Switzerland
With over 10 years of clinical operational and development experience, I am a passionate leader and a strategic thinker who strives to deliver innovative and effective therapies for patients with rare diseases. As the Director Clinical Operations at Pharvaris, I oversee the planning, execution, and management of global clinical trials for novel oral treatments for hereditary angioedema. My core competencies include clinical project management, regulatory affairs, employee coaching, and cross-functional collaboration. I have successfully led multiple clinical programs from phase I to phase III, ensuring quality, compliance, and timeliness of deliverables. I have also contributed to the development and implementation of clinical operational strategies, policies, and best practices. In addition, I have mentored and supported a team of clinical operations professionals, fostering a culture of excellence, learning, and growth.
Phase I and Phase II - Global location with 120 Sites on Ulcerative Colitis Main Responsabilities include: Manage all operational aspects of global clinical studies from initial study concept to final report within the scope of the company's development plan Coordinate and oversee the development of study protocols, and cooperate in the development of other essential documents for clinical studies, providing expert scientific input throughout. Manage all required protocol amendments/deviations. Support evaluation, selection and management of Clinical Research Organizations. Obtain expert scientific/medical/regulatory input from external consultants at appropriate stages of development Give input at meetings and interactions with health authorities and in response to questions posed by health authorities and ethics committees/JAB's worldwide, where appropriate. Provide scientific input in the design and implementation of clinical development strategies and global clinical development plans Stay abreast of regulatory requirements and guidelines and current trends in the fields of products in development. Survey clinical program time lines, budgets, and strategies. Report issues, shortcomings, bottle necks where necessary to superiors and propose risk mitigation actions. Support cross-functional scientific team of internal and, if required, external stakeholders involved in the different phases of drug development Through the clinical development team, assure timely initiation and completion of studies ensuring high quality and credible data. Write and/or review clinical sections of clinical/statistical reports, including investigator's brochures, INDs and NDA, and other clinical trial and regulatory submissions.