Vice President R&D Operations, Shareholder
Selection of CROs and academic labs, contracts negociations, and management of all external collaborations for R&D program, including discovery, regulatory toxicology, CMC, clinic. Whole activities representing close to 80 people located in EU, US, Asia. Selection and coordination of consultants activities.Discovery: Driving discovery efforts in the field of autoimmune disease, peptides synthesis, X-ray protein structure, virtual screening/docking, H2L screening cascade design, lead optimization.Toxicology: deeply involved in protocol and data discussions for full package studies up to 13 weeks studies and reprotox.CMC: coordination of programs from non-GMP to GMP batchs, including drug product formulation.Clinic: Coordination of regulatory submissions (IB, IMPD) for phase 1a and phase 1b/2a. Writing of clinical synopsis/protocol for clinical phase 1a, 1b and 2a. Key input in dose escalating schedule, PK interpretation and doses selection.Participation to data package for investors and participation to discussions.