+447836626543
Dr Jonathan Janes
MB BCh BSc FFPM FRCP
About
Experienced Senior Medical Director with a demonstrated history of success working in the pharmaceutical industry over 28 years. Skilled in global Pharmaceutical Development, providing pharmaceutical consulting, specialising in clinical development, regulatory interactions, and asset due diligence, focusing on immunology, dermatology, endocrinology, cardiovascular and critical care.
Key Activities and Experience
Asset due diligence for acquisition and internal commercial decision
Phase 2 and phase 3 global study design, implementation, data interpretation and study report completion
Regulatory strategy including
Regulatory interactions with FDA, EMA and PMDA
Regulatory submissions
Regulatory responses
Experience with both recombinant protein and small molecule development
Relevant experience with product launch and commercialisation
Broad range of therapeutic experience including immunology, dermatology, endocrinology, cardiovascular and critical care