Kura Oncology
Senior Scientist, Precision Medicine - Contractor
Kura Oncology, San Diego, California, United States, 92189
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.
We are building a leading biotech organization with 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 demonstrate excellence in drug discovery and development and a roll-up-your-sleeves attitude. The ideal candidate will bring 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 Senior Scientist to join our Precision Medicine team and advance biomarker and companion diagnostic (CDx) testing programs across our oncology pipeline. 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 have 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. Biomarker and Diagnostic Plan Implementation
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. Maintain diagnostic vendor oversight for CDx development, central biomarker testing for patient enrollment, and ctDNA analysis. Author biomarker and diagnostic sections of clinical trial protocols, ICFs, and biomarker management plans, aligning diagnostic implementation with precision medicine strategy. Collaborate cross-functionally with Clinical Development, Regulatory, and Clinical Operations, external partners to align biomarker/CDx strategy to global registration pathways (FDA, IVDR, PMDA). 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. Identify opportunities to integrate ctDNA and MRD testing across programs to strengthen patient selection and monitoring. External Partnerships
Serve as the technical point of contact for diagnostic partners, CROs, and assay vendors. Ensure testing compliance with GCP, CLIA, CAP, FDA CDx guidance, and IVDR requirements. Facilitate data and sample transfers for regulatory submissions and clinical validation activities. Job Requirements
Ph.D. (or M.S. with equivalent experience) in Molecular Biology, Pathology, Genomics, Biomedical Sciences, or related field. Ph.D. with 5+ years of industry experience or MS with 8+ years with biomarker testing and diagnostic development in pharma/biotech setting, 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 documentation authoring, 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. The hourly rate for a Senior Scientist Contractor is $100-$120 per hour. Kura’s Values and Benefits
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 Competitive compensation package, bonus, 401K + employer contributions, generous stock options, ESPP 20 days of PTO to start + 18 holidays Generous benefits with substantial employer match Paid parental leave, in-office catered lunches, home office setup, lifestyle stipend, commuter stipend (Boston office) Kura Oncology is a clinical-stage biopharmaceutical company focused on precision medicines for cancer. For more information, visit www.kuraoncology.com and follow us on X and LinkedIn. Kura Oncology is 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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Kura Oncology is seeking a highly motivated Senior Scientist to join our Precision Medicine team and advance biomarker and companion diagnostic (CDx) testing programs across our oncology pipeline. 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 have 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. Biomarker and Diagnostic Plan Implementation
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. Maintain diagnostic vendor oversight for CDx development, central biomarker testing for patient enrollment, and ctDNA analysis. Author biomarker and diagnostic sections of clinical trial protocols, ICFs, and biomarker management plans, aligning diagnostic implementation with precision medicine strategy. Collaborate cross-functionally with Clinical Development, Regulatory, and Clinical Operations, external partners to align biomarker/CDx strategy to global registration pathways (FDA, IVDR, PMDA). 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. Identify opportunities to integrate ctDNA and MRD testing across programs to strengthen patient selection and monitoring. External Partnerships
Serve as the technical point of contact for diagnostic partners, CROs, and assay vendors. Ensure testing compliance with GCP, CLIA, CAP, FDA CDx guidance, and IVDR requirements. Facilitate data and sample transfers for regulatory submissions and clinical validation activities. Job Requirements
Ph.D. (or M.S. with equivalent experience) in Molecular Biology, Pathology, Genomics, Biomedical Sciences, or related field. Ph.D. with 5+ years of industry experience or MS with 8+ years with biomarker testing and diagnostic development in pharma/biotech setting, 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 documentation authoring, 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. The hourly rate for a Senior Scientist Contractor is $100-$120 per hour. Kura’s Values and Benefits
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 Competitive compensation package, bonus, 401K + employer contributions, generous stock options, ESPP 20 days of PTO to start + 18 holidays Generous benefits with substantial employer match Paid parental leave, in-office catered lunches, home office setup, lifestyle stipend, commuter stipend (Boston office) Kura Oncology is a clinical-stage biopharmaceutical company focused on precision medicines for cancer. For more information, visit www.kuraoncology.com and follow us on X and LinkedIn. Kura Oncology is 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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