Executive Director, Head of Clinical Operations Excellence

Role Summary

As a crucial member of the Global Clinical Operations (GCO) leadership, this position contributes extensively to shaping Clinical Development and GCO strategies. The role entails providing expert guidance and leadership concerning processes, eTMF management, quality assurance, and compliance across all clinical operations managed by the Global Clinical Operations Organization and its partners.

Key Responsibilities

• Lead the creation, execution, and continuous refinement of a proactive GCP compliance system and infrastructure within GCO, focusing on clinical trial oversight, monitoring, eTMF quality control, SOPs, training programs, and change management.
• Develop and manage a highly skilled team dedicated to advancing infrastructure and system enhancements.
• Ensure regulatory adherence to standards set by ICH, FDA, EMA, PMDA, and others, employing cutting-edge methodologies and clinical performance indicators (KPIs/KQIs) for process enhancement.
• Collaborate with Quality Assurance, Corporate Compliance, GCO and Development peers to investigate root causes of critical audit findings, formulate corrective action plans, and oversee their implementation and effectiveness.
• Foster development among direct and indirect reports such as Clinical Study Managers and CRAs, enhancing value-addition across business units and regions.
• Lead initiatives to embed operational excellence within Clinical Development and GCO for expedited and high-quality clinical trials globally.

Procedures and Process Management

• Participate in GCO leadership and strategy planning, lending expertise in quality, compliance, and operational excellence across various clinical trial functions and partners.
• Oversee end-to-end compliance with SOPs, ensuring departmental alignment with procedural and policy standards across trials.
• Identify and address process inefficiencies through ongoing performance monitoring and quality indicators, collaborating with clinical development teams to implement innovative and standardized operational improvements.

Training and Performance Metrics

• Design and execute training programs for Global Clinical Operations and related functions to guarantee knowledge retention and application.
• Ensure training compliance meets corporate and organizational targets.
• Develop, monitor, and communicate KPI/KQIs related to clinical quality and compliance to senior leadership and executive committees.

Compliance & eTMF Management

• Maintain and enhance the GCO Compliance Management Plan, including eTMF governance, cooperation with Clinical Quality Assurance, and preparation for inspections.
• Investigate and address emerging compliance risks, manage root cause analyses, and oversee corrective/preventive actions linked to audits and inspections.
• Utilize AI-driven improvements to optimize the eTMF platform and lead teams through associated change management and inspection readiness efforts.

Additional Responsibilities

• Contribute to clinical trial sourcing strategies and lead vendor due diligence activities.
• Escalate critical issues to senior leadership when necessary.
• Lead multi-disciplinary and multinational teams to ensure quality clinical trial execution.

Supervisory Duties

• Manage both direct and indirect reports including internal staff and external resources to uphold GCP compliance globally.
• Provide mentorship and coaching to Clinical Operations teams as required.

Qualifications

• Bachelor of Science degree required with advanced degrees preferred in scientific or healthcare related fields.
• A minimum of 15 years of experience in biotech, pharmaceutical, or CRO sectors, involving Clinical Operations, Compliance, Monitoring, Trial Management, or Quality Assurance.
• Proficient with Microsoft Office tools including Word, Excel, Project, PowerPoint, and Outlook.
• Fluent English communication skills; Mandarin knowledge is an advantage.
• Extensive expertise in building GCP quality systems, SOP development, and CAPA programs.
• Strong leadership capabilities and a mindset centered on risk-based management.
• Skilled in Project Management, Root Cause Analysis, and CAPA management.
• Preferred knowledge of Six Sigma, Lean, and Agile methodologies.

Additional Information

• Up to 25% travel expected.
• Strong emphasis on values such as Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit.
• Global competencies include teamwork, giving and receiving feedback, self-awareness, inclusivity, initiative, entrepreneurial mind, continuous learning, adaptability, results orientation, analytical thinking, financial acumen, and clear communication.

Compensation and Benefits

The annual salary range for this position is from $271,800 to $351,800. Compensation is based on candidate-specific factors such as skill set, experience, certifications, education, training, and location. The package may include bonuses or incentive compensation plans, equity awards, and participation in employee stock purchase programs. Comprehensive benefits cover medical, dental, vision, 401(k), FSA/HSA, life insurance, paid time off, and wellness programs.