Biomarker Clinical Assay Lead, Principal Scientist (Translational)

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Job Title: Biomarker Clinical Assay Lead, Principal Scientist (Translational)

Background

RayzeBio is a dynamic biotechnology company headquartered in San Diego, CA. Launched in late 2020 and recently acquired by Bristol Myers Squibb (BMS) as a wholly owned subsidiary, the company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio will operate as a standalone entity within the BMS organization, maintaining its biotech culture with the opportunity to leverage the best-in-class oncology capabilities of BMS. RayzeBio is developing innovative drugs against targets of solid tumors. The lead asset, RYZ101, is in Phase 3 testing for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs), as well as earlier stage testing for patients with small cell lung cancer (SCLC).  Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.

Job Description

As a Biomarker Clinical Assay Lead within the Translational team, you will be working closely with the Clinical teams to collect and analyze critical biomarker data to advance novel Radiopharmaceutical Oncology therapies. You will play a crucial role in supporting study teams by providing scientific oversight, managing clinical vendors, and overseeing data integrity and quality of biomarker analyses in support of clinical development strategies. The ideal candidate will be an experienced, accomplished biomarker lead scientist with outstanding interpersonal and communication skills. The position will require an ability to work effectively in interdisciplinary team settings. The role requires an ability and willingness to work with radioactive isotopes.

Job Responsibilities

Essential duties and responsibilities include the following.  Other duties may be assigned.

• Provide technical and operational expertise in biomarker bioanalytical assays to Study Teams to ensure high-quality clinical biomarker data delivery.
• Collaborate with Study Teams and Clinical Operations to ensure proper biomarker sample handling and processing procedures are outlined in the clinical trial Laboratory Manual.
• Lead novel assay development and timely availability of fit-for-purpose oncology clinical biomarker assays to clinical Study Teams.
• Address and resolve complex technical and logistical challenges at vendor sites.
• Critically evaluate complex data, identifying anomalies, trends, and guiding the team in interpreting data within a broader context.
• Serve as the primary point of contact for external commercial or academic clinical laboratories, overseeing agreements, work plans, budgets, invoices, assay transfers, assay validation, sample analyses, data transfers, and overall data quality.
• Lead and provide technical support for the selection, qualification, and periodic audits of CRO laboratories supporting clinical trial biomarker assays.
• Contribute to the selection and development of biomarker CRFs; lead the development of data transfer processes with internal and external biomarker laboratories and the internal data management team.
• Lead and contribute to the continuous improvement of best practice processes and templates. Spearhead and guide sub-teams or initiatives aimed at enhancing efficiency. Provide strategic direction for internal, cross-functional, and external continuous improvement efforts.
• Stay current with advances in biomarker assay technologies, clinical laboratory standards, regulatory guidelines (e.g., GLP, GCLP), and compliance requirements.
• Provide expertise and guidance to colleagues within the organi