Director, Clinical Operational Excellence

Role Summary

Director of Clinical Operational Excellence will lead strategic initiatives that optimize and standardize clinical operations across global programs, driving continuous improvement, ensuring regulatory compliance, and fostering a culture of quality and efficiency. This leadership role designs and implements process improvements, oversees training and SOP management, and applies data-driven insights to enhance clinical trial execution.

Responsibilities

• Develop, lead and implement process optimization strategies for clinical operations to enhance efficiency, reduce costs, and ensure regulatory compliance through strategic leadership, process management and change enablement.
• Lead Clinical Operations strategic planning sessions to align process improvement goals with long-term business objectives.
• Establish mechanisms to identify, prioritize and resolve process issues/gaps within Clinical Operations; work to prioritize and implement process improvements, where required, through collaborative problem solving and effective communication.
• Identify opportunities for improvement within existing operational processes and lead the implementation of continuous improvement programs, applying methodologies such as Lean Six Sigma, to drive measurable outcomes.
• Track and report performance metrics to demonstrate impact of improvements.
• Lead the production and reporting of operational excellence metrics to the Clinical Operations Leadership Team and key internal stakeholders, driving decisions based on data and analysis.
• Ensure GCP compliance and data integrity through data-driven insights.
• Oversee creation, maintenance and obsolescence of Clinical SOP/WI/Forms/Templates; direct work related to new process creation, training and rollout.
• Manage QMS CAPAs, Deviations, and Document Change Controls (DCCs); support and manage audit findings and resolutions.
• Monitor Clinical Operations training compliance; manage processes for ensuring that clinical operations and related CSPs using ACADIA processes are current with training and training documentation; may conduct training for small groups and participate in training sessions for CSPs
• Manage the Clinical Operations Training Curricula; work with Quality to align curricula assignments with applicable SOPs and ensure standardization across functions.
• Serve as SME on regulatory requirements and industry best practices related to Clinical Operations processes and training compliance.
• Collaborate with cross-functional teams to address training gaps and develop training materials as needed. Lead and conduct training sessions.
• Drive change management initiatives to support adoption of new processes and systems. Promote a culture of continuous improvement and quality mindset across Clinical Operations.

Qualifications

• Bachelor‚Äôs degree in Life Sciences, Business, Engineering, or a related field; Master‚Äôs degree preferred. Targeting 10 years of relevant progressive experience in clinical operations, with a focus on operational excellence and process improvement. An equivalent combination of relevant education and experience may be considered.
• Demonstrated experience in leading process optimization initiatives and driving operational efficiencies in a global clinical trial setting.
• Strong clinical operations and project management skills with expertise in process improvement methodologies (e.g., Lean, Six Sigma).
• Previous management experience with demonstrated leadership capabilities.
• Excellent communication and interpersonal skills, with the ability to work effectively across teams and with external vendors.
• Proficiency in clinical operations systems and tools such as CTMS, eTMF, Veeva Vault platforms (Quality Docs, Clinical, Safety, RIM, Change Control, CAPA, Audits, Complaints, QRM, Supplier Management) and related platforms.
• Must be able to travel on occasion.

Skills

• Process optimization
• Lean Six Sigma
• Clinical operations leadership
• Project management
• Cross-functional collaboration
• Data-driven decision making
• Regulatory compliance (GCP)
• Training and SOP management

Education

• Bachelor‚Äôs degree required; Master‚Äôs degree preferred.

Additional Requirements

• Regular standing, walking, sitting, and use of hands; ability to travel overnight as needed.