Work cross-functionally to ensure project team deliverables
Provide scientific leadership to research project team and scientifically support the clinical study team
Responsible for the non-clinical content of all clinical and regulatory documents and the scientific accuracy of study-related documents.
Participate in the development of manufacturing processes and control strategy in cell & gene therapy
Project Leader, in: 1- developing a cell & gene therapy product up to the successful application of a CTD for marketing authorization in EU (Zalmoxis, MolMed); 2- the successful submission of a CTA dossier in EU Countries for a new cell & gene therapy product in oncology (CD44v6.CAR T, MolMed).
Interaction with external advisors, key opinion leaders and regulatory authorities (EMA, AIFA, PEI, SUKL, AEMPS)
Coordination of European and national funded research projects.
Management of the Research Department’s team, budget and investments
Responsible for the design and implementation of research studies in cancer
Contribute to several translational research studies in cancer