Director, Clinical Operations – Early-Phase Biotech

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

Job summary

MBX Biosciences, Inc. in Burlington, MA is seeking a Director of Clinical Operations to lead execution of Phase 1 and early Phase 2 trials within the obesity portfolio.

The role reports to the Head of Clinical Operations and requires delivering high-quality, compliant studies on schedule. You will partner with Clinical Development, Medical, Biometrics, Regulatory, Clinical Pharmacology, and external vendors to advance peptide-based therapies for obesity and metabolic disorders.

Qualifications

• 10+ years in clinical operations within biotech/pharma.
• Experience leading Phase 1 and/or early Phase 2 trials.
• Proven CRO/vendor management and global studies.
• Strong understanding of ICH-GCP and FDA regulations.

Responsibilities

• Lead the operational planning, start-up, execution, and close-out of Phase 1 and early Phase 2 trials.
• Manage CROs and external vendors, including budgets, timelines, and quality.
• Serve as operational lead on program teams and partner with Clinical Development, Medical, Biometrics, Regulatory, and QA.
• Develop and refine processes, tools, and standards to support portfolio growth and inspection readiness.
• Provide strategic input into development plans and evaluation of new trial technologies.

Skills

Project management

Stakeholder mgmt

ICH-GCP

Biotech industry experience

Cross-functional leadership

Education

Bachelor's degree in Life Sciences

Tools

CTMS

Job description

MBX Biosciences, Inc. in Burlington, MA is seeking a Director of Clinical Operations to lead execution of Phase 1 and early Phase 2 trials within the obesity portfolio.

The role reports to the Head of Clinical Operations and requires delivering high-quality, compliant studies on schedule. You will partner with Clinical Development, Medical, Biometrics, Regulatory, Clinical Pharmacology, and external vendors to advance peptide-based therapies for obesity and metabolic disorders.