Director/Sr. Director, Clinical Operations

Kelonia Therapeutics • Boston, MA

2d • Hybrid

About The Position

Here at Kelonia Therapeutics, we aren’t just a clinical company; we’re trailblazers in viral engineering, pushing the boundaries of in vivo lentiviral gene and cell therapy. We're not just a team; we're dreamers on a mission to bring the promise of cell and gene therapy to every patient in need. We've gathered a group of pioneers in cell and gene therapy to lead our journey, with extraordinary scientific founders at the helm, providing the cutting-edge technology that sets us apart. We're not just building a company; we're cultivating a culture that values both skill and care.

Requirements

• Bachelor’s degree in life sciences or related field; advanced degree preferred
• 10+ years (Director) / 12+ years (Senior Director) in clinical operations
• Demonstrated experience leading early-phase oncology clinical trials (Phase I/II)
• Proven success managing CROs and cross-functional clinical programs
• Deep understanding of clinical trial execution, ICH-GCP, and global regulatory requirements
• Experience with clinical systems (e.g., CTMS, eTMF, EDC)
• Strong operational planning and risk management capabilities
• Experience managing study budgets and timelines
• Strong execution mindset with end-to-end ownership of deliverables
• Ability to operate effectively in a lean, ambiguous, and fast-moving environment
• Skilled at balancing strategic thinking with hands-on execution
• Excellent communication and cross-functional influence
• Proactive problem solver with a focus on delivering results

Nice To Haves

• Experience in hematological malignancies and cell and gene therapy strongly preferred

Responsibilities

• Lead the end-to-end execution of clinical trials from study start-up through close-out
• Translate clinical development strategy into actionable operational plans, timelines, and budgets
• Own study-level delivery, ensuring trials are conducted on time, within budget, and in compliance
• Identify risks early and drive mitigation strategies to maintain program momentum
• Lead day-to-day oversight of CROs and external vendors, ensuring performance, quality, and accountability
• Define and track KPIs and deliverables, escalating issues as needed
• Partner with VP and cross-functional stakeholders on vendor selection and governance
• Act as the primary escalation point for operational challenges
• Drive alignment across Clinical Development, Translational & Research, Regulatory, CMC / Manufacturing
• Ensure seamless communication of timelines, risks, and decisions across teams
• Represent clinical operations in program-level discussions and decision-making
• Build and implement study-level processes, tools, and tracking mechanisms
• Contribute to the development of broader clinical operations infrastructure in partnership with the VP
• Identify gaps in execution and proactively implement improvements
• Ensure study execution aligns with ICH-GCP, regulatory requirements, and internal SOPs
• Oversee TMF quality and completeness at the study level, ensuring inspection readiness
• Support audits and inspections in collaboration with Quality and VP Clinical Operations
• Embed a culture of proactive quality and operational excellence
• Provide direction and mentorship to clinical operations staff (e.g., CTAs, CTMs) as applicable
• Foster accountability, prioritization, and strong execution across the study team
• Contribute to hiring and scaling of the clinical operations function

Benefits

• Flexible Time Off
• flexible scheduling
• health insurance
• commuter benefits
• free parking
• state-of-the-art gym
• food hall

What This Job Offers

• Job Type: Full-time
• Career Level: Director