Associate Director, Clinical Oversight

What You’ll Do:

The Associate Director, Clinical Oversight (ADCO) provides strategic leadership and operational direction for Clinical Monitoring Oversight across Kailera’s clinical development programs. This role is accountable for designing and executing a comprehensive oversight framework that ensures high-quality trial execution, regulatory compliance, and inspection readiness globally.

The ADCO serves as a senior leader and key partner to Clinical Operations, Quality, and external vendors, driving oversight strategy, performance management, and continuous improvement across studies and programs. This individual represents Kailera in oversight activities and plays a critical role in scaling processes, strengthening vendor governance, and advancing operational excellence.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Responsibilities:

• Define and lead the Clinical Monitoring Oversight strategy across studies, including development and oversight of Clinical Monitoring Oversight SOPs and templates, Clinical Oversight Monitoring plans, ensuring alignment with corporate goals, regulatory expectations, and evolving risk-based monitoring approaches
• Establish and continuously improve oversight SOPs, standards, tools, and governance models
• Provide executive oversight of clinical service providers (SPs), ensuring performance, quality, and compliance expectations are met
• Evaluates and provides recommendations to the study team on Oversight Service Provider activities to ensure the appropriate scope of work, oversight, and training of clinical oversight CRAs to achieve study milestones within agreed upon timelines, budget, and quality
• Oversee the planning and execution of clinical oversight visits and ensure consistent application of risk-based approaches
• Provides oversight on service provider execution of clinical trial activities in accordance with Kailera SOPs, ICH Guidelines, and Good Clinical Practice (GCP)
• Develops key performance indicators (KPIs) and evaluates service provider operational data against KPIs to proactively identify risks and drive data-informed decisions
• Collaborates with the Clinical Oversight team, Clinical Quality Management, and Clinical Study Team to implement corrective actions and monitor progress through resolution
• Facilitate resolution of region specific and site management related challenges
• Acts on behalf of Business Operations on cross-functional project teams; interacts with internal and external groups
• Assist with creation and delivery of department initiatives, improvement plans and/or training
• Lead, mentor, and develop a high-performing global team of Clinical Oversight professionals
• Establish clear performance expectations and foster a culture of accountability, collaboration, and continuous improvement in accordance with applicable SOPs, regulations, GCP, Key Performance Indicators (KPIs), and study-specific requirements
• Ensure robust oversight of data integrity, subject safety, and protocol compliance at investigator sites
• Lead and contribute to inspection readiness activities, audits, and regulatory interactions as needed
• Conduct periodic quality visits for Oversight CRAs, as needed
• Ensure the oversight CRAs are reviewing and ensuring data integrity, accuracy, and completeness at the clinical study sites
• Review contracts and approve vendor invoices

Qualifications:

• 10+ years of clinical trial experience with significant leadership experience in clinical oversight, monitoring, or operations
• Demonstrated expertise with Phase I–III clinical trials, risk-based monitoring, and CRA Management
• Proficient in oversight tools and systems (CTMS, eTMF, dashboards, Microsoft Office)
• Strong experience with Vendor oversight, KPI tracking, and issue management
• Proven ability to lead and develop high-performing teams in a complex, fast-paced environment
• Excellent organizational, analytical, and interpersonal skills; able to work independently and in teams
• Strong strategic thinking, problem-solving, and decision-making capabilities
• Excellent communication, influencing, and stakeholder management skills
• Proficiency with clinical systems (CTMS, eTMF, dashboards, Microsoft Office)
• Ability to travel as needed

Education:

• Bachelor’s degree in a scientific or healthcare-related field