Associate Director, Clinical Oversight
$159,000–$195,000 year
On-site · Waltham, Massachusetts, United States
Job Summary
Associate Director, Clinical Oversight (ADCO) provides strategic leadership and operational direction for Clinical Monitoring Oversight across Kailera’s clinical development programs, designing and executing an oversight framework to ensure high-quality trial execution, regulatory compliance, and inspection readiness globally. The role partners with Clinical Operations, Quality, and external vendors to drive oversight strategy, performance management, and continuous improvement; leads and mentors a global Clinical Oversight team; defines SOPs, monitoring plans and governance models; oversees service providers, KPIs, risk-based monitoring, data integrity, and site management; contributes to inspection readiness, audits, and regulatory interactions; requires hub-based presence in Waltham, MA (onsite 3-4 days/week).
Required Qualifications
- Bachelor’s degree in a scientific or healthcare-related field
- 10+ years of clinical trial experience with significant leadership experience in clinical oversight, monitoring, or operations
- Experience 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
- Ability to travel as needed
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