Director, Clinical Operations (Obesity)

MBX Biosciences, Inc.; Burlington (MA); Hybride; USD 180 000 - 240 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Project management

Stakeholder mgmt

ICH-GCP

Biotech industry experience

Cross-functional leadership

Formation

Bachelor's degree in Life Sciences

Outils

CTMS

Description du poste

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.

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.

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 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.

What You Bring

• 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.

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.

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.