Kura Oncology, Inc.
Senior Scientist, Precision Medicine - Contractor
Kura Oncology, Inc., San Diego, California, United States, 92189
Overview
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. We are changing the paradigm and improving the science of cancer treatment, cultivating a diverse and talented professional culture driven to develop precision medicine therapeutics. To succeed at Kura, you will need to demonstrate excellence in drug discovery and development and a roll-up-your-sleeves attitude. The ideal candidate will have a values-driven work style where integrity and grit drive all behaviors, decisions, and actions. Senior Scientist contractors play a pivotal role in advancing our biomarker and companion diagnostic (CDx) testing programs across our oncology pipeline. The position manages 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. Responsibilities
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). 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. 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. Qualifications
Ph.D. (or M.S. with equivalent experience) in Molecular Biology, Pathology, Genomics, Biomedical Sciences, or related field. PhD 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. Compensation and Benefits
Hourly rate for Senior Scientist Contractor is $100-$120 per hour; base varies by skills, experience, location, and education. Career advancement/development opportunities Competitive compensation package, bonus, 401K + employer contributions, and generous stock options ESPP Plan, 20 days of PTO to start, 18 holidays, substantial benefits package with employer match Paid parental leave, in-office catered lunches, home office setup, lifestyle stipend Commuter stipend (Boston Office) and regular employee social activities Kura Oncology is a clinical-stage biopharmaceutical company focused on precision medicines for cancer. Its pipeline includes ziftomenib, a menin inhibitor, with notable collaboration and regulatory progress described on the company website. Kura is committed to creating a diverse environment and is an equal opportunity employer. All qualified applicants will receive consideration 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 CA Privacy Notice.
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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. We are changing the paradigm and improving the science of cancer treatment, cultivating a diverse and talented professional culture driven to develop precision medicine therapeutics. To succeed at Kura, you will need to demonstrate excellence in drug discovery and development and a roll-up-your-sleeves attitude. The ideal candidate will have a values-driven work style where integrity and grit drive all behaviors, decisions, and actions. Senior Scientist contractors play a pivotal role in advancing our biomarker and companion diagnostic (CDx) testing programs across our oncology pipeline. The position manages 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. Responsibilities
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). 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. 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. Qualifications
Ph.D. (or M.S. with equivalent experience) in Molecular Biology, Pathology, Genomics, Biomedical Sciences, or related field. PhD 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. Compensation and Benefits
Hourly rate for Senior Scientist Contractor is $100-$120 per hour; base varies by skills, experience, location, and education. Career advancement/development opportunities Competitive compensation package, bonus, 401K + employer contributions, and generous stock options ESPP Plan, 20 days of PTO to start, 18 holidays, substantial benefits package with employer match Paid parental leave, in-office catered lunches, home office setup, lifestyle stipend Commuter stipend (Boston Office) and regular employee social activities Kura Oncology is a clinical-stage biopharmaceutical company focused on precision medicines for cancer. Its pipeline includes ziftomenib, a menin inhibitor, with notable collaboration and regulatory progress described on the company website. Kura is committed to creating a diverse environment and is an equal opportunity employer. All qualified applicants will receive consideration 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 CA Privacy Notice.
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