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.