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 organization.

Education and Experience

• PhD or PharmD with 4+ years of industry or clinical laboratory experience in Oncology biomarker assay development, assay validation, and implementation within clinical trials employing a broad range of platform technologies (e.g., NGS, IHC, PCR, FISH, flow cytometry, other cell based and circulating biomarker technologies) OR
• MS with 6+ years of industry or clinical laboratory experience in Oncology biomarker assay development, assay validation, and implementation within clinical trials employing a broad range of platform technologies (e.g., NGS, IHC, PCR, FISH, flow cytometry, other cell based and circulating biomarker technologies) OR
• BS with 8+ years of industry or clinical laboratory experience in Oncology biomarker assay development, assay validation, and implementation within clinical trials employing a broad range of platform technologies (e.g., NGS, IHC, PCR, FISH, flow cytometry, other cell based and circulating biomarker technologies)
• Extensive knowledge of clinical laboratory regulatory and compliance requirements (e.g., GCLP, CAP, CLIA) for fit for purpose biomarker assay oversight within oncology clinical trials.
• Strong verbal and written communication skills

Preferred Qualifications

• Experience with clinical or companion diagnostics
• Extensive CRO management and outsourcing engagement experience
• Experience with Oncology specialty platforms, Molecular Oncology, or Hematopathology
• Clinical Lab Science (CLS) or American Society of Clinical Pathologist (ASCP) certification
• Strong track record of publications and/or conference presentations demonstrating recognized subject matter expertise in one or more of these areas: IHC, multiplex immunoassay technologies, and Molecular Oncology (NGS) assays
• Creativity and adaptability to explore new research methodologies, technologies, and approaches that enhance translational research outcomes.
• Ability to work collaboratively with clinicians, researchers, bioinformaticians, and other stakeholders to integrate diverse perspectives and advance translational research goals.
• Excellent written and oral communication and presentation skills and ability to work in a fast-paced, dynamic, and collaborative environment.
• Strong interpersonal, organizational and communication skills.
• Prior experience as a project leader or functional leader on interdisciplinary team is critical.
• Ability to work with radioisotopes with strict adherence to radiation safety protocols.
• Ability to successfully establish and manage external collaborations including CROs and academic and industrial partnerships.

Physical Demands:

While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 30 pounds. Specific vision abilities required by this job include close vision and distance vision.

This is a position that requires working in a laboratory environment, protective clothing, gloves, and safety glasses are required while working in a laboratory environment with radioactive materials.

Work Environment:

The noise level in the work environment is usually moderate.

The starting compensation for this job is a range from $148,000 - $179,300 plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

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If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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