The Senior Analytical Manager is responsible for leading the analytical method development, validation, and transfers at the clinical stage. The individual is also responsible for the analytical review and approval of methods, protocols, and reports for validation and stability studies. Assist in preparation and review of regulatory filings from early development to commercialization. The individual will also manage CMOs and CROs to meet the program timelines and objectives.
Karyopharm Therapeutics is a clinical-stage pharmaceutical company, based in Newton, MA, USA, focused on the discovery, development and commercialization of novel, first-in-class agents targeting nuclear transport for the treatment of cancer and other major diseases. Karyopharm is the industry leader in oral Selective Inhibitor of Nuclear Export (SINE) technology, developed to address a central mechanism of oncogenesis via the inhibition of exportins specifically XPO1. Selinexor, Karyopharm’s lead candidate, has been administered to patients with hematologic malignancies or solid tumors in clinical trials worldwide. Karyopharm is currently preparing for its first potential U.S. commercial launch in 2019.