This position serves as a key role in the effective implementation of the global development strategy leading or co-leading one or more clinical trials in a therapeutic area for one or more compounds in various stages of clinical development (including
You will play a key part in driving operational excellence, ensuring compliance, and enabling seamless execution of strategic initiatives - from managing external events and vendor relationships to supporting budgeting processes and global collaboration.
Responsible for leading and coordinating operational activities supporting clinical stage development programs within CNS and rare disease indications, ensuring alignment across clinical supply, external manufacturing, quality coordination and vendor
Develop and execute robust global regulatory CMC strategies for marketed biological products throughout their lifecycle. Plan, review, and prepare CMC documentation for marketing authorization maintenance, post-approval variations, and health authority