Associate Director, Clinical Process Engineer

Job Description

Purpose statement

Own and evolve the clinical process engineering capability within Clinical Development Operations, establishing the methodology, standards, and governance infrastructure that enable scalable, inspection-ready, and operationally excellent processes across the enterprise. The Associate Director, Clinical Process Engineer is the functional authority on process design and engineering practice, operating at the intersection of strategy, compliance, and execution. This role shapes how the discipline works, not just what it delivers, and is accountable for building the infrastructure and talent that sustains the capability long-term. Operates within a multilayered leadership structure and is expected to bring enterprise-level judgment and strong upward credibility.

Major responsibilities

1. Define and own the clinical process engineering methodology, standards, and toolset used across Clinical Development Operations; drive adoption and continuous evolution of the practice.
2. Serve as the enterprise subject matter authority on clinical process design, advising senior and executive leadership on process strategy, capability investments, and cross-functional process architecture.
3. Oversee the design and governance of end-to-end clinical processes across the enterprise; ensure coherence, scalability, and inspection readiness across domains and programs.
4. Lead enterprise-level current-state assessments and strategic process analyses; translate findings into capability recommendations and program-level improvement roadmaps for executive audiences.
5. Design and lead high-stakes, enterprise-wide process workshops and governance forums; manage executive-level stakeholder dynamics, resolve competing priorities, and drive strategic alignment.
6. Establish and own the process compliance, inspection readiness, and quality-by-design frameworks for the function; proactively manage risk and partner with quality and regulatory leadership on emerging expectations.
7. Lead and govern complex, cross-enterprise process-to-system programs; accountable for the quality and integrity of process design inputs feeding technology platforms and transformation initiatives.
8. Own the process performance measurement framework for the function; define enterprise KPIs, oversee reporting infrastructure, and present insights to senior leadership and governance bodies.
9. Set and govern documentation standards, decision record practices, and process governance infrastructure across Clinical Development Operations; responsible for audit readiness at a function-wide level.
10. May manage 0–5 direct reports; responsible for team leadership, talent strategy, performance management, and building a differentiated, high-impact process engineering capability.

Qualifications

• Bachelor's degree in engineering, life sciences, business, or a 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), with progressively increasing scope and complexity.
• Deep expertise in clinical development operations and regulatory, inspection, and quality frameworks, including the ability to advise senior leadership on emerging compliance expectations.
• Expert proficiency in process mapping, methodology development, and governance design; demonstrated experience building and scaling process engineering capabilities within a large, regulated organization.
• Proven ability to lead enterprise-level, multi-stakeholder programs and governance forums with executive presence and strong facilitation skills.
• Strategic analytical skills; ability to synthesize complex, multi-variable environments into executive-ready insights and capability recommendations.
• Demonstrated experience leading large-scale process-to-system transformation programs, including stakeholder alignment, risk management, and program governance.
• Exceptional written and verbal communication skills; experienced presenter to senior and executive leadership.
• Proven track record of leading high-performing teams, building capability, and operating with enterprise-level judgment in a complex, matrixed, global organization.

Key stakeholders

• BPOs, Process Experts, and functional senior leadership.
• Clinical Development Operations executive leadership and governance bodies.
• Process Excellence leadership, process architects, and enterprise governance leads.
• Quality, compliance, regulatory, and inspection readiness leadership.
• Change, learning, and transformation leadership.
• Technology and digital platform leadership.
• Cross-functional program leadership, governance forums, and enterprise initiative sponsors.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

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