Job Description
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

The clinical genomics/transcriptomics scientist is responsible for helping develop genomics biomarker strategy and implement on programs. This includes but is not limited to responsibility for genomics and gene expression profiling (GEP)biomarker assay technology/ platform selection, evaluation of in-house or vendor choice per assay use requirements, development, optimization, qualification/validation and execution of biomarker analysis for BMS translational medicine and clinical programs. The scientist must have a strong background in genomics and transcriptomics and its application in clinical programs with an understanding of and experience in working with one or more disease therapeutic areas

The individual develops genomics/transcriptomics strategy for programs working with program biomarker leads, data analysis and trial operations team. The individual works on genomics/transcriptomics strategy (assay, platform) per program requirements, protocol requirements, program biology and mechanism. Assays include but are not limited to broad genomic/GEP profiling, pharmacodynamic assays, target engagement assays, predictive, prognostic assays/ technology platform development. Assay design and development: Help develop the framework for assay development, qualification/validation and timely, well planned execution of assay and clinical analysis working with cross-functional teams. Help troubleshoot assay platform, assay performance. As an individual contributor operating within a matrix organization would facilitate the design, develop, optimize genomics and genetics biomarker assays and develop and execute the qualification/validation of these assays for clinical trial assays in house and/or via external vendors

Key assay profiles likely to include NGS or PCR based gene expression systems, genotyping or variant analysis utilizing NGS or PCR or other methodologies.

Evaluation of emerging technologies and developing expertise in assay methodology.

A significant part of time will be spent assisting development and analysis of qualification/validation data. A strong understanding of assay development and fit for purpose assay validation requirements will be essential. In case of outsourced studies, the incumbent will provide subject matter expertise and oversight of assay development and execution of sample analysis at the vendor.

Drafts experimental plans, validation reports, work instructions, technology transfer documents, study summaries and SOPs.

Actively participate in internal/external collaboration, portfolio management groups and clinical study and biomarker execution teams.

Providing subject matter expertise for functional lead stakeholders as required.

Accurate record keeping of experiments and procedures

Act as a technology evangelist and help assess and onboard relevant technologies working with matrixed teams per program requirements. Work closely with data analysis teams as well as sample management and clinical operation teams on programs. Provide mentorship and leadership in the program team and smaller technology matrix teams. Work to develop a lean organization with highly efficient genomics processes and best practices.

Minimum Requirements:

M.S. with 13+ years relevant experience or 11+ years Ph.D. in molecular biology, biochemistry, chemistry or a related life science. Significant experience and subject matter expertise in genomics or GEP application for one or more BMS therapeutic areas.
Demonstrate significant work experience in clinical assay development for genomics assets preferably in a pharma, biotech or clinical lab setting.
Expertise and demonstrated ability to develop assays, , oversee assay validation inhouse or with external vendors, develop appropriate controls/ QC methodology, oversee clinical sample analysis and assay performance and help develop and deliver program genomics biomarker strategic plans. Expertise, in-depth hands on experience is expected in genomics platforms (NGS, qPCR, variant analysis platforms) for assay development, qualification/validation, troubleshooting, and reviewing run QC data. Experience with additional technologies leveraged for ctDNA analysis and GEP analysis would be desirable.
Understanding of fit for purpose genomics assay validation principles for clinical assays.
Familiarity with genomics assay validation guidelines and guidance (FDA, CAP, CLIA, ACMG, NYSDOH, global regulatory requirements for assay development).
Basic understanding of IVD quality system standards (21 CFR part 820, ISO13485) would be a plus Knowledge of clinical sample analysis regulatory and quality frameworks and guidance in the lab and at vendors (such as GCP, CLIA, CAP, and NYDOH).
Expertise in serving as subject matter expert on technology specific data structure, data analysis, data QC in working with data analysis team and biostatistics teams.
Basic understanding of IP, contracting terms and provisions
Strong organizational and collaborative skills, excellent leadership and mentoring qualities for technical team and matrixed team.
Thrive in a highly interactive, fast-paced and dynamic team environment with agility and rigor.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please 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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