Manager, Companion Diagnostic Operations - South San Francisco, United States - AbbVie

Description

AbbVie's mission is to discover and deliver 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 immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description

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.

Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Qualifications

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.
  
  
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• Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
  • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
    
    
  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
    
    
  • This job is eligible to participate in our short-term incentive programs.
    
    
  • This job is eligible to participate in our long-term incentive programs.
    
    
  • Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion, consistent with applicable law.
    Additional Information
    AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.