Clinical Diagnostic Operations Manager

3 days ago

Watertown, Massachusetts, United States AbbVie Full time
About the Role

Absorb the opportunity to lead the implementation of clinical diagnostic strategies for therapeutic programs in early and late stage oncology clinical development at AbbVie.

This role requires a highly motivated individual to 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.

Key Responsibilities
  • Drive the implementation of clinical diagnostic strategies for therapeutic programs in early and late stage oncology clinical development.
  • Lead and coordinate resources from multiple functional areas, including Biomarker research, Regulatory, Pathology, Clinical Science, Biosample Management, Clinical Operations, and Medical Affairs.
  • Manage activities and tech transfers across various AbbVie sites for CDx programs and understand cost drivers associated with contract types and drive negotiations that ensure the best value for quality, pricing, and service.
  • Oversee the liaison for CDx and external CROs, and oversee the CRO/diagnostic partnering transfer activities with functional area leads.
  • Oversee the implementation of clinical trial assays at reference labs and centralized testing vendors, and monitor all changes in study scope ensuring timely finalization and implementation, including the negotiation of change order costs for impacted agreements.
  • Responsible for communication of status of negotiations with key internal and external stakeholders in a timely manner.
  • Accountable for all activities involving start-up execution and close-out of all contracts, budgets, and time-lines.
Requirements
  • BS or equivalent education and extensive, typically 5+ years of relevant experience; MS or equivalent education with typically 3+ years of relevant experience; PhD with typically 1+ years of relevant experience in pharmaceutical and/or diagnostics companies.
  • Experience managing Biomarker and/or CDx aspects of early and late stage clinical programs, including sample management, working with CROs and Diagnostic partners.
  • Experience managing budgets, creating RFP/RFIs, and reviewing proposals/contracts from external vendors.
  • Experience with the development and validation of clinically applicable diagnostic assays, and/or clinical validation and launch of companion diagnostics.
  • Excellent verbal communication and interpersonal skills are required.
  • Strong motivation, attention to detail, ability to think independently, and fully integrate into a high-achieving team environment.
About AbbVie

AbbVie is a global biopharmaceutical company that discovers and delivers innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.

We strive to have a remarkable impact on people's lives across several key therapeutic areas, including immunology, oncology, neuroscience, and eye care, and products and services in our Allergan Aesthetics portfolio.

For more information about AbbVie, please visit our website.

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