I am a passionate drug development executive with over 20 years of extensive global clinical operations and clinical sciences experience in oncology, neurology, gastro-intestinal and metabolic orphan diseases at mid-size and start-up biotechnology companies; I have actively contributed to the registration of 3 medicinal products and led multiple investigational products from idea to phase II/III, overseeing all the clinical and regulatory operational activities. I have an in-depth knowledge of FDA/EMA regulations for GCP’s, GLP’s and GMP’s and experienced in establishing and developing clinical operations, regulatory affairs and quality assurance systems. I have strong management and leadership abilities and have led development operational teams up to 40 FTE, external consultants and global Clinical Research, Lab and Manufacturing Organizations in over 30 international phase I to IV clinical studies.
Special interests: operations excellence, innovation in clinical development operations