FUNCTIONAL AREA:
Precision Medicine (Clinical Biomarker and Companion Diagnostics)

WORK LOCATION:
San Diego, California or West Coast or Remote

ESSENTIAL JOB FUNCTIONS

· Lead the execution of feasibility and validation studies of analytical assays and methodologies to support biomarker analysis and interpretation to meet clinical objectives.
· Ensure “fit-for-purpose” biomarker datasets are generated to inform clinical development and decision-making.
· Manage the biosample inventory from various Kura’s Clinical Trial studies and arrange transfer of samples from central CROs to external partners for biomarker analysis.
· Perform comprehensive data analysis to identify biomarkers associated with clinical outcomes and therapeutic efficacy. Prepare reports and presentations to communicate results and findings to Precision Medicine stakeholders.
· Operationalize biomarker strategies for clinical study including sample set up, collection scheme, shipping from clinical sites to central CRO labs, storage and ensuring accurate testing at third partner CROs.
· Work closely with internal teams (e.g., clinical operations, biomsample management, data management,) to ensure seamless integration of exploratory biomarker data into clinical development programs.
· Liaise with external partners, including CROs and academic institutions, to facilitate biomarker study execution and data sharing.
· Support the development and approval of companion diagnostics by contributing to samples logistics and maintaining study related documentation for Kura’s internal Precision Medicine processes.

Qualifications:
· PhD preferred in molecular biology, biochemistry, genetics, cancer biology with 2+ years of industry experience. MS with 5+ and BS with 8+ years’ experience in biomarker research and clinical development
· Proven experience in designing and implementing biomarker studies, including experience with clinical trial design and sample management.
· This position requires knowledge in cancer biology, broad technical expertise, and direct experience in biomarker assay development/validation and oversight at external CROs and specialty labs.
2 / 3
· Demonstrated ability to independently design and solve scientific problems using multiple, state-of-the-art technologies, experimental methods, and approaches is required
· Previous experience of using Omics platforms (liquid biopsy preferec) and collaboration with computational biologists is a plus. Working knowledge of bioinformatic analysis, including the use of R and Python script and statistical software JMP will be beneficial in the role.
· Strong understanding of clinical trial design principles, patient sample collection, informed consent, and sample logistics. Understanding of current ICH/GxP, guidelines for genetic testing.
· Demonstrated ability to collaborate effectively with cross-functional teams and external partners.
· Experience with companion diagnostic (CDx) development is highly preferred.
· Ready to take over responsibility, and able to rapidly enter in action and to work under stress conditions independently and proactively
· Excellent communication skills, with the ability to present complex data to diverse audiences.

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