Kelonia Therapeutics

Medical Director

• Support clinical development activities across 1–2 oncology programs, including supporting our lead clinical program KLN-1010
• Perform ongoing medical review of clinical data, including safety, efficacy, and patient-level insights
• Contribute to and progressively lead key clinical deliverables, including:
• - Clinical study protocols and amendments
• - Investigator’s Brochures
• - Clinical study reports and medical summaries
• - Regulatory submission documents (e.g., INDs, briefing materials)
• Partner closely with Clinical Operations, Regulatory, Biometrics, and Translational teams to support high-quality study execution
• Participate in medical monitoring and safety review activities
• Support regulatory submissions and interactions, including preparation of FDA-facing materials, and pharmacovigilance reporting
• Engage with investigators and clinical sites to support trial conduct and enrollment
• Contribute to clinical strategy discussions, with increasing ownership as experience grows

Medical Director, Clinical Development

Clinical Research

• Support day-to-day medical monitoring, clinical development, data services, and pharmacovigilance for lead programs
• Collaborate cross-functionally with Clinical Operations, Regulatory, Biometrics, Translational Sciences, and Medical teams to ensure high-quality and timely study execution
• Perform ongoing review and interpretation of clinical data, including safety, efficacy, and longitudinal patient data
• Act as a primary contributor and owner of key clinical deliverables, including: Clinical study protocols, Investigator’s Brochures, Clinical study reports, and Regulatory submission documents
• Support clinical trial conduct and oversight, including data review, issue identification, and resolution
• Contribute to regulatory interactions and submissions, including preparation of FDA-facing materials and global regulatory documentation
• Partner with Clinical Operations to support patient enrollment strategy and execution

Director, Clinical Scientist

Clinical Operations

• 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, and CMC / Manufacturing
• Ensure seamless communication of timelines, risks, and decisions across teams
• Build and implement study-level processes, tools, and tracking mechanisms
• Contribute to the development of broader clinical operations infrastructure in partnership with the VP
• 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
• 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

Medical Director, Clinical Development

Director, Clinical Scientist

Director/Sr. Director, Clinical Operations