Director – Clinical Operations

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:

• Vice President, Medical and Clinical Affairs

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, analysis, and outcomes reporting
• Intimate working knowledge of best practices and compliance policies that govern the industry. Comprehensive knowledge of ISO, ICH/GCP, FDA, and other applicable regulations governing the conduct of clinical trials.
• Demonstrated ability to work collaboratively and effectively with key opinion leaders, investigators, and cross-functional teams.
• Excellent communication, interpersonal, problem-solving, organization, and decision-making skills. Ability to prioritize projects, take initiative and remain flexible.
• Ability to travel up to 50% of the time
• Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint etc.)
• 3-5 years experience with clinical trial management software and electronic data capture methods
• Compliance with relevant county, state, and Federal rules regarding vaccinations.

Preferred Qualifications:

• Experience in urology is preferable.

What We Offer:

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced and fun team.  You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture.  You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself. 

We also offer an attractive compensation package, which includes:

• A competitive base salary of $200,000 - $230,000 and variable incentive plan
• Stock options – ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid vacation