Zurich, Zurich, Switzerland
Fractional CMO for early-stage oncology biotech companies (pre-IND through Phase 1). Build and run clinical development under lean virtual operating models. Board-certified internist with a strong focus on early translational and clinical development in oncology. Expertise across hematologic malignancies and solid tumors. 20+ years of experience spanning pre-IND through FIH to Phase 3. Strong integrative knowledge of pre-clinical safety and CMC. Prior senior leadership roles include VP Clinical Science, Global Clinical Program Lead, Senior Medical Director, IDMC Chair, and co-founding CMO/CEO of a cross-border virtual biotech (Germany/US). Suitable engagements include fractional or interim CMO mandates, IND preparation, program stress testing and due diligence. Open for NED seats where stage and scope align. Selected achievements: - Authored ADC/anti-PD-1 Phase 1b expansion including Simon's 2-stage design, Project Optimus-aligned dose optimization and PD biomarker strategy. - Architected structured decision frameworks for clinical and translational go/no-go logic. - Authored Phase 1 protocol for a novel RIT/DDRi combination, including a PO-BLRM dose-escalation framework, applying Bayesian-adaptive escalation methodology aligned to modern oncology Phase 1 standards. - Chaired the IDMC for an NSCLC dose-escalation study. Led independent committee recommendations to the sponsor on safety signal review, cohort progression and dose-level decisions, and protocol amendments. - Participated as CMO at OBT during establishment of strategic discovery collaboration with Roche. - Served as Global Clinical Program Lead at MorphoSys during the out-licensing of an anti-CD38 myeloma program to Celgene. - On the operational side, at OBT I drove enrollment acceleration through investigator site roadshows across EU and US sites, engaging directly with principal investigators and site staff to build accrual momentum (~ 7x improvement in average monthly recruitment numbers vs. prior baseline) - Led US Translational Science on an interim basis through development candidate nomination for new IO molecules. - Set up and led 5+ Scientific Advisory Boards with KOLs from leading oncology centers, including Institute Gustave Roussy, Royal Marsden, Hospital 12 de Octubre, MD Anderson, Memorial Sloan Kettering and other high-profile sites.
Chief Medical Officer (fractional), leading OBT's Clinical Research & Development department, overseeing clinical development activities of their portfolio of antibody-drug conjugates (ADC)
Early oncology development. CMO and development leadership roles at FIH-stage biotech companies.
Interim medical leadership of the combination part of a radioimmunotherapy program
Early clinical development hem/onc
MorphoSys AG - Global Clinical Program Lead; early monoclonal antibody development Cantargia AB - Senior Medical Director (Interim); Senior Medical Director for Phase I/II combination program (CAN04) Otsuka Pharmaceuticals - International Medical Lead; early solid tumor development