High-performing senior leader with over 20 years of experience in pharmaceutical and biotechnology industries. Demonstrated leadership and accomplishments in translating business vision into positive outcomes through efficient & effective application of Project Portfolio Management (PPM) and Operational ExcellenceSPECIALITIES• Drug discovery, development and commercialization• Project leadership fundamentals and best practices with PMP certification• Governance, Stage Gate-based NPI framework and project team empowerment • Due Diligence (DD) and strategic alliance management • Oncology, immunology, neurology, cardiometabolic disorders, rare & infectious diseases • Biologics, cell & gene therapy, small molecules, nucleic acids & peptides, drug/device combinations• In vitro diagnostics, medical devices and consumable/reagent development • Manufacturing process development and validation (cGMP and Six Sigma) • Regulatory submissions and compliance {IND/IDE/CTA, NDA/BLA/MAA, 505(b)(2), 510(k), 21 CFR Part 11}• Cost-benefit analysis, risk management and Change Execution Management (CEM)• Business and scientific acumenCAREER HIGHLIGHTS • Leadership and Team Building: Led and Built > 30 high-performing cross-functional Project/Program Teams across 3 different industries (Pharmaceuticals, Diagnostics & Life Sciences) • Project Delivery: Led or contributed to > 40 new product launches from early concept to commercialization with a combined revenue exceeding $2B (new indications, label expansions, IVD, life science products); led/supported numerous IND/IDE/CTA and NDA/BLA/MAA submissions• Business Process: Established a new organizational design at Merck Vaccine Manufacturing Division and implemented Stage-Gate NPI framework at GE Healthcare and United Neuroscience • Subject Matter Expert: Through accumulative experiences from companies of varying sizes, developed a comprehensive set of methodology, processes and tools in project, program & portfolio management that can be applied to virtually any type of organization (PPM Tool Box)
Listed skills include Cross Functional Team Leadership, Pharmaceutical Industry, Project Management, Process Improvement, and 13 others.