Kailera Therapeutics, Inc.

Associate Director, Clinical Oversight

Waltham, Massachusetts · Director · Full-time

Sponsorship not specified$159k-$195kDetected 15 days ago

GCPComplianceStakeholder ManagementPerformance ManagementClinical TrialsLeadershipCommunicationCollaborationProblem SolvingMicrosoft OfficeGxP

About the role

As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.
This role is accountable for designing and executing a comprehensive oversight framework that ensures high-quality trial execution, regulatory compliance, and inspection readiness globally.
This individual represents Kailera in oversight activities and plays a critical role in scaling processes, strengthening vendor governance, and advancing operational excellence.

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.
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
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
Lead and contribute to inspection readiness activities, audits, and regulatory interactions as needed

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
Strong experience with Vendor oversight, KPI tracking, and issue management
Proficiency with clinical systems (CTMS, eTMF, dashboards, Microsoft Office)
Ability to travel as needed
Proficient in oversight tools and systems (CTMS, eTMF, dashboards, Microsoft Office)
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

$159,000 - $195,000 USD
For Full Time Roles: This range represents the company's good-faith estimate of the salary at the time of posting.
Actual pay may vary based on experience, skills, qualifications, location, and internal equity.
Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants-because your well-being and future matter to us.
This range represents the company's good-faith estimate of the salary at the time of posting.

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 also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown.
Bachelor's degree in a scientific or healthcare-related field
Actual pay may vary based on experience, skills, qualifications, location, and internal equity.

Lead, mentor, and develop a high-performing global team of Clinical Oversight professionals
We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence.

Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.
Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.

tive hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-rel

This listing is sourced directly from Kailera Therapeutics, Inc.'s careers page and normalized into a canonical job model.