Experienced Clinical Science Consultant - Pharma & Biotech

12/2017 – 5/2020

• Provide state of the art scientific input to strategy planning, and for evaluation and interpretation of pre-clinical and clinical data
• Assist and complement the Director Clinical Sciences in assuring Sponsor's responsibilites in terms of medical/scientific due diligence according to current regulations
• Support, coordinate and manage interaction and collaboration with international/external stakeholders and vendors
• Development of and scientific support on clinical development plan, study protocol, investigator's brochure, clinical study report and other relevant documents for development and execution of clinical studies
• Scientific and in person support for meetings and workshops with investigators, consultants and monitors
• Provide training and scientific input to clinical operation’s colleagues and prinicipal investogators, site staff, and serve as trouble-shooter and expert on clinical and scientific support for medical issues and aspects of assigned studies
• Scientific support for study reports and preparation of materials for use in presentations and advisory committee meetings, and provision of response to regulatory agency questions
• Scientific support of business development; co-ordination, preparation, and review of study results for publications, abstracts, poster presentations and scientific meetings

Angewandte Forschung, Klinische Forschung, Projekt-Qualitätssicherung

9/2012 – 11/2017

• Management of clinical trials including study budget management and identifying, assessing and contracting suppliers of central pharmacy and regional lab services
• Organizational and in-time planning including monitoring of projects and project courses with the departments of PAREXEL and external units, as well as realization of management decisions
• Close communication with sponsors and stakeholders, conduct of project related meetings
• Manage international teams for the design and development of tailored clinical trial application including tracking, analysis and data export applications, and associated validation
• Lead cross-functional study teams to deliver services in time and budget
• Monitoring and organization of study performance taking into consideration national and international guidelines (AMG, GCP, FDA regulations, ICH-guidelines)
• Manage internal and external stakeholders (e.g., clients, KOLs, study sites)

Klinische Forschung, Projekt-Qualitätssicherung, Projektdurchführung, Projektmanagement

12/2008 – 12/2011

• Management and coordination of translational/early phase trials, including “Isolation of untouched regulatory T cells” for the treatment of GvHD in a phase I/II clinical trial
• Setup of protocol for isolation and adoptive transfer of human regulatory T cells for clinical application, SOPs and quality assurance
• Coordinating the project in cooperation and liaison with the pre-clinical development platform at SIgN, research companies, clinicians and authorities
• Conduct several research projects in human immunology, molecular genetics and oncology
• Training and supervision of students and Ph.D. students

Angewandte Forschung, Forschung & Entwicklung, Klinische Forschung