• Clinical development leader with 13+ years of experience in all phases of clinical development of treatments for hematologic malignancies and solid tumors o Phase 1/2 development including IB/study design/protocol generation, POC establishment, DLT and RP2D determination, generation of the global clinical development strategy, target product profile definition, risk assessment/mitigation, communication with KOLs and investigators, participation in site initiation visits, communication with ECs and IRBs o Phase 3 program management including planning/initialization/execution of investigator and DMC meetings, medical monitoring of pivotal trials, safety and efficacy data review, regulatory submissions resulting in US and European approvals of a first-in-class targeted therapy• Experienced medical monitor across all clinical trial phases (Phase 1/2 incl. dose escalation/DLT assessment, Phase 3 trials with a total of >620 patients); experienced in pharmacovigilance oversight• Author/contributing author of clinical (CSR, DSUR, IB, study protocols, ICF, med. monitoring plan) and regulatory documents (IND/IND updates, NDA, CTA, BTDR, ODA) and other regulatory communications (FDA, European Ministries of Health)• Confident representative of clinical development programs and cogent scientific presenter• Responsible and detail-oriented approach to output, review, integrity, interpretation and display of clinical trial data (safety and efficacy) for internal and external presentations• >6 years US academic research track experience in pediatric bone marrow/stem cell transplantation (Stanford University and University of Southern California) • Strong skills in leadership, communication, managing, and problem solving through competitive careers in industry (big pharma and biotech) and academia• Member of multiple professional clinical and translational research organizations (American Society of Clinical Oncology, Society of Pediatric Research, American Society of Hematology, American Association for Cancer Research, Society of Immunotherapy of Cancer); speaker, presenter, attendee at numerous national and international conferences• Excellent English and German scientific oral presentation and writing skills, basic knowledge of French