The posting
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 and participate in audits and regulatory inspections as needed.
- Review study documents, trial master file metrics, and quality indicators to ensure regulatory compliance.
Budget and Financial Management
- Assist in development and management of clinical trial budgets and forecasts.
- Review vendor invoices and provide budget oversight throughout the study lifecycle.
- Monitor study expenditures and communicate potential budget risks.
What You Bring
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related scientific discipline.
- Minimum of 8 years of clinical research experience, including at least 3 years in a Clinical Trial Manager or equivalent leadership role.
- Experience managing Phase II and/or Phase III clinical trials in the biotechnology or pharmaceutical industry.
- Experience leading CROs and external clinical vendors.
- Strong understanding of ICH-GCP, FDA regulations, and global clinical trial conduct.
Preferred Qualifications
- Advanced degree (MS, MPH, PharmD, or equivalent) preferred.
- Experience in endocrinology, rare disease, metabolic disease, or related therapeutic areas.
- Experience supporting NDA/BLA-enabling studies preferred.
- Experience in a growth-stage biotechnology environment.
Travel & In Office Presence
You will be expected to travel periodically based on the needs of the business, including attendance at Together Weeks, Together Days, and functional meetings as requested by the team. Employees are expected to work on hybrid schedules, consistent with local office practices and the terms of the companies in office policy as in effect from time to time.
EEO Statement:
MBX Biosciences is an Equal Opportunity Employer and is committed to treating all applicants fairly without discrimination. We welcome applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law.
