Bio

Professional Experience: 20 years in drug development at Molecular Partners, Janssen/Covagen, Merck Serono, Micromet and Bavarian Nordic Track record marked products: BLINCYTO and JYNNEOS Key Areas of Expertise in drug development: Primary pharmacology, safety pharmacology, DMPK, toxicology, early clinical development and regulatory affairs Class of Molecules: CD3-redirecting T-cell engagers and CAR-T cell therapies, bi- and multispecific constructs, alternative binding scaffolds, mAbs & biosimilars, Fc-cytokine and HSA fusion proteins, peptide-based immunomodulators, therapeutic cancer vaccines & classical vaccines and some small molecules Skills and Knowledge: Nonclinical and early clinical development of biologics (in depth) and small molecules (some experience) according to international regulatory guidelines. Focus on immuno-oncology and inflammatory diseases Preparation of regulatory documents (e.g. IND/IMPD, IB, CTD, BLA/NDA), health authority interactions and advancing novel modalities and MoAs into the clinic. Evaluation of in-licensing opportunities and support of out-licensing. Selection, contract negotiation and oversight of CROs for IND-enabling studies. Initiation and supervision of academic collaborations Team leader of international and multidisciplinary project groups. Leadership, motivation, teamwork, problem solving/goal-oriented attitude and communication with impact Degree: PhD in Immunology at the University of Würzburg, Germany MSc in applied toxicology at the University of Surrey, Guildford, UK