Kura Oncology
Principle Scientist, Diagnostic Development, Precision Medicine - Contractor
Kura Oncology, San Diego, California, United States, 92189
Overview
Principle Scientist, Diagnostics Development, Precision Medicine - Contractor role at Kura Oncology. The position supports the Diagnostics and Precision Medicine team to advance biomarker and companion diagnostic (CDx) strategy across the oncology pipeline. The candidate will manage operational and scientific aspects of diagnostic development, including assay validation, vendor oversight, regulatory preparation, and clinical trial integration. The ideal candidate has experience in diagnostic assay development, biomarker operations, and regulatory submissions, and thrives in a collaborative, fast-paced biotech environment. To succeed, candidates should demonstrate excellence in drug discovery and development and a roll-up-your-sleeves attitude, with a values-driven work style where integrity and grit guide decisions and actions. Responsibilities
Diagnostic Strategy & Execution Lead the execution of 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 statements of work 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. Qualifications
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
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
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 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 and more Kura Oncology is a clinical-stage biopharmaceutical company committed to precision medicines for cancer. The company’s pipeline includes ziftomenib (menin inhibitor) and other programs. For more information, visit 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. If you are a California resident, please see the attached Privacy Notice.
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Principle Scientist, Diagnostics Development, Precision Medicine - Contractor role at Kura Oncology. The position supports the Diagnostics and Precision Medicine team to advance biomarker and companion diagnostic (CDx) strategy across the oncology pipeline. The candidate will manage operational and scientific aspects of diagnostic development, including assay validation, vendor oversight, regulatory preparation, and clinical trial integration. The ideal candidate has experience in diagnostic assay development, biomarker operations, and regulatory submissions, and thrives in a collaborative, fast-paced biotech environment. To succeed, candidates should demonstrate excellence in drug discovery and development and a roll-up-your-sleeves attitude, with a values-driven work style where integrity and grit guide decisions and actions. Responsibilities
Diagnostic Strategy & Execution Lead the execution of 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 statements of work 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. Qualifications
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
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
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 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 and more Kura Oncology is a clinical-stage biopharmaceutical company committed to precision medicines for cancer. The company’s pipeline includes ziftomenib (menin inhibitor) and other programs. For more information, visit 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. If you are a California resident, please see the attached Privacy Notice.
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