Manager, Companion Diagnostic Operations

$103,500 - $197,000/Yr

AbbVie - Waltham, MA

Full-time - Mid Level

Waltham, MA

Chemical Manufacturing

About the position

The Manager, Companion Diagnostics Operations at AbbVie will play a crucial role in the Precision Medicine team, focusing on the development and execution of clinical diagnostic strategies for therapeutic programs in oncology. This position involves collaboration with various functional areas and external partners to ensure effective project management and resource coordination throughout the clinical development process.

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 including Biomarker research, Regulatory, Pathology, Clinical Science, Biosample Management, Clinical Operations, and Medical Affairs.
• Manage activities and tech transfers across various AbbVie sites for CDx programs, understanding cost drivers associated with contract types and driving negotiations for optimal value.
• Act as the liaison for CDx and external CROs, overseeing the CRO/diagnostic partnering transfer activities with functional area leads.
• Oversee implementation of clinical trial assays at reference labs and centralized testing vendors, monitoring changes in study scope and negotiating change order costs.
• Communicate the 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 contracts, budgets, and timelines, demonstrating high outsourcing and technical competencies.

Requirements

• BS or equivalent education with 5+ years of relevant experience; MS with 3+ years; or PhD with 1+ year of relevant experience in pharmaceutical and/or diagnostics companies.
• Experience managing Biomarker and/or CDx aspects of early and late stage clinical programs, including sample management and 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.
• Strong motivation, attention to detail, and ability to think independently.

Benefits

• Paid time off (vacation, holidays, sick)
• Medical, dental, and vision insurance
• 401(k) plan
• Short-term incentive programs
• Long-term incentive programs