Global Diagnostic Innovation, Johnson & Johnson Innovation + more
20 years of broad and progressive management and leadership roles in IVD, pharmaceutical and biotechnology industry. Extensive experiences in R&D leadership roles for portfolio / program / project / people management, strategic planning and execution for IVD, Blood Screening, protein therapeutics and vaccines, and for technology development. Proven track record of establishing R&D functional excellences, developing innovative technologies and directing/leading technical due diligence for M&A and licensing; managing R&D budgets, directing and managing multidisciplinary teams and functional departments, advancing R&D pipelines, and meeting/exceeding organization and program objectives. Track record of building talent pipelines and extensive experience in talent management.
Experiences and roles/responsibilities include:
• Develop and/or execute business strategies for genetics, oncology, infectious disease, metabolic disease, and neuroscience
•Develop and drive technical strategies for drug and companion diagnostics co-development
• Recruit and develop talents, build functional departments and project teams, develop and implement product development and project management tools and processes, grow organization.
• Direct, manage and oversee R&D functions for biological drug and vaccine development, blood screening, and IVD product development: Biomarker Development, Assay Development, System and SW Engineering, System Integration, Design Transfer, Technology Transfer, Technology Development, Process Development and Validation, Pilot Production, Analytical Method Development and Method Validation, QC Testing, Project Management (PMO) and Scientific Affairs.
•Drug development CMC lead or core team member: Phase I, II and III IND, and NDA/BLA submissions for biological and blood screening.
•Technology assessments and strategic alignment for M&A and BDL initiatives
•Strategic alliance with partners and vendors, drive and manage collaborations