Director II, Biomarker and Sample Operations

Company 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 www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

At AbbVie, we are redefining the future of medicine-harnessing the power of Precision Medicine to deliver breakthrough therapies tailored to individual patients. As the Director of Biomarker and Sample Operations, you will be at the forefront of this mission, leading a team that drives biomarker integration into clinical trials and shaping the future of Medicine. In this role, you will set the vision for Biomarker Operations, optimize processes, and expand operational capabilities to enhance biomarker-driven clinical development. You will work cross-functionally to drive innovation, influence global drug development strategies, and ensure that AbbVie remains a leader in precision-driven drug development.

Leadership & Strategy:

• Lead with vision-mentoring and empowering a high-performing team of Biomarker Program Managers and Sample Operations Managers.
• Foster a culture of accountability, innovation, and continuous improvement, ensuring AbbVie's leadership in biomarker-driven drug development.
• Define and execute a strategic roadmap for Biomarker and Sample Operations, ensuring alignment with AbbVie's long-term Precision Medicine goals.

Precision Medicine Integration & Clinical Operations:

• Oversee the seamless integration of biomarkers into clinical trials, ensuring precision-driven strategies enhance patient outcomes.
• Manage biomarker operations and logistics to support clinical trial timelines, optimizing efficiency and resource utilization.
• Proactively identify, mitigate, and resolve biomarker study-related risks, ensuring regulatory and informed-consent compliance, and operational excellence.
• Drive strong alignment between BPM and CDx Operations by developing a cohesive strategy that optimizes workflows, enhances collaboration, and supports successful integration of biomarkers and companion diagnostics into clinical programs.

Innovation & Expansion of Biomarker Capabilities:

• Leverage AI-driven technologies to optimize biomarker operations, enhancing process efficiencies, data analyses, and decision-making to improve sample management, vendor oversight, and trial execution.
• Develop scalable and future-ready operational models that support biomarker-driven clinical development across AbbVie's pipeline.

Vendor & Budget Management:

• Oversee vendor selection, contract execution, and ongoing performance management, ensuring compliance with AbbVie's standards.
• Manage internal and external budgets for therapeutic areas and companion diagnostics, providing accurate financial projections on a monthly, quarterly, and annual basis.

Cross-functional Collaboration & Influence:

• Influence and align cross-functional teams-including Clinical Development Operations, Regulatory, Procurement, and Finance-to create and execute a coherent Precision Medicine strategy.
• Develop operational infrastructure that ensures biomarker integration is seamless, scalable, and drives long-term success in AbbVie's clinical programs.
• Act as a strategic advisor, engaging with senior leadership to drive decision-making and remove roadblocks to execution.

Portfolio & Program Management:

• Contribute to portfolio planning, developing cost, resource, and timeline projections for biomarker-driven clinical development programs.
• Lead high-impact, transformational projects with significant organizational influence, ensuring effective execution of strategic priorities.
• Champion change management initiatives, ensuring cross-functional adoption of best practices in biomarker operations.

Talent Development & Organizational Growth:

• Develop, mentor, and empower Precision Medicine operations staff, fostering a pipeline of future leaders within the organization.

Champion a culture of continuous learning and professional growth, providing opportunities for team members to expand their expertise and leadership skills.

Qualifications

• Bachelor's Degree in sciences or equivalent with relevant experience required, advanced degree preferred.
• At least 15 years in Pharma, biomarker/CDx, and clinical research demonstrating a high level of core, technical, and leadership competencies through setting and driving study strategy and leading a global team in the management and completion of multiple clinical studies.
• Proven track recorded of leading successful biomarker/CDx development and clinical programs.
• Strong experience in risk management, decision-making, and strategic execution and a fast-paced environment managing multiple priorities effectively.
• Demonstrated ability to innovate and drive change in a large, matrixed organization.
• Proven experience in leading, mentoring and developing direct reports, and fostering a collaborative and high-performance team environment.
• Considered a subject matter expert for standard business and operating procedures, initiatives and advancement of biomarker and CDx operations.
• Participation in a regulatory submission is preferred.

Additional Information

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 pay is considered to be wages 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 Company's sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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