Director, Clinical Operations - Obesity Trials Lead

MBX Biosciences, Inc.; Burlington (MA); Hybrid; USD 180,000 - 240,000; Full time

Job summary

MBX Biosciences is seeking an experienced Director, Clinical Operations to lead the execution of early‑phase obesity trials, reporting to the Head of Clinical Operations. This role provides operational leadership for Phase 1 and early Phase 2 studies, ensuring high‑quality execution, compliance, and timely delivery of development milestones.

The Director will serve as a key cross‑functional leader, partnering closely with Clinical Development, Medical, Biometrics, Regulatory, Clinical

Qualifications

• Bachelor’s degree in Life Sciences or related discipline.
• 10+ years of progressive clinical operations experience within biotechnology, pharmaceutical, or CRO environments.
• Experience leading Phase 1 and/or early Phase 2 clinical trials.
• Demonstrated success managing CROs and global or multicenter studies.
• Strong understanding of ICH‑GCP, FDA regulations, and clinical trial execution.
• Excellent project management, communication, and stakeholder management skills.
• Ability to work independently in a dynamic, growth‑stage biotechnology environment.

Responsibilities

• Lead the operational planning, start‑up, execution, and close‑out of Phase 1 and early Phase 2 clinical trials within the obesity portfolio.
• Develop and maintain study timelines, enrollment projections, operational plans, and study budgets.
• Ensure studies are executed in accordance with protocol, GCP, company SOPs, and applicable regulatory requirements.
• Identify operational risks and implement proactive mitigation strategies to support study delivery.
• Lead selection, oversight, and performance management of CROs and other external vendors.
• Establish clear expectations, governance structures, and performance metrics.
• Review vendor deliverables and ensure quality, timelines, and budget adherence.
• Manage study‑related contracts, budgets, change orders, and forecasting activities.
• Serve as the operational lead on assigned program teams.
• Partner with Clinical Development and Medical teams to support protocol development and study execution strategies.
• Collaborate with Biometrics, Regulatory Affairs, Clinical Pharmacology, Medical Writing, and quality functions throughout the study lifecycle.
• Drive accountability across internal and external stakeholders.
• Develop and refine operational processes, tools, and standards to support portfolio growth.
• Support inspection readiness activities and quality management initiatives.
• Ensure maintenance of comprehensive Trial Master Files and study documentation.
• Contribute to department development, resource planning, and continuous improvement efforts.
• Provide operational input into clinical development plans and portfolio strategy discussions.
• Evaluate emerging clinical trial technologies, vendors, and innovative approaches to improve trial execution.
• Support due diligence activities and portfolio assessments as needed.

Skills

Clinical operations

CRO management

GCP compliance

Project management

Education

Bachelor’s degree in Life Sciences or related discipline

Job description

MBX Biosciences is seeking an experienced Director, Clinical Operations to lead the execution of early‑phase obesity trials, reporting to the Head of Clinical Operations. This role provides operational leadership for Phase 1 and early Phase 2 studies, ensuring high‑quality execution, compliance, and timely delivery of development milestones.

The Director will serve as a key cross‑functional leader, partnering closely with Clinical Development, Medical, Biometrics, Regulatory, Clinical