Senior Manager, Operations

About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

AbbVie is currently offering a unique opportunity for a highly motivated individual to join our Precision Medicine team as a Companion Diagnostics Operations Senior Manager. The CDx Operations Senior Manager 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 CDx co-development, project management, scenario planning, budgeting, and managing external vendors and partners.

 

 

 

Responsibilities:

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

• 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.

 

 

 

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.

Qualifications

 

• BS or equivalent education and extensive, typically 7+ years of relevant experience; MS or equivalent education with typically 5+ years of relevant experience; PhD with typically 3+ years of relevant experience in pharmaceutical and/or diagnostics companies.
• Should have 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.

 

Key Stakeholders: Precision Medicine (CDx Strategy Leads), Pathology, Precision Medicine Leads), External Partners, Vendors and Finance

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 10 % of the Time
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.