Germany
- Seasoned pharmaceutical leader with 22 years industry and management/leadership experience in drug development - part time freelancer - looking for opportunities to support small biotechs in early clinical development and strategy in the areas of infectious disease, critical care and oncology - Board-certified anesthesiologist and critical care specialist - Impacting the corporate/global strategy, performance and profitability of the respective therapeutic area via strategy development and execution, portfolio management, clinical development strategy, effective orchestration of global project management, steering of operational activities and priorisation - Substantial experience in pharmaceutical industry including research, pre-clinical development, all stages of clinical development (oncology, immunology, infectious disease), medical affairs as well as registration, launch and post-launch activities - Member of the TA Inflammation Leadership Committee representing Global Development - Broad therapeutic area knowledge including oncology, immunology and infectious diseases: Lung cancer, GI Cancers, Gynecological Cancers, Hematology; Inflammatory lung diseases, Sclerodermia, inflammatory bowel disease, Rheumatoid Arthritis, Psoriasis - Responsible for clinical development portfolio in Oncology until late 2020, with very broad pipeline and substantial number of 1st in-class projects (ranging from cell-direct therapies, Immuno-Oncology and combinations thereof, RNA-based anticancer vaccination , peptide/protein-based vaccination technology and oncolytic viral projects) - Successfully moving drug development projects through all phase development stages - Experience working collaboratively with key external therapeutic area experts/organizations on a global scale (USA, Japan, China) - Leadership experience in strategy development, line management, matrix environment, priorisation activities and change management - Collaborative and proactive leadership style, innovator, guiding diverse project teams across all phases of clinical development, including launch - Entrepreneurial attitude with passion for patient centricity, customer value delivery and a consistent history of exceeding expectations. Proven track record to lead and inspire a team of dedicated, highly motivated and qualified senior executive directors, including career development of direct reports - Skillful presenter with excellent communication skills, including successful requests for substantial investments FDA, EMA, PEI interaction FDA/EMA approval
Member of the Therapeutic Area Leadership Committee (TALC) representing Global Development. Full responsibility in shaping the portfolio and the strategic directions of the TALC. Member of the Development Committee of the TA Inflammation o Actively contributes to the development of the TA strategy and the TA portfolio with a focus on nonclinical development related aspects. Ensures that nonclinical development interests are appropriately considered. Has full overview on TA project portfolio. o BI´s Inflammation portfolio currently consist of multiple NME´s including NCEs, NBEs and ATMPs from pre-clinical to various Phases of clinical development and launched products (OFEV®) o Main disease focus in inflammatory lung disease (IPF/ILD), sclerodermia (SSc) and inflammatory bowel diseases (IBD, Crohn´s Disease, UC) o Translates respective needs between TALC functions and Global Development into technical and operational proposals thus driving innovative solutions and development concepts beyond individual project tasks. o Advise the TALC about technical and operational feasibilities, existing areas of expertise, relevant technologies or recent innovations with potential value for the pipeline portfolio or the TA strategy in general. o Drives the elaboration of TA specific non-clinical development concepts in order to support fast and innovative clinical development. o Promotes awareness and understanding of the TA strategy within Global Development