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Steve Kaesshaefer is an accomplished clinical operations executive with over 23 years of oncology drug development experience supporting several successful NDAs and IND filings. He brings global leadership experience leading clinical operations teams & programs from pre-IND, through Phase 1 and into large global pivotal phase 3 trials involving the development and execution of the program strategy and leadership of cross-functional and multi-site support. Steve provides strategic support and project management including financial/budget negotiations as well as managing global vendors and CROs for both insourced and outsourced programs.

His career started as a Clinical Research Associate (CRA) for Oxford Research International Corporation. He then moved to Roche Pharmaceuticals holding several positions in Study Management as a Study Leader & Operation Program Leader with several successful program NDAs supporting Capecitabine and Vemurafenib with companion diagnostics, as well as Avastin & Idasanutlin. Following 13 years at Roche, he moved to Bayer as the Head of Clinical Science Oncology Operations in early development where his team oversaw all Phase I/II early development oncology programs. He served as the senior director of oncology at Daichi Sankyo pharmaceuticals helping lead their development of Enhertu and other ADCs in the pipeline. He holds an MBA in Pharmaceutical Management from Fairleigh Dickinson University, and an MS in Molecular Biology & BS In Toxicology from Montclair State University with previous certifications of PMP, CCRA, APMP & MICP.