CTL/Senior Clinical Trial Leader

The role

This person will plan and manage the operational aspects of clinical trials, including CRO and vendor oversight. They will coordinate clinical study protocols, manage project timelines and budgets, and ensure compliance with regulations.

What you will do

• Plan and manage operational aspects of clinical trials and vendor oversight.
• Collaborate with internal and external team members for clinical trial execution.
• Coordinate planning, initiation, completion, and reporting of clinical study protocols.
• Ensure clinical trials meet time, quality, and cost targets.
• Lead development of study-related documents including ICFs, CRFs, and manuals.
• Contribute to the development of Standard Operating Procedures (SOPs).
• Manage study specific agreements and budgets with Legal and Clinical Contracting.
• Organize and manage project timelines and budgets.
• Oversee study conduct in compliance with local, ICH, GCP and company policies.
• Monitor and visit clinical study sites as needed.

Required qualifications

• Experience in CRO oversight is required
• Manages large sized global clinical trial team
• Works with minimal or no supervision
• Ability to mentor junior staff
• Self-directed and proactive handles multiple complex tasks
• Strong organization, documentation, and communication skills.
• Excellent interpersonal skills: ability to collaborate across disciplines.
• Detailed knowledge of GCP, ICH Guidelines and current US FDA regulations.
• Ability to travel up to approximately 30% of time.

Nice to have

• 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

Benefits

• Career advancement/ development opportunities
• Competitive comp package
• Bonus
• 401K + Employer contributions
• Generous stock options
• ESPP Plan
• 20 days of PTO to start
• 18 Holidays (Including Summer & Winter Break)
• Generous Benefits Package with a variety of plans available with a substantial employer match
• Paid Paternity/Maternity Leave
• In-Office Catered lunches
• Home Office Setup

About the company

Kura Oncology is a commercial-stage biopharmaceutical company committed to discovering and developing innovative precision medicines to help patients with cancer lead better, longer lives.