A global-leading, pharmaceutical organization is looking to add to its growing Medical Affairs team, with an opening for a Senior Medical Director. The Senior Medical Director will report directly into the Vice President of US Medical Affairs in a crucial leadership position.
Location: Boston, MA.
Responsibilities
-Will drive strategy for the global clinical development, taking into consideration the medical, regulatory, and commercial issues for allocated company pipeline.
-Drives Development Team strategy producing the Development Strategy, Clinical Development Plan and Clinical Protocols.
-Accountable for high impact global decisions: monitoring and deciphering data from internal and external studies, assessing the medical and scientific implications.
-Responsible for medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety.
Requirements
-MD or internationally recognized equivalent plus 5 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia.
-NDA/MAA/Submission experience
-Experience leading a clinical development team with responsibility for studies in multiple regions.
-Rare Diseases Experience preferred.