Companion Diagnostics Operations Director

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 team as a Director of Companion Diagnostics (CDx) Operations. This individual will be leading the Companion Diagnostics Operations Group within Precision Medicine to support the execution of CDx development strategy across Abbvie. The successful candidate will have extensive experience in facilitating key discussions on therapeutic product and CDx co-development, project management, scenario planning, contracting with external vendors, and managing budgets.

 

Responsibilities:

• Drive the execution of the global clinical diagnostic strategy for therapeutic programs in early and late stage clinical development
• Managing a team of operations managers supporting Biomarker/CDx programs
• Coordinate CDx operational activities with multiple functional areas (Biomarker research, Regulatory, Pathology, Clinical Science, Biosample Management, Clinical Operations and Medical Affairs)
• Manage activities and tech transfers to external labs
• Serve as the liaison for 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
• Manage contracts, budgets and timelines

Qualifications

• PhD preferred but not required.
• PhD with 7+ years of relevant experience in pharmaceutical and/or diagnostics companies. BS or equivalent education with 12+ years of relevant experience in pharmaceutical and/or diagnostics companies; MS or equivalent education with 10+ 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 a team providing support for biomarker and CDx programs
• Experience managing budgets, negotiating contracts with external vendors
• 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: CDx organization (CDx Strategy Leads, Precision Medicine Leads, Precision Medicine Pathology Team), External Vendors and finance

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 20 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
D
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.