Director, Clinical Operations - Remote

Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common, painful condition that consumes vast amounts of healthcare resources each year. Our team is led by executives and investors with a proven track record of commercializing paradigm-shifting devices to meet unmet needs within urology.

Are you ready to change the future of kidney stone treatment? We are seeking high achievers who want to be part of a dynamic team working in a fun, diverse atmosphere.

Summary:

The Director of Clinical Operations provides strategic, operational, and financial leadership for clinical trials and post-market clinical activities. This role oversees the design and execution of clinical programs from concept through completion, ensuring compliance with regulatory standards and alignment with company objectives. The Director manages cross-functional teams, CROs, and vendors to ensure the successful delivery of clinical evidence in support of commercialization and regulatory strategy. This position also fosters continuous improvement across clinical operations and serves as a key partner within the Medical & Clinical Affairs team. Candidates may be in-office, remote, or hybrid.

In This Role, You Will:

Strategic and Financial Oversight

• Develop and implement clinical operations strategies aligned with corporate goals.
• Lead clinical program planning, budgeting, and resource allocation.
• Monitor clinical program financial performance, ensuring efficiency and cost control.

Clinical Trial Management

• Oversee the full lifecycle of clinical trials and registries, including protocol development, site selection, execution, data collection, and study close-out.
• Identify, select, and manage CROs and third-party vendors to ensure quality and timeliness.
• Supervise clinical monitoring, site management, and internal/external clinical operations staff.
• Review clinical data, resolve queries, and ensure timely data lock.
• Cultivate strong relationships with investigators, KOLs, surgeons, and research staff.
• Plan and conduct investigator and research coordinator meetings.

Technology and Systems Management

• Implement and manage clinical systems (e.g. EDC, ePRO, CTMS), ensuring data integrity and compliance.
• Maintain operational responsibility for clinical data platforms.

Risk and Quality Management

• Proactively identify, assess, and mitigate risks across clinical programs.
• Ensure compliance with FDA, ISO, ICH/GCP, and internal SOPs.
• Develop and maintain SOPs, workflows, and best practices for clinical operations.
• Ensure audit readiness and drive continuous improvement initiatives.

Performance Monitoring & Metrics

• Define and track key performance indicators (KPIs) to assess study performance and operational efficiency.
• Use data-driven insights to inform decision-making and optimize performance.

Team Leadership

• Recruit, mentor, and develop a strong clinical operations team, including clinical managers, CRAs, and other clinical operations staff.
• Foster a high-performance culture focused on accountability, collaboration, and professional development.

Cross-Functional Collaboration

• Partner with Medical Affairs, Regulatory, Quality, and Commercial teams to support clinical evidence generation, product development, scientific communications, and market access.
• Contribute to the development of clinical publications, presentations, and training materials.
• Collaborate cross-functionally on speaker engagements, presentation preparation, and physician training events to disseminate clinical trial strategy and results to support product adoption and awareness.

Core Value Demonstration

• Find joy, demonstrate integrity, be transparent, and win as a team!
• Perform other duties as needed.

 

 

Who You Will Report To:

• See Organizational Chart

Requirements:

• Bachelor’s degree in Life Sciences or a related field; advanced degree preferred.
• Minimum of 5 years of clinical experience and leadership roles in the medical device industry.
• Deep understanding of clinical research methodologies and trial execution in the medical device space.
• Experience with questionnaire development, data collection, aggregation, analy