Kailera Therapeutics, Inc.

Healthcare

AssociateDirector,ClinicalOversight

$185–265k ~AI est. Waltham, Massachusetts, United States Remote Friendly
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Director candidates.

The Brief

“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.

Healthcare
Problems you'll solve

Problem-solving; Decision-making

Eligibility Requirements

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

Free ATS check

Applying for this Associate Director, Clinical Oversight role?

Most applicants get filtered before a human reads their resume. See if yours makes the cut.

How to Apply on Greenhouse

  • Create a Greenhouse profile before applying — it saves time across multiple applications.
  • Upload your resume as a PDF; the parser handles it better than Word.
  • Answer all knockout questions carefully — wrong answers auto-reject before a human sees you.
  • Enable email notifications to track application status in real time.

ANONYMOUS · UNFILTERED

What do employees actually say about Kailera Therapeutics, Inc.?

Real rants from real employees. Read before you apply.

Read Company Rants →