Jutta Hofmann
Global Clinical Program Director @CSL
Signup · Get unlimited contacts
WORK HISTORY
Global Clinical Program Director @CSL
Responsible for concept development and design of clinical trials to integrate the clinical strategy into the overall clinical development plan in various immune deficient and autoimmune conditions; clinical project planning and operational execution (including vendor selection and budget planning), and development of key trial-related documents (eg, clinical study protocol, medical monitoring plan)• Leading cross-functional clinical development teams responsible for generation and maintenance of a scientifically sound clinical development plan aligned with regulatory and commercial strategies• Acting as the primary clinical representative on safety/risk management teams.• Acting as clinical subject matter expert to support regulatory interactions, including development of regulatory dossiers, meeting requests, inspections, IND and CTA filings• Identifying and collaborating with respective Key Opinion Leaders in the field – selection of KOLs for study-related committees and advisory boards, interaction for publications• Acting as Medical Monitor for global late-stage clinical trials – responsible for medical oversight
EDUCATION
Justus Liebig University Giessen
State examination, Human medicine
SKILLS
ABOUT JUTTA HOFMANN
High performing Clinical Development professional with 9+ years comprehensive global working experience in the pharmaceutical industry (US, Switzerland, Germany) and physician background; managing diverse, international, cross-functional teams; confidently navigating matrix environments across geographies and cultures. Experienced with global late-stage trials in Immunology (Phase in US, Canada, Europe, Switzerland, Japan, Australia.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.