Preclinical Development Director & Intellectual Property Manager
Member of the Board of Directors, reporting to the company CEOPreclinical development global responsibilities: • Managing non-clinical development strategy for innovative therapeutic candidates through different stages of development (recombinant proteins, glycolipids) • Designing and managing GLP and non-GLP non-clinical drug development• Coordinating all related activities (costs, timing, and risk management) and direct overview & management of outsourced activities (CROs, academic collaborations) • Preparing key project documentation for Regulatory submissions (INDs in Europe, America, Asia, South Africa) and maintaining update knowledge of EMA, FDA and ICH guidance's and regulatory requirementsAchieved non-clinical development program for recombinant Interleukin-7 up to phase II and for Alpha-C-galactosyl Ceramide to early stage, 9 publications in international reviews Legal department (I.P. & Contracts) responsibilities: - Intellectual Property: • Managed Patent portfolio and provided strategic decisions for patenting• Performed prior art searches, oversaw competing patent survey and patents analysis• Worked collaboratively with patent attorney to respond to office actionsCo-inventor of 3 patents on Interleukin-7 among which 2 main patents granted worldwide- Contracts:• Managed R&D Contract portfolio until contract close-out• Prepared proposals, reviewed, negotiated and managed contracts (CDA, MTA, CTA, licensing contracts) in line with company strategic objectives and project requirements• Worked with the company senior management team and proactively engaged Clinical, Regulatory, Manufacturing and Business Development teamsWin-win approach, worldwide activity, Resolve disputes (100% amiable)Work independently and as part of a team with rapidly changing deadlines and priorities
