Senior Clinical Process Design & Strategy Leader

Digitailor; Chicago (IL); On-site; USD 180,000 - 230,000; Full time

Job summary

AbbVie is seeking an Associate Director, Clinical Process Engineer to own and evolve the clinical process engineering capability within Clinical Development Operations. The role defines methodology, standards, and governance to enable scalable, inspection-ready processes across AbbVie’s enterprise.

You will shape how the discipline works, build infrastructure, and lead enterprise-level programs with executive presence.

Qualifications

• Bachelor's degree in engineering, life sciences, business, or related field required; advanced degree strongly preferred.
• Lean Six Sigma Black Belt or equivalent preferred; Green Belt required.
• Minimum 8 years of demonstrated experience in process design, process engineering, and/or process improvement within a regulated environment (GxP, clinical development, quality systems, or similar).
• Deep expertise in clinical development operations and regulatory, inspection, and quality frameworks.
• Expert proficiency in process mapping, methodology development, and governance design; ability to scale capabilities in a large, regulated organization.
• Proven ability to lead enterprise-level, multi-stakeholder programs with executive presence and facilitation skills.

Responsibilities

• Define and own the clinical process engineering methodology, standards, and tools across Clinical Development Operations.
• Advise senior leadership on process strategy, capability investments, and cross-functional architecture.
• Oversee end-to-end clinical processes ensuring coherence, scalability and inspection readiness.
• Lead enterprise-wide process workshops and governance forums with high-stakes stakeholdership.
• Establish process compliance, inspection readiness, and quality-by-design frameworks.
• Lead cross-enterprise programs and governance, managing risk and stakeholder alignment.

Skills

Process mapping

Governance design

Executive presence

Strategic thinking

Stakeholder facilitation

Education

Bachelor's degree in engineering, life sciences, business, or related field

Job description

AbbVie is seeking an Associate Director, Clinical Process Engineer to own and evolve the clinical process engineering capability within Clinical Development Operations. The role defines methodology, standards, and governance to enable scalable, inspection-ready processes across AbbVie’s enterprise.

You will shape how the discipline works, build infrastructure, and lead enterprise-level programs with executive presence.