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DrJude O’Donnell

Global Head of Regulatory Strategy

Almac Diagnostic Services

 

 Current Role:

Dr O’Donnell is responsible for regulatory compliance for the development, validation and use of in vitro diagnostic devices within Almac Diagnostic Services. Since joining Almac Diagnostic Services, Dr O’Donnell has acted as Team Leader and Program Manager for the development and validation of a series of in vitro diagnostic clinical trial and companion diagnostic assays on behalf of Almac and Almac’s global pharmaceutical and biotechnology partners. Based upon the experience gained in these roles, her understanding of the entire diagnostic product life cycle and her experience leading interactions with regulatory bodies such as the FDA, Jude was appointed Head of Regulatory Strategy within Almac Diagnostic Services in 2019.

Previous Experience:

Prior to joining Almac Diagnostic Services, Dr O’Donnell obtained a PhD in molecular oncology from Trinity College Dublin and subsequently completed a postdoctoral fellowship on the role of BRCA1 in chemotherapy response at Queen’s University Belfast. 

Joined Almac:

2006

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