Senior Clinical Trial Manager 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 Senior Clinical Trial Manager (Sr. CTM) to lead the operational execution of clinical studies across one or more development programs. The Sr. CTM will serve as the primary operational lead for assigned trials and will be responsible for managing study conduct from startup through closeout while ensuring compliance with regulatory requirements, Good Clinical Practice (GCP), company SOPs, and timelines. The ideal candidate is a proactive problem solver with strong cross-functional leadership skills, experience managing global and/or multicenter clinical trials, and a passion for driving operational excellence in a fast-paced biotech environment. Clinical Trial Leadership Lead day-to-day operational management of Phase II and Phase III clinical trials from study startup through database lock and study closeout. Serve as the primary clinical operations lead for assigned studies and provide regular updates to leadership and study teams. Develop and maintain study timelines, enrollment projections, risk management plans, and operational metrics. Identify, escalate, and resolve study-related issues while proactively mitigating risks to trial execution. Vendor and CRO Management Oversee CROs and external vendors to ensure adherence to scope, timelines, quality expectations, and budget. Lead vendor selection, qualification, oversight, and performance management activities. Review vendor deliverables and monitor key performance indicators to ensure study milestones are met. Partner with vendors to drive operational efficiencies and continuous improvement. Cross-Functional Collaboration Collaborate closely with Clinical Development, Data Management, Biostatistics, Medical Monitoring, Regulatory Affairs, Pharmacovigilance, Clinical Supply, Quality Assurance, and other functional areas. Lead cross-functional study team meetings and ensure alignment across stakeholders. Contribute to study planning, protocol development, investigator meetings, and operational strategy discussions. Site Management and Oversight Support site feasibility, site selection, activation, enrollment, retention, and closeout activities. Review monitoring reports and study metrics to identify trends and areas requiring intervention. Ensure appropriate oversight of site performance, data quality, and protocol compliance. Regulatory and Quality Compliance Ensure studies are conducted in compliance with ICH-GCP guidelines, applicable regulations, company SOPs, and protocol requirements. Support inspection readiness activities