Expertise in all aspects of drug development, registration (NDA), approval (FDA label negotiation) lunch and post-launch activities in the US. Responsibilities including: market/competitors evaluation and strategic/competitive clinical development planning; strategic decision making on study designs, implementation and reporting; medical affairs (core copy approval team member, publication strategy, clinical input to global and US Advisory Boards, responsible for establishing working relationship with experts) and market support (working with Brand team on all clinical aspects of the product strategy); US medical monitor for Phase IV studies.