Our Study Management Departments are part of global teams committed to bringing new therapies to patients in a variety of disease areas, including oncology, renal failure, osteoporosis and inflammatory diseases. We are responsible for planning and overseeing the cross-functional execution of global and regional clinical studies (phase 2-5) to enable initial licensing and subsequent lifecycle management of new medicines.

Our activities include: core membership of the Global Development Team, leadership of cross-functional Study teams, contribution to the writing and review of study documentation including protocols, initiation of study feasibility, selection of clinical investigators, management of study budgets, timelines and partners, data collection and analysis, as well as ensuring high quality and compliance with GCP (Good Clinical Practice) and Standard Operating Procedures (SOPs).

The Early Development Therapeutic Area provides an experienced management and monitoring resource for Amgen’s early phase studies. We are responsible for selecting and building effective working relationships with specialist Clinical Research Centres where such studies are conducted. Where possible, we work with these centres to initiate, develop and maintain relationships with Key Opinion Leaders (KOLs) who will be important for the later stages of development.

Early Development is a focal point for all regional study management activities, providing expert scientific and strategic advice on Phase 0 and Phase 1 opportunities.