Director, Clinical Operations

Overview

At Vericel Corporation, we are pioneers in advanced cell therapies for sports medicine and severe burn care, transforming patient lives through cutting-edge regenerative medicine. Our commitment to innovation, patient-centered focus, and scientific excellence drives us to develop treatments including MACI (knee cartilage repair), Epicel and Nexobrid (burn care).

The Director, Clinical Operations is a senior leader within the Clinical Affairs function, responsible for both strategic oversight and hands-on execution of clinical studies. This role provides leadership to the Clinical Operations team and is accountable for end-to-end operational planning and execution at the study level, from start-up through conduct, reporting, and close-out. Key responsibilities include oversight of study timelines, data quality, and budgets, with a strong focus on managing and collaborating with internal teams, CROs, and other third-party vendors.

The Director, Clinical Operations ensures that clinical trial milestones and deliverables - including those for Phase III studies - are achieved in alignment with agreed quality standards and timelines supporting regulatory submissions. This role serves as a primary point of contact for internal and external stakeholders, communicating study status, proactively escalating risks or issues, and resolving operational challenges. Provides operational oversight for assigned clinical trials and registries and acts as an escalation point for the Clinical Operations team.

This role is responsible for direct management of multiple team members.

This position is in-office from Monday – Thursday in our new Burlington, MA location, with flexibility to work remotely on Fridays.

• Lead, manage, and develop Clinical Operations staff and mentor more junior personnel within the Clinical Affairs department.
• Own study-level timelines, budgets, quality, and operational deliverables to ensure successful execution of clinical studies and registries.
• Provide strategic input and lead investigator recruitment/selection across projects or programs.
• Develop and improve infrastructure to support all clinical trials and registries.
• Drive continuous improvement of departmental processes and ensuring compliance with applicable national and international regulations and guidelines (e.g., ICH E6 R3).
• Lead the development and updates of essential records including clinical study plans and other study documentation.
• Establish and ensure consistent team adherence to internal procedures and standards for study planning, conduct, close-out, and reporting.
• Proactively assess potential risks to studies and propose mitigation plans and serve as a point of escalation for the study team.
• Effectively work cross-functionally to ensure the broader Vericel team is engaged in activities in support of trial execution and program objectives.
• Oversee internal and CRO/study vendor trial activities and coordinates with internal and external functional groups to ensure sites are activated and supported throughout the trial lifecycle.
• Maintain accountability for study budget forecasting, tracking, and accrual projections, including approval of vendor and site invoices, in collaboration with Finance.
• Develop working relationships with study investigators, Data Safety Monitoring Board members and Steering Committee members, as required.
• Provide oversight and review of Clinical Operations’ materials supporting submissions to the FDA and other global regulatory agencies, as required.
• Create, review and approve standard operating procedures that impact Clinical Affairs.
• Execute clinical programs in compliance with quality standards (ICH/GCP, Global Regulations, and Vericel policies and procedures).
• Verify the Trial Master File (TMF) is set up and maintained appropriately for all studies, including performing periodic reviews
• Accountable for ensuring team member compliance with training requirements in the Learning Management System.
• Participate in internal audit(s) and external inspections and be able to represent Clinical Affairs as a Subject Matter Expert.
• Participate in co-monitoring, SQV and SIV…