Executive and Consultant with extensive clinical operations and project management leadership experience. Specializing in pharmaceutical and biotech clinical development and operations from discovery to IND and global NDA submissions, global clinical operations/clinical trial conduct, clinical document and manuscript writing, and multi-asset program management. Demonstrated leadership and management skills, clinical trial regulations, clinical and site training experience, KOL acquisition and development, competitive intelligence, and market research.
Extensive knowledge in protocol writing, regulatory submissions, and management of global, phase 1-4 studies in pediatric and adult oncology/hematology, neurology, CNS, and inflammation; Clinical management of product sale transition and divestiture of pre- and post-approval pharmaceutical products. Diverse disease background with a primary focus in oncology/hematology, including stem cell transplant, multiple myeloma, leukemia, lymphoma, ITP, lung, breast, head and neck, chemo-induced neutropenia, and chemo/radio induced mucositis. Additional experience in rare disease including, hemophilia, Battens’ disease; psoriasis, osteoporosis, JRA, hypercholesteremia, CHF, diabetic gastroparesis, diabetes, migraine, bipolar and depression.
