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Manager, Companion Diagnostic Operations


This is a Contract position in South San Francisco, CA posted June 11, 2020.

About AbbVie AbbVie (NYSE:ABBV) is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions.

The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience.

In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world.

For more information about AbbVie, please visit us at .

Follow abbvie on Twitter, Facebook or LinkedIn .

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.

Responsibilities : 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 Qualifications 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.

Significant Work Activities N/A Travel No Job Type Experienced Schedule Full-time Job Level Code M Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients.

As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.