Interim Project Leader

• Proven track record in leading successful transitions from pre-clinical to clinical development, demonstrating expertise in project and stakeholder management

• Expert in translational medicine and strategic leadership, with a focus on immunology, immune-oncology, dermatology, and regenerative medicine, providing innovative solutions to scientific challenges

• Strong communicator and strategic thinker with deep experience in drug development, offering expertise in regulatory document preparation, vendor management, and scientific consulting

• Extensive experience in clinical document writing and regulatory submissions

Led the establishment of Translational Science as a new function within a matrix organization. Managed late pre-clinical and clinical programs for innate cell engagers. Responsibilities included:

• Strategy for transition from pre-clinical to clinical development

• Biomarker planning, testing, and reporting

• Scientific contextualization of data

• Presentation at scientific conferences

• Prioritization of assays based on cost/benefit ratio

• Vendor management under GCP/GCLP

• Risk management and budget responsibility for about 10M/year

• Leadership of cross-functional teams

• Member of global project teams and internal decision boards

Led global project teams in Immunology, Dermatology, and Hepatology for early hepatology projects (NASH fibrosis), regenerative medicine, and non-melanoma skin cancer (clinical testing until Phase 2A). Responsibilities included:

• Collaborations with external KOL in clinical and preclinical research

• Head of a laboratory in immunology, dermatology, intestinal biology, hepatology, inflammation, and regenerative medicine

• Scientific support of pediatric approval study in bone metabolism (Ph4) and early clinical malaria projects (Ph2b)

• Compiler of IB updates, including revision of clinical sections

• Experience in clinical document writing (Protocols, CDP, etc.)

• Trainings in SOPs, ICH guidelines, Data management

Postdoctoral research position in the Department for Autoimmunity and Transplantation, focusing on psoriasis and atopic dermatitis.

Postdoctoral research position in the Institute for Immunology, focusing on homeostatic chemokine receptors in the lung. Research included:

• Migration of dendritic cells and lymphocytes

• Impact on the induction of asthma and maintenance of tolerance

• Funded by German Research Foundation (DFG) collaborative research centre ‘Immune reactions of the lung in infection and allergy’