BRUXELLES
I am an Italian Pharmacist with a PhD in Molecular and Cellular Pharmacology; I have been working in Clinical Research since 2005 and I did spend my last 5 years covering roles in International Management of Clinical Trials.
I spent many years in Clinical and Preclinical Research working with Pharma/Biotech companies, CRO and Academic institutions; these collaborations provided me a large background in CNS, Vaccines, Oncology and Cardiovascular, enhanced my attitude of leadership, optimize my effectiveness in taking decision, sharped my attention to timelines and performance under high quality standards.
Covering different roles (CRA, Med Affairs/Drug Safety/ Global Study Manager/Head of CPM) definitively allowed me to improve not only the execution of operational activities but also the coordination and communication at different levels and directions, the importance of sharing and learning from the experience, the consideration of people and their value, acceptance of critics for my personal and professional growth.
My experience with classical Investigational Medicinal Product (Ivabradine) and lately with Advanced Therapy Medicinal Product (Stem cells) or Vaccines in Cancer Immuno-therapeutics provided me a strong background in development of pharma products.
The involvement in Cardiovascular as well as in Oncology and Vaccines permitted to gain scientific and technical knowledge that could be relevant and applicable to Medical Devices field:
• difficult and elaborated protocols
• human samples use in clinical trial
• recruitment strategies
• Compassionate Use and Early Access Programs
• Targeted therapy in cancer (Antigene Specific Cancer Immuno-therapy)
• ethical aspects and critical discussion with CA and EC: use of stem cells, placebo control arm, invasive procedures per trial request, safety and rights of patients
• dealing with specific regulatory aspects in submission process, including ATMP
• cold chain control (for vaccines and stem cells)
• complicated reconstitution process at hospital for use of medicinal product
I judge probably in your interest my collaborations and coordination of trial involved entities located in other regions (Latin America, South Africa, Israel, Malaysia, Singapore, Russia and USA) and belonging to different institutions or companies, which permitted to face different mentalities and test the cultural diversity and build relationship at different level and with different functional teams.
I do have a deep rooted sense of responsibility that guides my search for high quality standard; my creativity is balanced by sense of rigor.
I'm positive but realistic and pragmatic; my ability to think out of the box is based on multiple experiences and learned lesson attitude. I carefully evaluate the risk and the different scenarios before to act.
People could say that I'm a good communicator, a fair leader and an attentive supervisor. I learned the importance of delegating and I'm used to share my knowledge.
I'm capable to deal with critical and difficult partners. I’m ready to change direction if the conditions impose it; “estote parati” always inspires me.
I prefer the PA (preventive actions) instead of CA (corrective actions), but I’m fully conscious that we cannot always prevent the possible issues.
Since I started my career my motivation is to get good medications and care available for patients.
Mes compétences :
Global Project Management- Clinical trial
Drug Safety-medical assessment and Reporting
