Basel, Basel, Switzerland
Physician-scientist with dual MD and PhD training, specializing in hematology and oncology. I bring a track record of advancing therapies from Phase II through post-marketing, including leading regulatory submissions that contributed to approvals and label expansions in both malignant and non-malignant hematology. At Gilead/Kite, I lead the ex-US RWE strategy for CAR-T therapies, serving as study director for post-marketing commitments and guiding cross-functional teams across Clinical Development, Regulatory, Market Access, and Safety. Previously at Roche, I designed and delivered RWE programs that informed FDA/EMA submissions, shaped pivotal trial design, and drove scientific publications while also contributing RWE insights to M&A assessments. Direct experience interacting with FDA and EMA, including leading agency meetings, authoring briefing documents, and negotiating label language. Recognized for building collaborative partnerships with investigators and health authorities to accelerate development timelines and expand patient access.
Designed and managed global Phase II–IV studies for respiratory assets, ensuring study execution and regulatory compliance. Drove evidence-based strategy for advisory boards and label extension submissions Synthesized scientific literature on treatment effectiveness and safety, providing critical input for HEOR models to support payer engagement.
PhD thesis on asthma and COPD phenotypes in electronic healthcare records.
⦁ Master’s degree in epidemiology directed towards quantitative research and public health, with a substantive component on clinical trial methodology and statistics.
Directed global RWE strategy for non-malignant hematology (emicizumab, crovalimab), generating real-world safety and effectiveness data that informed regulatory approvals and lifecycle management. Led regulatory submissions of observational studies to FDA and EMA, contributing to label updates and evidence packages supporting access decisions. Shaped pivotal trial design by partnering with Clinical Development on Phase II/III programs in bleeding disorders, co-leading regulatory interactions on trial methodology and external control arms. Oversaw real-world registries and external collaborations with academic centers and patient organizations, enhancing data quality and strengthening payer/reimbursement dossiers. Published 25+ abstracts and manuscripts, presented at major congresses, and led RWE due diligence for business development and M&A assessments.
Develop and execute global RWE strategy for CAR-T therapies in malignant hematology, aligning Phase II–IV observational studies with regulatory, clinical, and commercial objectives across ex-US markets. Serve as study director for post-marketing regulatory commitment studies, delivering on-time and on-budget evidence packages that supported label updates and submissions to EMA and other health authorities. Influence early development by integrating burden-of-disease, natural history, and epidemiologic insights into pipeline decision-making and trial design. Lead and mentor a high-performing team of epidemiologists, fostering expertise in study design, regulatory engagement, and RWE analytics. Collaborate cross-functionally with Clinical Development, Regulatory Affairs, Safety, Market Access, and CROs to embed RWE across the full product lifecycle.