Clinical Trial Leader

Boston, MA

About Kura Oncology

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.

Clinical Trial Leader

We’re looking for an innovative Clinical Trial Leader to join our team. This position will be based in Boston, MA and report to the Director, Clinical Operations.

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 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.
  • Complete other duties as assigned by the manager.

Job Requirement:

  • Minimum B.A./B.S. degree in the science/healthcare field, a nursing degree, or equivalent combined education.
  • 5+ years of experience and demonstrated success in managing complex clinical research/trials. Some experience in oncology preferred.
  • Experience in CRO oversight is required.
  • 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.

Kura’s Values that are used for candidate selection and performance assessments:

  • We work as one for patients
  • We are goal-focused and deliver with excellence
  • We are science-driven courageous innovators
  • We strive to bring out the best in each other and ourselves

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 has offices in San Diego, California, and Boston, Massachusetts.

Kura’s pipeline consists of Tipifarnib and KO-539. Tipifarnib is a farnesyl transferase inhibitor that recently received Breakthrough Therapy Designation (BTD) for the treatment of patients with certain head and neck cancers that carry HRAS mutations. Tipifarnib will also be evaluated in combination with an inhibitor of PI3Kalpha to treat between 20-50% of patients with HNSCC, the 7th largest cancer worldwide. KO-539 is an inhibitor of the menin/MLL interaction, which is are critically important for survival, growth, and proliferation leukemic blasts. Kura recently presented preliminary clinical data for KO-539 at the 2020 American Society of Hematology (ASH) meeting that demonstrated that it demonstrates favorable safety and tolerability and compelling evidence of activity in genetically defined AML patients.

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.