Director/Sr. Director, Clinical Operations

About the role

Kelonia Therapeutics is a clinical company dedicated to viral engineering and in vivo lentiviral gene and cell therapy. Our mission is to bring the promise of cell and gene therapy to every patient in need. We are led by a team of pioneering scientists who provide cutting-edge technology.

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
• Partner with VP and cross-functional stakeholders on vendor selection and governance
• Act as the primary escalation point for operational challenges

Requirements

• Bachelor’s degree in life sciences or related field; advanced degree preferred with 10+ years (Director) / 12+ years (Senior Director) in clinical operations
• Demonstrated experience leading early-phase oncology clinical trials (Phase I/II)
• Experience in hematological malignancies and cell and gene therapy strongly preferred
• 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
• Excellent communication and cross-functional influence
• Proactive problem solver with a focus on delivering results

Qualifications

• Must be able to work in the United States
• Must be legally authorized to work in the United States without company sponsorship now or in the future

Skills

• Strong leadership and project management skills
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team
• Strong analytical and problem-solving skills
• Knowledge of clinical trial regulations and guidelines

Benefits

• Flexible Time Off
• Flexible Scheduling
• Competitive Benefits Package (health, commuter, etc.)
• On-site Perks (free parking, gym, food hall)

Pay

• $190,000 - $252,000 a year (Director)
• $228,000 - $286,000 a year (Sr. Director)

Schedule

• Flexible