Jian Wang, PhD, MSRS, FCP

Results-driven leader with over a decade of leadership experience across clinical development, regulatory science, translational medicine, and clinical pharmacology—bridging FDA and industry to accelerate global drug development. Proven record driving IND-to-approval strategies, dose optimization, and biomarker integration for assets in oncology and other therapeutic areas. Former FDA leader and global head of regulatory science at pharma, and advanced FDA–industry collaborations on biomarkers, novel endpoints, and dose optimization. Experienced in building high-performing teams, leading global submissions, and integrating clinical, translational, and commercial functions to deliver innovative therapies. Expertise includes: • Regulatory strategy & global submissions (IND/BLA/NDA) • Translational biomarkers & precision medicine • Clinical pharmacology & model-informed development • Oncology, rare diseases, and complex modalities (ADC, bispecifics, CGT) • Cross-functional governance & portfolio leadership Secured regulatory approvals for multiple novel drugs and contributed to 20+ NDA/BLA approvals across FDA and industry roles.