CTL/Senior Clinical Trial Leader

About the role

Kura Oncology is a commercial-stage biopharmaceutical company dedicated to discovering and developing innovative precision medicines to help patients with cancer. We focus on understanding the underlying causes of treatment resistance and designing smart combination regimens to improve long-term clinical benefit.

Responsibilities

• Plan and manage operational aspects of clinical trials, including CRO and vendor management/oversight.
• Coordinate planning and execution of clinical trials.
• Ensure clinical trials meet time, quality, and cost targets consistent with the Clinical Development Plan.
• Develop and provide input into study-related documents, including ICFs, CRFs, monitoring plans, study, lab and pharmacy manuals, data management plans, etc.
• Contribute to department documentation development, such as SOPs.
• Manage project timelines and budgets; ensure project deliverables are on time and within budget.
• Lead the development of and provide input into study-specific agreements and budgets.
• 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.
• Prepare and present operational content at key leadership discussions.
• Partner with CRO in audit responses and address quality issues.
• Manage projects/work streams with high complexity, risk, impact, and reach.
• Manage large-sized global clinical teams with members from outside the direct working environment.
• Direct, influence, and motivate people; create and lead a positive working climate.
• 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.
• Ensure successful project execution including definition of milestones and clarification of project scope.

Requirements

Advanced degree desirable; PM certification desirable. Ideal 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 team. Works with minimal or no supervision. 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. Hybrid on-site in Boston two days per week.

Qualifications

Desired: Advanced degree, PM certification, 10+ years clinical research experience, 5+ years direct trial management experience, some experience in oncology, experience in CRO oversight.

Skills

Desired: Advanced degree, PM certification, 10+ years clinical research experience, 5+ years direct trial management experience, some experience in oncology, experience in CRO oversight.

Benefits

Competitive compensation package, including base range for a CTL of $162,000 - $194,000 and a Senior CTL of $182,000 - $205,000 per year. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus. Kura's Values: We work as one for patients, we are goal-focused and deliver with excellence, we are science-driven courageous innovators, and we strive to bring out the best in each other and ourselves. Kura's Package: 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!

Pay

The base range for a CTL is $162,000 - $194,000 and a Senior CTL is $182,000 - $205,000 per year. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training.

Schedule

Hybrid on-site in Boston two days per week.