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MBX Biosciences is a clinical-stage biopharmaceutical company headquartered in Carmel, Indiana, with a secondary office in Burlington, MA. The company is pioneering precision peptide therapeutics to treat endocrine and metabolic disorders, including obesity. The company's pipeline includes candidates in Phase 1 and Phase 3 development stages, leveraging a proprietary Precision Endocrine Peptides (PEPs) platform.
The Director, Clinical Operations will lead the execution of clinical trials across the early-phase obesity portfolio, reporting to the Head of Clinical Operations. This is a highly visible role requiring strategic thinking, hands-on study execution experience, and vendor oversight expertise in a fast-paced biotech environment.
Key responsibilities include:
**Clinical Trial Leadership:** Lead operational planning, start-up, execution, and close-out of Phase 1 and early Phase 2 clinical trials. Develop and maintain study timelines, enrollment projections, operational plans, and budgets. Ensure studies are executed in accordance with protocol, GCP, company SOPs, and applicable regulatory requirements. Identify operational risks and implement proactive mitigation strategies.
**Vendor and CRO Management:** Lead selection, oversight, and performance management of CROs and external vendors. Establish clear expectations, governance structures, and performance metrics. Review vendor deliverables for quality, timelines, and budget adherence. Manage study-related contracts, budgets, change orders, and forecasting.
**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.
Travel is expected periodically based on business needs, including attendance at Together Weeks, Together Days, and functional meetings. Employees work on hybrid schedules consistent with local office practices.
**Requirements:**
- 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
