Clinical Trial Leader/Senior CTL, Clinical Operations

Boston, MA

Are you ready to join a team committed to making a meaningful impact through precision medicine? By joining Kura, 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 hold precision medicine to a high standard, applying cutting-edge science to create a more personalized approach in the treatment of cancer. We’ve changed the paradigm and improved the science of cancer treatment. We strive to cultivate a diverse and talented professional culture driven to develop therapies and solutions that are as unique as all of us.

As we continue to build a leading biotech organization with a strong culture, relentless execution, and a patient-focused mindset, Kura is planning to grow another 25% this year. To that end, we’re looking for our next innovator to join and help make our vision a reality. To take smart risks in pursuing novel areas of drug research and development and have fun along the way.

To succeed at Kura, you need to have a demonstrated reputation for putting the patient first and foremost, 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.

ESSENTIAL JOB FUNCTIONS:

  • 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.
  • Oversee all operational activities to ensure deliverables are prioritized and goals and objectives are met and/or changed accordingly.
  • Accountable for coordination of planning, initiation, completion, and reporting of clinical protocols within or across programs from team endorsement to reporting.
  • Ensure clinical trials meet the time, quality, and cost targets consistent with the overall Clinical Development Plan.
  • Lead the development of and provide input into study-related documents, including clinical protocols, ICFs, CRFs, monitoring plans, study, lab and pharmacy manuals, data management plans, etc.
  • Contribute to department documentation development, such as the development and writing of Standard Operating Procedures (SOPs).
  • Collaborate with legal (and others, as needed) on the development and management of study-specific agreements (i.e. non-disclosure agreements, clinical trial agreements, clinical research organization agreements, etc.)
  • Organize and manage project timelines and budgets; help ensure project deliverables are on time and within budget and amended accordingly.
  • 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.

JOB SPECIFICATIONS:

  • Minimum B.A./B.S. degree in the science/healthcare field, a nursing degree, or equivalent combined education.
  • At least 5 years of clinical research/trial experience or relevant work in the pharmaceutical/biopharma industry. Some experience in oncology preferred.
  • Experience in CRO oversight is preferred.
  • 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 the time.

THE KURA PACKAGE

  • Career advancement/ development opportunities
  • Competitive comp package
  • Bonus
  • 401K + employer contributions
  • Generous stock options
  • ESPP Plan
  • 20 days of PTO to start
  • 14 Holidays + 3 Floater Holidays (Including Winter Break), Summer Hours
  • 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
  • Cell Phone and Wellness Stipend
  • Commuter Stipend (Boston Office)
  • Regular employee social activities, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and much more!

Kura Oncology is a clinical-stage biopharmaceutical company discovering and developing personalized therapeutics for the treatment of solid tumors and blood cancers. The company’s diverse pipeline consists of small molecules that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes by identifying those patients most likely to benefit from treatment. Kura Oncology’s approach to drug development is focused on rapidly translating novel science into life-saving medicines. Our goal is to help patients with cancer lead better, longer lives. Kura Oncology was founded in 2014 and has offices in San Diego, California, and Boston, Massachusetts.

Kura’s pipeline consists of Tipifarnib and KO-539. Tipifarnib is a farnesyl transferase inhibitor currently being evaluated in patients with certain head and neck cancers that carry HRAS mutations. KO-539 is an oral investigational drug candidate we are developing for the treatment of genetically defined AML patients with high unmet needs, currently in a Phase 1/2A clinical trial. KO-539 blocks the interaction of two proteins called menin and MLL that, together, are critically important for survival, growth, and proliferation of certain kinds of leukemia cells.

Kura Oncology is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. To apply, please submit your resume to careers@kuraoncology.com