Associate Director, Clinical Process Engineer
About The Position
The Associate Director, Clinical Process Engineer owns and evolves the clinical process engineering capability within Clinical Development Operations. The role establishes the methodology, standards, and governance infrastructure needed to support scalable, inspection-ready, operationally excellent processes across the enterprise. As the functional authority on process design and engineering practice, the position works at the intersection of strategy, compliance, and execution, shaping how the discipline operates and building the infrastructure and talent needed to sustain it. The role operates within a multilayered leadership structure and requires enterprise-level judgment and strong upward credibility. The position may manage 0–5 direct reports and is responsible for team leadership, talent strategy, performance management, and developing a differentiated process engineering capability. It works with functional and executive leadership, process and governance experts, quality and regulatory partners, technology leaders, and cross-functional program sponsors.
Requirements
- Bachelor's degree in engineering, life sciences, business, or a related field.
- Green Belt certification required.
- At least 8 years of demonstrated experience in process design, process engineering, and/or process improvement in a regulated environment, 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, with experience building and scaling process engineering capabilities in a large, regulated organization.
- Demonstrated ability to lead enterprise-level, multi-stakeholder programs and governance forums, with executive presence and strong facilitation skills.
- Strategic analytical skills and ability to synthesize complex environments into executive-ready insights and capability recommendations.
- Experience leading large-scale process-to-system transformation programs, including stakeholder alignment, risk management, and program governance.
- Exceptional written and verbal communication skills and experience presenting to senior and executive leadership.
- Track record of leading high-performing teams, building capability, and exercising enterprise-level judgment in a complex, matrixed, global organization.
Nice To Haves
- Advanced degree strongly preferred.
- Lean Six Sigma Black Belt or equivalent preferred.
Responsibilities
- Define and own clinical process engineering methodology, standards, and tools across Clinical Development Operations, and drive adoption and continuous improvement.
- 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.
- Oversee the design and governance of end-to-end clinical processes, ensuring coherence, scalability, and inspection readiness across domains and programs.
- Lead enterprise current-state assessments and strategic process analyses, translating findings into capability recommendations and improvement roadmaps for executive audiences.
- Design and lead enterprise-wide process workshops and governance forums, manage executive stakeholder dynamics, resolve competing priorities, and drive strategic alignment.
- Establish and own process compliance, inspection readiness, and quality-by-design frameworks; proactively manage risk and partner with quality and regulatory leadership on emerging expectations.
- Lead and govern complex, cross-enterprise process-to-system programs, ensuring the quality and integrity of process design inputs to technology platforms and transformation initiatives.
- Own the function's process performance measurement framework, define enterprise KPIs, oversee reporting infrastructure, and present insights to senior leadership and governance bodies.
- Set and govern documentation standards, decision-record practices, and process governance infrastructure across Clinical Development Operations; maintain function-wide audit readiness.
- Potentially manage 0–5 direct reports; lead the team, set talent strategy, manage performance, and build the process engineering capability.
Benefits
- Paid time off, including vacation, holidays, and sick leave.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) for eligible employees.
- Eligible to participate in long-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Director
