Advising and supporting Biotech and Pharmaceutical Companies in the areas of:

• Clinical Operations and Clinical Development
• Setup and improvement of Standard Operating Procedures (SOPs) and clinical work processes 

• Leading and organizing the operational part of the clinical development strategy and the implementation of the program of a novel COVID-19 vaccine
• Managing the collaborations with external partners including, e.g., Clinical Research Organizations (CROs) for clinical trial management, consultants, as well as vendors for eDiary, Interactive Response Technology, Central Laboratory, drug supply, covering selection, contract set-up and oversight
• Development and review of clinical SOPs 

• Set-up and heading the global clinical operations team including staff and budget responsibility (18 members)
• Development of the clinical operational strategy of various biological products and implementation and project management of the respective international clinical trials
• Selection, steering of and close cooperation with CROs and other vendors
• Continuous improvement of clinical-related SOPs and work processes

• Development of medical component of brand strategies. Creating, implementing and maintaining regional medical plan for assigned products in oncology and inflammatory diseases
• Preparing and implementing KOL network, patient and other stakeholder engagement plans
• Supporting marketing and market access strategies as cross-functional team member

• Building up and leading the department of Biosimilars Clinical Operations, planning and control of departmental budget
• Management of global clinical trials for various Biosimilars programs (Oncology, inflammatory diseases)
• Close cooperation with a CRO within a strategic partnership as well as with other development partners
• Coordination of the clinical activities between different sites and functions

• Development, implementation and management of the clinical operational program covering a global oncology product in preparation of application for market authorization (trials of phase I ? III with up to 200 trial sites in 25 countries) within budget, timelines and quality. Indications: Glioblastoma (GBM, incl. biomarker selection), Lung Cancer (NSCLC), Head and Neck Cancer (SCCHN)
• Leading and driving a multi-functional and global team; representation of Clinical Operations in the interdisciplinary program team; reporting and presentation towards decision committees of upper and top management
• Steering of and close collaboration with CROs

• Steering the operational execution of a clinical development program in different oncology indications (GBM, NSCLC, SCCHN), including successful management of budget, resources and timelines
• Close cooperation with CROs in the implementation and execution of the clinical program

• Management and coordination of various important work packages within a clinical Phase II study in the indication NSCLC with 40 centers in 8 countries
• Deputy of Global Clinical Program Manager for an oncology program

• Preparation, supervision and monitoring of clinical studies of Phase I and II in Europe and Russia, steering and supervision of CROs
• Regulatory coordination of projects, incl. contact with authorities (EMA, BfArM, DKMA, FDA) and preparation of the required documentation (CTA submission, IMPD, OMPD/ODD-reports, IND etc.)
• Coordination of collaborations with external partners, including coordination of GMP manufacturing processes and organization of clinical drug supply
• Heading the clinical operational unit of the TopoTarget group in Germany incl. staff responsibility (3 employees)

• Project management R&D, responsible for external collaborations, e.g. supervision of regulatory required GLP toxicology studies, coordination of clinical drug supply (GMP production) etc.
• Preparation and supervision of clinical studies in oncology and inflammatory disorders
• Co-operation in registration activities (amongst others OMPD, ODD, IND)
• Management of preclinical projects, including optimisation of recombinant protein therapeutic agents and their expression systems according to regulatory requirements