Director, Clinical Operations - Burlington, MA, US

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 ...

Job description

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 groundbreaking treatments including MACI (knee cartilage repair), Epicel and Nexobrid (burn care). 

Position Summary: 

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.

Schedule: 

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

Position Scope: 

• 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 visits for ongoing clinical trials, as needed.
• Other duties as assigned.

Qualifications: 

• 12+ years of pharmaceutical /biotech industry experience in areas of clinical trial design, data management, study management, study monitoring, analysis and reporting.
• Minimum of 5 years of experience in clinical operations management (studies and staff) 
• Strong leadership, sound decision-making, and proven clinical project management expertise, along with excellent written and verbal communication skills and close attention to detail.
• Strong knowledge of FDA regulations on good clinical practices (GCP).
• Practical knowledge of International Conference on Harmonisation (ICH)-GCP guidelines for clinical trials.
• Cell therapy experience preferred.
• Proven experience in managing and monitoring clinical trials from initiation through close-out.
• Demonstrated ability to lead and manage cross-functional teams and mentor junior staff.
• Strong analytical and problem-solving abilities.
• Ability to effectively manage multiple priorities and meet deadlines.
• Proficiency with clinical trial management systems (CTMS) and other clinical software [e.g., Electronic Data Capture (EDC) platforms].
• Detail-oriented, with the ability to maintain high standards of accuracy and quality.

Why Vericel? 

• Cutting-Edge Science: Work with a leading regenerative medicine product that is transforming patient care.
• Career Growth: Be a part of a growing organization with opportunities to expand your impact.
• Collaborative Culture: Work alongside a team of dedicated professionals who are passionate about improving lives.

The salary range Vericel reasonably and in good faith expects to pay for this position at the time of this posting is $200,000 to $230,000 annually.

The actual salary offered will be determined based on factors such as the candidate's qualifications, experience, and skills. Bonus, incentive pay, equity and benefits may be provided in addition to the base compensation listed above.

In accordance with Massachusetts law, Vericel provides the pay range that it reasonably and in good faith expects to pay for a particular and specific employment position at the time of posting or offer. This range is subject to change based on business needs, market conditions, and individual qualifications. Employees and applicants may request the pay range for their position or for a position to which they are applying. Retaliation for making such a request is strictly prohibited.

EEO Statement

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.