Director, Clinical Operations

Summary

Join Calyxo, a medical device company, as their Director of Clinical Operations. This leadership role demands strategic and financial oversight of clinical trials and post-market activities, ensuring compliance and alignment with company objectives. You will oversee the entire clinical program lifecycle, manage cross-functional teams and vendors, and foster continuous improvement. The position requires strong leadership, collaboration, and communication skills. Candidates can work in-office, remotely, or in a hybrid setting. A competitive compensation package is offered, including a base salary, stock options, and employee benefits.

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

Responsibilities

• 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
• 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
• Implement and manage clinical systems (e.g., EDC, ePRO, CTMS), ensuring data integrity and compliance
• Maintain operational responsibility for clinical data platforms
• 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
• 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
• 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
• 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
• Find joy, demonstrate integrity, be transparent, and win as a team!
• Perform other duties as needed

Preferred Qualifications

Experience in urology is preferable

Benefits

• 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