AbbVie is currently offering a unique opportunity for a highly motivated individual to join our team as a
Companion Diagnostics Operations Manager. We are seeking a creative and highly motivated scientist to join
the Companion Diagnostics Operations Group within the Companion Diagnostics Center of Excellence (CDx
COE), which supports CDx development across Abbvie. This group is responsible for the oversight and
execution of CDx development. The CDx Operations Manager will facilitate science-based CDx decision making, maintaining focus on innovative products and new diagnostic partners and technologies. The successful candidate will have experience synthesizing and facilitating key discussions on therapeutic product
and CDx co-development, project strategy, scenario planning, valuation, and cost.
- Drive the implementation of the clinical diagnostic strategy for therapeutic programs in early and late stage oncology clinical development.
- Lead and coordinate resources from multiple functional areas (Biomarker research, Regulatory, Pathology,
- Clinical Science, Bio sample 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.
- The liaison for CDx and external CROs, oversee the CRO/diagnostic partnering transfer activities with
- functional area leads.
- Oversee implementation of clinical trial assays at reference labs and centralized testing vendors.Monitors 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 timelines.
- Demonstrates a high level of outsourcing and technical competencies across multiple contract types and therapeutic/functional areas. Highly competent in negotiation and contracting business standards. Acts
- as the first line contact for issue escalation related to contracts
- BS or equivalent education and extensive, typically 7+ years of relevant experience; MS or equivalent
- education with typically 3+ years of relevant experience; PhD with typically 1+ years of relevant experience.
- Must have CDx expertise in oncology
- Experience with the discovery, characterization, clinical validation and launch of companion diagnostics
- Experience in development, outsourcing and validation of clinically applicable BM and CDx assays
- 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.