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.
What You Will Do:
Clinical Trial Execution & Program Ownership
- 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
Vendor & CRO Management
- 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
Cross-Functional Program Leadership
- 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
Operational Planning & Infrastructure
- 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
Quality, Compliance & Inspection Readiness
- 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
Team Leadership & Development
- 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
What You Will Bring:
- 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
- Skilled at balancing strategic thinking with hands-on execution
- Excellent communication and cross-functional influence
- Proactive problem solver with a focus on delivering results