Principle Scientist, Diagnostic Development, Precision Medicine - Contractor

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.

Essential Job Functions

Kura Oncology is seeking a highly motivated Principle Scientist, Diagnostic Development to join our Precision Medicine team and play a pivotal role in advancing our biomarker and companion diagnostic (CDx) strategy across our oncology pipeline. We are seeking a Diagnostic Development Scientist to join our Precision Medicine team. This position will manage the operational and scientific aspects of diagnostic development, including assay validation, vendor oversight, regulatory preparation, and clinical trial integration. The ideal candidate will bring experience in diagnostic assay development, biomarker operations, and regulatory submissions and will thrive in a collaborative, fast-paced biotech environment where bold science meets strategic execution.

• Diagnostic Strategy & Execution
• Lead the execution of Companion Diagnostic (CDx) programs in alignment with drug development timelines.
• Drive operational readiness for global diagnostic development including U.S., EU IVDR, and Japan PMDA pathways.
• Integrate diagnostic strategy into clinical trial protocols, informed consent forms, and biosample management plans in collaboration with Clinical Development, Clinical Operations, and Regulatory Affairs.
• Manage vendor relationships, contracts, and SOWs for CDx development, retrospective/prospective biomarker testing, and ctDNA analysis.
• Technical & Scientific Oversight
• Provide scientific and technical expertise in NGS, PCR, ctDNA, MRD detection, and emerging diagnostic platforms.
• Oversee and interpret assay validation studies, troubleshoot technical challenges, and ensure assay readiness for clinical and regulatory use.
• Contribute to biomarker data analysis and interpretation in partnership with bioinformatics and translational research teams..
• External Partnerships
• Serve as the technical point of contact for diagnostic partners, CROs, and assay vendors]
• Ensure compliance with GCP, CLIA, CAP, FDA CDx guidance, and IVDR requirements.
• Facilitate data and sample transfers for regulatory submissions and clinical validation activities).
• Innovation & Landscape Awareness
• Monitor evolving diagnostic technology and regulatory landscapes to anticipate opportunities and risks.
• Explore innovative diagnostic tools and multi-analyte biomarker strategies to improve patient stratification and trial success.
• Identify opportunities to integrate ctDNA and MRD testing across programs to strengthen patient selection and monitoring.

Job Requirements

• Ph.D. (or M.S. with equivalent experience) in Molecular Biology, Pathology, Genomics, Biomedical Sciences, or related field.
• 5+ years of industry experience in diagnostic development, preferably in oncology or Precision medicine.
• Strong understanding of IVD/CDx development lifecycle, including analytical and clinical validation and regulatory frameworks (FDA, IVDR, PMDA).
• Hands-on or oversight experience with NGS-based assays, ctDNA testing, IHC, or other molecular diagnostic platforms.
• Experience in clinical trial design, sample management logistics, and diagnostic lab operations.
• Proven ability to work cross-functionally in a fast-paced, collaborative biotech environment.
• Strong written and verbal communication skills; ability to clearly interpret and present complex scientific and operational data.

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
• 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!

Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Company's pipeline consists of small molecule drug candidates designed to target cancer signaling pathways. Ziftomenib, a once-daily, oral menin inhibitor, is the first and only investigational therapy to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration ("FDA") for the treatment of relapsed/refractory ("R/R") NPM1-mutant acute myeloid leukemia ("AML"). In November 2024, Kura Oncology entered into a global strategic collaboration agreement with Kyowa Kirin Co., Ltd. to develop and commercialize ziftomenib for AML and other hematologic malignancies. Enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1-mutant AML has been completed, and in the second quarter of 2025, the companies announced the FDA's acceptance of a New Drug Application for ziftomenib for the treatment of adult patients with R/R NPM1-mutant AML and assignment of a Prescription Drug User Fee Act target action date of November 30, 2025. Kura Oncology and Kyowa Kirin are also conducting a series of clinical trials to evaluate ziftomenib in combination with current standards of care in newly diagnosed and R/R NPM1-mutant and KMT2A-rearranged AML. KO-2806, a next-generation farnesyl transferase inhibitor, is being evaluated in a Phase 1 dose-escalation trial as a monotherapy and in combination with targeted therapies for patients with various solid tumors. Tipifarnib, a potent and selective farnesyl transferase inhibitor, is currently in a Phase 1/2 trial in combination with alpelisib for patients with PIK3CA-dependent head and neck squamous cell carcinoma. For additional information, please visit Kura's website at www.kuraoncology.com and follow us on X and LinkedIn.

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.

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