Director, Clinical Operations (Obesity) at MBX Biosciences in Burlington, MA

Job description

Working with Us MBX Biosciences is a clinical-stage biopharmaceutical company headquartered in Carmel, Indiana, with a secondary office in Burlington, MA. Our mission is to transform the lives of people impacted by endocrine and metabolic disorders through our novel precision peptides. Leveraging our proprietary Precision Endocrine Peptides (PEPs)™ platform, we are pioneering technology designed to overcome key limitations of existing therapies and enhance efficacy, tolerability, safety and convenience. Our team is advancing a pipeline of novel candidates with clinically validated targets, established endpoints for regulatory approval, and strong market potential. Our pipeline includes canvuparatide (MBX 2109) for the treatment of chronic hypoparathyroidism, currently preparing for Phase 3 development, and a growing obesity portfolio that includes MBX 4291 in Phase 1 development, MBX 5765, a next-generation amycretin prodrug designed for once-monthly-dosing, as well as MBX 6180, a GLP/GIP/GCGR triple agonist prodrug for once monthly dosing; all of which optimize our PEP platform. If you’re passionate about advancing innovative treatments for patients and shaping the future of precision peptide therapeutics, this is your chance to make a real impact alongside a fast-paced, growing, mission-driven team. To learn more, visit our website mbxbio.com and follow us on LinkedIn . What You’ll Do MBX Biosciences is seeking an experienced and highly motivated Director, Clinical Operations to lead the execution of clinical trials across our early-phase obesity portfolio. Reporting to the Head of Clinical Operations, this individual will provide 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 Pharmacology, Translational Medicine, and external vendors to advance innovative peptide-based therapies for patients with obesity and related metabolic disorders. This is a highly visible role requiring strong strategic thinking, hands-on study execution experience, vendor oversight expertise, and the ability to thrive in a fast-paced biotech environment. Key Responsibilities: Clinical Trial Leadership 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. Vendor and CRO Management 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. Cross-Functional Leadership 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. Clinical Operations Excellence 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. Strategic Contributions Provide opera