Switzerland
Strategic clinical operations leader with over 20 years of experience delivering global trials across large pharmaceutical organizations and emerging biotech environments. Proven track record of accelerating clinical development timelines through innovative patient recruitment strategies and high-performing CRO partnerships. Extensive experience leading end-to-end operational strategy across all phases of development, with therapeutic expertise spanning endocrine, cardiovascular, oncology, rare diseases, immunology, and CNS. Recognized for building and mentoring high-performing global teams and embedding operational excellence across complex, multi-regional programs. Strong focus on governance, risk management, and cross-functional alignment to ensure delivery of high-quality studies on time and within budget. Deep expertise in vendor oversight, financial accountability, and global regulatory compliance, including ICH-GCP, FDA, and EU requirements.
Accelerated a complex Phase III oncology trial by implementing targeted recruitment strategies, achieving full enrollment one year ahead of schedule and enabling early database lock Led the turnaround of multiple underperforming clinical studies, stabilizing operations, mitigating risks, and restoring delivery against timelines and quality expectations Spearheaded the development and global implementation of a standardized clinical study transfer process, strengthening compliance, documentation quality, and operational consistency across Development Operations Provided strategic oversight of global CROs and vendors, optimizing performance, strengthening governance, and ensuring delivery excellence across complex, multi-regional clinical programs
Led the development of a new process impacting all of Global Trial Management to ensure compliance and study efficiency Senior Global Study Leader for complex Phase II/III oncology studies with complete responsibility for all deliverables SME and process improvement expertise Responsible for matrix management of teams including country study managers. Management of multiple vendors Mentoring of study managers Budget management
Led all Clinical Operations activities for a biotechnology startup in Basel, establishing operational processes and developing the company's Quality Management System (QMS) to support clinical development and regulatory compliance. Directed vendor strategy and oversight, managing the full RFP process, vendor selection, contracting, and ongoing performance management across multiple external partners and CROs. Successfully delivered Phase I and Phase II clinical trials within challenging timelines, ensuring high-quality execution, regulatory compliance, and effective cross-functional collaboration. Led the development and implementation of a novel electronic Patient-Reported Outcomes (ePRO) mobile application, overseeing vendor selection, technology transfer, validation activities, and preparation of regulatory documentation submitted to the FDA. Managed clinical trial budgets and financial oversight, including forecasting, contract management, invoice review, and approval processes to ensure efficient use of resources. Fostered strong partnerships with patients, investigators, vendors, and cross-functional stakeholders to optimize study execution, enhance patient engagement and retention, and support the successful delivery of clinical development programs.
Clinical Trial Leader for studies in Immunology (responsible for both scientific and operational aspects) including multi-country trials. Responsible for leading and matrix managing the multidisciplinary project team and support functions to ensure all trial deliverables are met according to timelines, budget, quality standards and operational best practices
Global Study Manager on a Phase III Immuno-Oncology study. Responsible for managing global sites across APAC and Europe. Responsible for setting up global recruitment workshops and presenting to investigators. Global travel including setting up and presenting at workshops, investigator meetings etc. Manage vendors including central labs and bio marker testing including contracts and budgets. Management of country study managers to ensure milestones were met.
Contract senior clinical study manager managing both the operations and scientific aspects of complex clinical trials