Director, Clinical Process Engineering

Lead the Clinical Process Engineering team while contributing to the design, optimization, and sustainability of clinical business processes to enable operational excellence, compliance, and innovation across Clinical Development Operations. The Director, Clinical Process Engineering partners with business process owners, change, learning, and compliance teams to translate business needs into robust, scalable, and inspection-ready process designs that drive measurable business outcomes and continuous improvement.   Responsibilities:  • Lead Process Engineering Team and contribute to the design, mapping, and documentation of end-to-end clinical business processes, ensuring alignment with business needs, regulatory requirements, and process excellence standards.  • Collaborate with Business Process Owners (BPOs), Process Experts, and cross-functional stakeholders to define future-state processes, clarify decision rights, and ensure clear handoffs and ownership.  • Develop and maintain process maps, work instructions, SOP-aligned content, and supporting documentation using appropriate standards and methods (e.g., BPMN/process mapping, Lean/Six Sigma concepts).  • Conduct current-state assessment and process analysis (cycle time, handoffs, rework, risk) to identify improvement opportunities and inform fit-for-purpose future-state designs.  • Facilitate process design workshops and working sessions with SMEs, system owners, and compliance partners to gather requirements, validate process flows, and confirm controls and roles.  • Ensure process designs incorporate compliance, inspection readiness, and quality-by-design principles, including appropriate controls, traceability, and documentation rigor.  • Partner with technology and business system owners to translate process designs into system requirements and enablement (e.g., user stories, acceptance criteria, UAT support, and readiness inputs).  • Define and recommend process performance measures and instrumentation approaches; partner with BPOs to establish process signals and monitoring where applicable.  • Maintain controlled process documentation and decision records, ensuring updates are versioned, communicated, and aligned to governance and audit expectations.  • Bachelor’s degree in engineering, life sciences, business, or a related field required; advanced degree preferred.  • Lean Six Sigma or similar process methodology certification required.  • Minimum 10 years of demonstrated experience in process design, process engineering, and/or process improvement within a regulated environment (GxP, clinical development, quality systems, or similar).   • Working knowledge of clinical development operations and associated regulatory/inspection expectations (e.g., documentation rigor, traceability, and controls).  • Proficiency in process mapping and documentation techniques and tools; ability to develop clear, consumable process artifacts for diverse audiences.  • Experience facilitating workshops, eliciting requirements, and aligning stakeholders to achieve timely decisions and high-quality designs.  • Strong analytical skills (e.g., root cause analysis, risk assessment, process performance analysis) and structured problem solving.  • Experience partnering with technology/system teams on process-to-system translation (requirements, user stories, acceptance criteria, and UAT support).  • Strong written and verbal communication skills, including the ability to translate complex process topics into clear guidance and recommendations.  • Ability to work effectively in a matrixed, global environment and manage multiple priorities with strong attention to detail and accountability.  Key Stakeholders:  • Business Process Owners (BPOs) and Process Experts.  • Clinical