Overview:
A well established preclinical-clinic program manager in my network has recently become available for 3 days per week to take on a new project, ideally they are looking to utilise thier regularory expertise and mRNA skills developed working on a preclinical asset they managed to get to phase 2, below is a snapshot of their profile:
- Over 25 year’s experience demonstrating leadership in drug development programs across oncology and rare indications using Gene therapy RNA, and mRNA
- Spearheaded the mRNA cancer vaccine for a pivotal phase 1 and 2 trial across 160 sites in 20 countries
- Coordinated all modules of EMA and FDA regulatory dossiers including IMPD, CTA, IND, MAA and NDA/BLA
- Led the development of 10-15 difference projects across AAV gene therapy products from preclinical to phase 2
- Contributed to a successful acquisition of a small biotech and large pharmer through management of due diligence processes and strategic coordination