Highly accomplished translational medicine expert with twenty years of global experience in areas including preclinical though post-marketing TM strategy development and implementation, research and clinical TM program management, bioanalytical development, global regulatory filings, lab, site and P&L management and due diligence. Experience in a variety of organizational types including pharma, biotech, CRO, start-up, and nonprofit. Therapeutic area expertise in neurology, oncology, vaccines, immunology and immuno-oncology. Proficiency with modalities including monoclonal antibodies, gene therapy, stem cell therapy, ADCs, bispecifics, small molecules, recombinant proteins, antisense therapy and radioimmunotherapy. Support of multiple marketed compounds including Prevnar 13, Rituxan, Zevalin, Tysabri and Zeposia. Core competencies: ▪ Translational Medicine (TM) strategy development and implementation for preclinical, clinical and post-marketing programs. ▪ Due diligence (determine scientific merits of research and clinical programs) to support in-licensing of compounds and acquisition of biotech companies. ▪ Biomarker, PK and ADA assay development and validation ▪ Initiation and management of Key Opinion Leader (KOL) programs in academic institutions to further translational research goals. ▪ Drafting of regulatory documents including IND, NDA and BLA packages. ▪ Frequent interactions with global regulatory agencies including FDA, MHRA, PMDA, EMA etc ▪ Timeline and budget management of numerous simultaneous research and development programs. ▪ Drafting and presentation of scientific data internally and externally. ▪ Contract Research Organization (CRO) management. ▪ Global clinical development.