Kailera Therapeutics, Inc.
Healthcare
AssociateDirector,ClinicalOversight
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“Associate Director, Clinical Oversight at Kailera Therapeutics, Inc.. Skills: Clinical Oversight, Clinical Monitoring, Risk-based monitoring, Vendor Management. Define Clinical Monitoring Oversight strategy. Develop oversight SOPs and templates”
What You'll Achieve.
Ensure high-quality trial execution; Ensure regulatory compliance; Ensure inspection readiness globally; Achieve study milestones; Strengthen vendor governance; Advance operational excellence
Industry & Context.
Problem-solving; Decision-making
Travel as needed
What They're Looking For.
Must Have
10+ years clinical trial experience, Significant leadership experience, Phase I–III clinical trials expertise, Risk-based monitoring expertise, CRA Management expertise, Bachelor’s degree in scientific or healthcare-related field
Nice to Have
Vendor oversight experience, KPI tracking experience, Issue management experience
What You'll Do.
Define Clinical Monitoring Oversight strategy
Develop oversight SOPs and templates
Develop Clinical Oversight Monitoring plans
Align with corporate goals
Align with regulatory expectations
Align with risk-based monitoring
Improve oversight SOPs
Improve oversight standards
Improve oversight tools
Improve oversight governance models
Provide executive oversight of SPs
Ensure SP performance
Evaluate SP activities
Recommend SP activities
Ensure appropriate scope of work
Ensure appropriate oversight
Ensure appropriate CRA training
Achieve study milestones
Oversee clinical oversight visits
Ensure consistent risk-based approaches
Oversee SP execution of activities
Evaluate SP operational data
Identify risks proactively
Drive data-informed decisions
Collaborate with Clinical Oversight team
Collaborate with Clinical Quality Management
Collaborate with Clinical Study Team
Implement corrective actions
Monitor progress through resolution
Facilitate resolution of challenges
Act on behalf of Business Operations
Assist creation of department initiatives
Assist delivery of department initiatives
Assist creation of improvement plans
Assist delivery of improvement plans
Assist creation of training
Assist delivery of training
Establish performance expectations
Foster accountability culture
Foster collaboration culture
Foster continuous improvement culture
Ensure oversight of data integrity
Ensure oversight of subject safety
Ensure oversight of protocol compliance
Lead inspection readiness activities
Contribute to inspection readiness activities
Lead regulatory interactions
Contribute to regulatory interactions
Conduct periodic quality visits
Approve vendor invoices
How You'll Work.
Team & Collaboration
Cross-functional project teams; Clinical Operations; Quality; External vendors; Clinical Oversight team; Clinical Quality Management; Clinical Study Team; Business Operations
Communication Scope
Influencing; Stakeholder management
Full Job Description
At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions. We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team. 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 expectati
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