Senior Clinical Trial Leader

About the position

Are you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines? At Kura Oncology, you have an opportunity to be a part of something bigger, with a lasting impact that you can be proud of. At Kura Oncology, we are working to change the paradigm and improve the science of cancer treatment. As an organization, we strive to cultivate a diverse and talented professional culture driven to develop precision medicine therapeutics. As we continue to build a leading biotech organization with a strong culture, a patient-focused mindset and a team focused on relentless execution, we are looking for innovative, passionate professionals to join us and make our vision a reality. To succeed at Kura, you will need to have a demonstrated ability for excellence in drug discovery and development and a roll-up your sleeves attitude. The ideal candidate will possess a values-driven work style where integrity and grit drive all behaviors, decisions, and actions.

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.
• Accountable for coordination of 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 provide input into study-related documents, including ICFs, CRFs, monitoring plans, study, lab and pharmacy manuals, data management plans, etc.
• Perform review and provide strong operational input in the development of clinical trial protocols and CSRs.
• Contribute to department documentation development, such as the development and writing of Standard Operating Procedures (SOPs).
• Collaborate with Legal & Clinical Contracting & Outsourcing on the development and management of study specific agreements/budgets.
• Organize and manage project timelines and budgets; help ensure project deliverables are on time and within budget and amended accordingly.
• Provide leadership and contribute to all operational aspects of the trial budget, including forecasts to ensure delivery within the business financial standards.
• Oversee the conduct of studies and ensure studies are implemented according to the study protocols and in compliance with local, ICH, GCP and company policies and procedures.
• Monitor and visit clinical study sites as needed.
• Track, collect, and review clinical documentation for clinical trials.
• Complete other duties as assigned by the manager.
• Key contributor to the development of annual trial/project objectives and communicating to relevant line management and Clinical Strategy Team (CST).
• Serve as the key CST point of contact for the trial.
• Accountable for the successful preparation and presentation of operational content at key leadership discussions.
• Ensure strong oversight, review, and delivery of trial/project CAPAs in order to meet corporate compliance standards and timelines.
• Accountable for partnering with CRO in audit responses and addressing quality issues.
• Filter, prioritize, analyze, and validate complex and dynamic information from a diverse range of external and internal sources to respond to technical operational and organizational challenges.
• Ensure inspection readiness application for all assigned clinical trials.
• Manage projects/work streams with high complexity, risk, impact, and reach.
• Manage large-sized global clinical teams with members also from outside the direct working environment.
• Coordinate stakeholders from closely related areas and beyond.
• Demonstrate skills in successfully leading international teams in the matrix organization and directs, influences, and motivates people.
• Develop and lead operational and therapeutic area training for internal and external study team members.
• Direct multiple studies in parallel and/or be called upon for program management duties.
• Exhibit Subject Matter Expert level understanding of multiple functions and functional processes.
• Accountable for successful project execution including definition of milestones and clarification of project scope.
• Receive minimal guidance and work independently.
• Act as a senior advisor and mentor within the team and beyond.

Requirements

• 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.
• 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.

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.
• Lifestyle Spending Stipend.
• Commuter Stipend (Boston Office).
• Regular employee social activities, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and much more!