Senior Scientist, Precision Medicine - Contractor at Kura Oncology

San Diego, California, United States -

Full Time

Start Date

Immediate

Expiry Date

08 Jan, 26

Salary

120.0

Posted On

11 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Molecular Biology, Genomics, Biomarker Testing, Diagnostic Development, NGS, PCR, ctDNA, MRD Detection, Regulatory Submissions, Clinical Trials, Cross-Functional Collaboration, Data Analysis, Assay Validation, Technical Oversight, Vendor Management, GCP Compliance

Industry

Biotechnology Research

Description

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 Senior Scientist to join our Precision Medicine team and play a pivotal role in advancing our 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 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. 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. 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. The hourly rate for a Senior Scientist Contractor is $100-$120 per hour. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. 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. If you are a California resident, please see the attached Privacy Notice CA Privacy Notice

Responsibilities

The Senior Scientist will lead the execution of Companion Diagnostic programs and manage the operational and scientific aspects of diagnostic development. This includes assay validation, vendor oversight, regulatory preparation, and clinical trial integration.