Dr. Josefin-Beate Holz

Global management function. Responsibility for LEO Pharmaceuticals R&D portfolio of small molecule products for the treatment of patients with skin diseases (e.g. psoriasis, skin infection, actinic keratosis, eczema, atopic dermatitis).

Executive management function. Build and lead company’s development operations of new biological entities (non-clinical and clinical) in inflammation, immunology, oncology and thrombosis. Advance discovery/ research lead candidates into early clinical development with focus on translational research and facilitate external partnering.

Executive management function. Head of preclinical research and development. Advanced monoclonal antibody research candidates (oncology) to pre-clinical and early clinical development stages utilising partnership/outsourcing model. Build “virtual” development organisation with network of international development professionals spanning non-clinical development, clinical/regulatory and manufacturing for monoclonal antibodies.

Senior management function. Clinical program director and head of interdisciplinary clinical project team late stage development (phase 3 and MAA submission). Clinical leadership of pivotal Phase 3 study. Authorship of study reports, integrated summaries (safety and efficacy), clinical section, risk analysis and safety management plan in MAA. Management of clinical advisory boards, key opinion leaders, clinical research organisations, academic research sites and translational research centres.

Senior management function. Medical marketing director for marketed products. Leadership of interdisciplinary national medical marketing team (sales force, product management, clinical research and study monitoring, safety monitoring and study analysis including biostatistics and data management). Conduct of phase 3b/phase 4 clinical studies on national and international level in life cycle management.

Late stage clinical development (registration and post approval) of oncology portfolio. Responsible for phase 3b and phase 4 studies for BMS oncology portfolio in Germany. Clinical lead for international phase 3b study leading to approval in this indication. Development of national and international clinical collaborations and working groups.

PhD Research activities: Development of a limited sampling model for drug monitoring of etoposide phosphate and introduction of clinical correlation model for PK and PD relationship with toxicity and response.