Biomarker Manager

San Diego, CA

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.

Biomarker Scientist

We’re looking for an innovative Biomarker Scientist to join the clinical development team and report to the Senior Director, Diagnostics. This is a newly created position due to growth.

The Biomarker Scientist will provide day to day oversight, support, and program management for biomarker and diagnostic projects for the Kura Oncology precision oncology pipeline. This position will collaborate with both external biomarker and diagnostic service providers and internal Kura stakeholders to bring precision medicines to patients with both solid and liquid tumors. The scientist will assist in managing the development, outsourcing, and validation of clinically applicable biomarker testing and diagnostic assays.

Essential Job Functions:

  • Manage lifecycle of patient tumor samples for biomarker testing for multiple clinical trial in solid and liquid tumors:
    • Sample collection at study sites, central lab testing, and storage for companion diagnostic development
    • Utilize tracking systems to monitor and report project progress such that sample data can be accurately summarized for the Manager and allow for proactive escalation of testing issues related to biomarkers and/or diagnostic technologies to the Manager
    • Serve as the point person to support Kura’s Clinical Operations and Data Management teams on requests related to samples for biomarker testing and obtain technical and regulatory input from other Diagnostic Team members when needed
  • Support Diagnostics Team on contracts, budgets, project, and development timelines and work closely with the Kura Finance and Project Management Team to ensure that information is accurately captured. Actively participate in Joint Project Team calls with biomarker and diagnostic vendors and ensure that the meeting minutes are captured appropriately, including all action items.
  • Invite and process work proposals for Kura’s diagnostic projects and biomarker testing.  Be the point person for obtaining proposals, work orders, statements of works, etc. from diagnostic and biomarker testing vendors based on the technical and regulatory needs related to the testing. Utilize technical and clinical insights to source the appropriate biospecimens for assay validation activities.
  • Support the biomarker testing and companion diagnostic strategies in accordance with the requirements of quality, ethical, and regulatory standards, including ICH/GDPR/GCP/GLP/CLIA.
  • Assist clinical operations in preparing and reviewing Laboratory Manual according to patient testing and assay requirements.
  • Additional responsibilities:
    • Manage Diagnostics team meetings as well as minutes, agendas, action items, etc.
    • Prepare PowerPoints summarizing progress for Senior Leadership.
    • Provide support for all activities involving start-up execution and close-out of all contracts, budgets, and timelines.
    • Liaison between Kura’s finance and external partners for invoicing, payments, and monthly percent completion of Kura’s projects.
    • Bring issues to Manager or Program team’s as necessary and participate in the resolution of delays or potential delays.
    • Respond to changing duties as responsibilities may vary based on potential pipeline growth, project needs, and stages of development (pre-clinical, clinical or commercial).

Job Requirements

  • BS or MS with 2-4 years minimum hands-on work experience in drug development, cancer diagnostics, or clinical trial management.
  • Direct experience with tumor sample management and/or biomarker testing in Phase 1-3 clinical trials required.
  • Working knowledge of informed consent language for sample collection preferred.
  • Experience with Microsoft Office, including Excel, required. Experience with Microsoft Project as well as other database and timeline management software preferred but not essential.
  • High level of integrity, accuracy, and attention to detail.
  • Self-organized, self-directed, highly motivated with strong critical thinking and analytical skills.
  • Willingness to work collaboratively, think critically, and incorporate diverse perspectives into decision-making.
  • Demonstrated ability to work successfully in a nimble, fast-paced matrixed environment.
  • Outstanding interpersonal, communication, and negotiation skills.

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 when working onsite
  • 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.