
- Demonstrated leadership in development and execution of translational research and clinical biomarker strategies in early and/or late clinical development in oncology
- Experience leading cross-functional teams responsible for developing/implementing Precision Medicine strategies for oncology programs in a drug development setting
- Knowledge of clinical trial methodology, regulatory requirements governing clinical trials, companion diagnostics, protocol design, and/or experience in clinical development strategy preferred
- Strong passion to drive clinical innovation through Precision Medicine to improve outcomes for patients with cancer
- Excellent written and oral communication skills, strong organizational skills with attention to detail, and effective time management with an ability to distill complex issues and clearly articulate/present solutions
- Strong interpersonal and collaboration skills to work in a team-oriented, matrix environment, and the ability to interface with multiple cross-functional stakeholders
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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