Director, Clinical Operational Excellence

Please note that this position is based in either San Diego CA or Princeton NJ. Acadias hybrid model requires this role to work in our office three days per week on average.

Position Summary

The Director of Clinical Operational Excellence will lead strategic initiatives that optimize and standardize clinical operations across global programs. This role is responsible for driving continuous improvement ensuring regulatory compliance and fostering a culture of quality and efficiency. Partnering cross-functionally and with Clinical Service Providers the Director will design and implement process improvements oversee training and SOP management and apply data-driven insights to enhance clinical trial execution. This is a key leadership position that will directly influence how Acadia delivers high-quality compliant and patient-focused clinical trials.

Primary Responsibilities

Operational Excellence & Process Improvement

• 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.

Process Management and Training Oversight

• 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.

Cross-Functional Collaboration

• Partner collaboratively with colleagues and leadership team to implement cross-functional initiatives that promote operational efficiency and drive clinical trial success.
• Collaborate with internal and external stakeholders including Clinical Operations teams and external vendors to streamline workflows and ensure alignment with best practices.
• Develop communication strategies to ensure transparency and alignment across functions. Facilitate workshops and forums to gather feedback and foster collaboration.
• Other duties as required.

Education/Experience/Skills

Bachelors degree in Life Sciences Business Engineering or a related field; Masters 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.

Key Skills:

• 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 Clinical Trial Management Systems (CTMS) eTMF Veeva Vault platforms (Quality Docs Clinical Safety RIM Change Control CAPA Audits Complaints Quality Risk Management (QRM) Supplier Management) and related platforms.
• Must be able to travel on occasion.

Physical Requirements

This role involves regular standing walking sitting and the use of hands for handling or operating equipment. The employee may also need to reach climb balance stoop kneel crouch and maintain visual verbal and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

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Required Experience:

Director