Senior Manager, Companion Diagnostics Operations

Purpose:

AbbVie is currently offering a unique opportunity for a highly motivated individual to join our Precision Medicine team as a Manager II, Companion Diagnostics Operations. The CDx Operations Manager II will work closely with CDx Strategy Leads and other clinical development team members to facilitate science-based CDx decision making and support the execution of CDx development strategy for AbbVie programs across therapeutic areas. The successful candidate will have experience in facilitating therapeutic product and/or CDx co-development, project management, scenario planning, budgeting, and managing external vendors and partners.

Responsibilities:

• Drive the execution of the global clinical diagnostic strategy for therapeutic programs in early and late-stage clinical development
• Coordinate CDx operational activities with multiple functional areas (Biomarker Research, Regulatory, Pathology, Clinical Science, Biosample Management, Clinical Operations, and Medical Affairs)
• Serve as the liaison for CDx Partners and CROs.
• Oversee the CRO/diagnostic partnering transfer activities with functional area leads
• Manage activities and tech transfers across various AbbVie sites and CRO laboratories for CDx programs
• Oversee implementation of clinical trial assays at reference labs and centralized testing vendors
• Manage contracts, budgets and timelines.