Director, Clinical Operations (Obesity)
About The Position
MBX Biosciences is seeking an experienced Director, Clinical Operations to lead execution of clinical trials across its early-phase obesity portfolio. Reporting to the Head of Clinical Operations, the Director provides operational leadership for Phase 1 and early Phase 2 studies, ensuring high-quality execution, compliance, and timely delivery of development milestones. The role is a visible cross-functional leadership position, partnering with Clinical Development, Medical, Biometrics, Regulatory, Clinical Pharmacology, Translational Medicine, and external vendors to advance peptide-based treatments for obesity and related metabolic disorders. It requires strategic thinking, hands-on study execution experience, vendor oversight expertise, and effectiveness in a fast-paced biotechnology environment. The position involves periodic travel as business needs require, including attendance at Together Weeks, Together Days, and functional meetings. Employees are expected to work hybrid schedules consistent with local office practices and the company's in-office policy.
Requirements
- Bachelor's degree in Life Sciences or a related discipline.
- 10+ years of progressive clinical operations experience in 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.
Responsibilities
- Lead operational planning, start-up, execution, and close-out of Phase 1 and early Phase 2 clinical trials in the obesity portfolio.
- Develop and maintain study timelines, enrollment projections, operational plans, and study budgets.
- Ensure studies comply with protocols, GCP, company SOPs, and applicable regulatory requirements.
- Identify operational risks and implement mitigation strategies.
- Lead selection, oversight, and performance management of CROs and other external vendors.
- Establish vendor expectations, governance structures, and performance metrics.
- Review vendor deliverables for quality, timeliness, and budget adherence.
- Manage study contracts, budgets, change orders, and forecasting.
- Serve as the operational lead on assigned program teams.
- Partner with Clinical Development and Medical teams on protocol development and study execution strategies.
- Collaborate with Biometrics, Regulatory Affairs, Clinical Pharmacology, Medical Writing, and Quality throughout the study lifecycle.
- Drive accountability across internal and external stakeholders.
- Develop and refine operational processes, tools, and standards to support portfolio growth.
- Support inspection readiness and quality management initiatives.
- Ensure comprehensive Trial Master Files and study documentation are maintained.
- Contribute to department development, resource planning, and continuous improvement.
- Provide operational input into clinical development plans and portfolio strategy discussions.
- Evaluate clinical trial technologies, vendors, and approaches to improve trial execution.
- Support due diligence activities and portfolio assessments as needed.
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What This Job Offers
Job Type
Full-time
Career Level
Director
