Senior Clinical Trial Leader

Role Summary

Senior Clinical Trial Leader at Kura Oncology. Responsible for planning and managing the operational aspects of clinical trials, ensuring milestones and deliverables align with program and company goals. Leads collaboration across internal and external teams, maintains compliance with GCP/ICH and company policies, and oversees study documentation, budgets, and trial readiness.

Responsibilities

• Responsible for the planning and management of the operational aspects of clinical trials, including CRO and vendor management/oversight, ensuring project milestones and objectives are met and clinical study deliverables are consistent with program/company goals.
• Collaborate with internal and external team members for the planning and execution of clinical trials.
• Coordinate planning, initiation, completion, and reporting of clinical study protocols within or across programs from team endorsement to reporting.
• Ensure clinical trials meet time, quality, and cost targets consistent with the overall Clinical Development Plan.
• Lead the development of and input into study-related documents (ICFs, CRFs, monitoring plans, manuals, data management plans, etc.) and provide operational input in protocols and CSRs.
• Contribute to SOP development and department documentation.
• Collaborate on study-specific agreements/budgets (NDAs, CTAs, CRO agreements, etc.).
• Organize and manage project timelines and budgets; ensure deliverables are on time and within budget.
• Provide leadership for the trial budget, including forecasts to meet financial standards.
• Oversee study conduct, ensuring compliance with protocols and local, ICH, GCP and company policies.
• Monitor and visit clinical study sites as needed; track and review clinical documentation.
• Complete other duties as assigned; contribute to annual trial/project objective development and CST communications.
• Serve as the key CST point of contact for the trial; prepare and present operational content at leadership discussions.
• Ensure oversight and delivery of trial/project CAPAs to meet compliance and timelines; partner with CRO on audits and quality issues.
• Filter, prioritize, analyze, and validate complex information to respond to operational and organizational challenges; ensure inspection readiness for assigned trials.

Qualifications

• Advanced degree desirable; PM certification desirable
• Ideally 10 years clinical research experience with at least 5 years of direct trial management experience
• Some experience in oncology preferred
• Experience in CRO oversight is required
• Manages large-sized global clinical trial teams; works with minimal supervision
• Ability to mentor junior staff; self-directed and proactive with multiple complex tasks
• Strong organization, documentation, and communication skills; excellent interpersonal skills
• Detailed knowledge of GCP, ICH Guidelines and current US FDA regulations
• Ability to travel up to approximately 30% of time; hybrid on-site in Boston two days per week

Skills

• Project management and cross-functional collaboration
• Budgeting and forecasting for clinical trials
• Clinical operations leadership; CRO/vendor management
• Regulatory knowledge (GCP, ICH, FDA)
• Documentation development and SOP writing
• Problem-solving and data-driven decision making

Education

• Advanced degree desirable

Additional Requirements

• Travel up to ~30% of time