Biology & Biotech (2)

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 Senior Clinical Oversight Manager (COM) is responsible for executing the Clinical Monitoring Oversight visit process and Clinical Oversight Metrics. The Senior COM represents Kailera during Clinical Oversight visits and oversees study execution to ensure compliance with ICH GCP, and applicable regulations. The Senior COM is involved in planning, execution, and delivery of oversight processes including Standard Operating Procedures (SOP) and work instructions.

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

Responsibilities:

Develops the Clinical Monitoring Oversight strategy across studies, including development and oversight of Clinical Monitoring Oversight SOPs and templates, Clinical Oversight Monitoring plans, managing Monitoring Oversight Service Provider (SP) activities, providing study/program/SP level reporting, and leading monthly TMF health checks
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
Assigns oversight visits at trial sites based on strategic criteria to evaluate compliance of trials with local regulatory requirements; overall data quality and integrity; and human subject protection
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 identify potential performance gaps
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
Selects and oversees Oversight CRAs globally, driving the team to ensure study deliverables are met with efficiency and quality in accordance with applicable SOPs, regulations, GCP, Key Performance Indicators (KPIs), and study-specific requirements
Responsible for ensuring Oversight CRAs maintain their sites/studies as inspection ready, including the TMF, for health authority inspections
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
Support and liaise with clinical site personnel, as needed
Review contracts and approve vendor invoices

Qualifications:

Minimum of 8+ years of clinical trial experience with strong knowledge of the clinical development process
Experience with Phase I–III clinical trials, risk-based monitoring, and CRA Management
Proficient in oversight tools and systems (CTMS, eTMF, dashboards, Microsoft Office)
Experience with Vendor oversight, KPI tracking, and issue management
Strong leadership, collaboration, and communication skills with the ability to manage and motivate team members (e.g., internal staff and external investigators/consultants)
Excellent organizational, analytical, and interpersonal skills; able to work independently and in teams
In-depth knowledge of ICH-GCP, FDA, EMA, and global regulatory requirements
Ability to manage complexity in a fast-paced environment
Must have strong clinical study management, communication (oral and written), and analytical skills
Must be able to travel

Education:

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

Salary Range

$143,000—$175,000 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. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. 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.

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION:

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.

E-Verify:

Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.

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Senior Clinical Oversight Manager

Kailera Therapeutics

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