Translational Clinical Biomarker Senior Principal Scientist - Pathologist
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 Tumor Microenvironment Thematic Research Center (TME TRC) is focused on developing therapeutic targets at the intersection of tumor, stromal and immune biology within the TME with the goal of enhancing responsiveness to checkpoint blockade and targeted therapies and transforming response and durability rates for cancer patients. Comprising of scientists across multiple disciplines we are responsible for the biology and translational science necessary to support drug development from target identification through to first in human studies
We are seeking a highly motivated pathologist with deep technical and clinical trial sample analysis expertise to join the Translational Development (TD) team within the Tumor Microenvironment Thematic Research Center (TME TRC) at Bristol Myers Squibb in Redwood City, CA. This non-lab-based individual will be responsible for working with internal and external labs on assay development, validation and clinical sample review to support translational biomarker strategies and plans.
The Translational Clinical Biomarker Scientific Expert will be responsible for providing expertise in pathology as a subject matter expert and partner to Translational Development Biomarker Leads with multiple oncology programs. This is an individual contributor, non-lab-based role in Redwood City, CA. He/she will bring deep technical experience with emphasis on oncology/immuno-oncology/tumor microenvironment related biomarkers, leveraging discovery, translational research and other relevant assay information and data (e.g., pre-analytics, quality considerations). This role will provide scientific expertise in the design of assay development/plans/validations (e.g. exploratory assays such as pharmacodynamic, target engagement, mechanism of action assays), and for review of clinical sample analysis data from First in Human through Proof of concept clinical trials, working with internal and external testing lab partners and CROs.
Provide expertise for assay development and validation partnering with Translational Leads for assays to be used in clinical trials by defining appropriate acceptance criteria/quality, controls and analysis approaches (e.g. precision, assay variability, acceptance criteria, etc.) as relevant to the technology and to enable confidence in clinical trial sample analysis
Provide recommendations around technologies, reagents, troubleshooting, controls, data analysis and platforms based on the intended use of the assays in clinical trials in context of program strategies, relevant biology and assay data
Support and draft relevant documents related to assay development and validation, and assay transfers from BMS to external companies as needed for clinical trials
Participate in vendor discussions, translational sub-teams and in other relevant cross-functional collaboration
Provide pre-analytics/sample collection and logistics expertise from assay development through clinical trial sample analysis (e.g. workflows, sample quantity, stability and quality considerations and risk mitigations in collaboration with Translational Biomarker Lead and global biospecimen management lead
Collaborate with translational project management and planning team and Translational Biomarker Lead to monitor and track assay development/validation/clinical sample analysis timelines and deliverables
A significant amount of time will be spent reviewing clinical sample analysis raw data/images to ensure confidence in data for use in analysis by Translational Biomarker leads in conjunction with other clinical trial or assay data, as well as assay development and validation related data, reports and information, and in compliance with relevant BMS guidance/SOPs.
Definition of data transfer variables for data agreements and data transfer pathways in collaboration with relevant informatics teams and biostatistics teams in support of translational data analysis requirements
Share clinical sample analysis expertise, experience, lessons learned and knowledge with translational and other relevant scientific experts and colleagues across the organization as relevant, such as via mentorship and presentations
MD or MD/PhD or equivalent advanced biology degree with 8+ years of industry, preferred within oncology clinical trials
Note this role is not lab-based, but is located in Redwood City, CA, and requires significant prior experience in clinical assay development / validation and clinical trial sample analysis, preferably in pharma, biotech, contract research organization (CRO), specialty testing lab or clinical lab setting
Expertise in pathology assays relevant to the tumor microenvironment and:
Methods such as IHC (monoplex, duplex, triplex, etc.), multiplex immunofluorescence, and ISH
Platforms such as Dako, Ventana, Leica
Familiarity with relevant whole slide scanning, image analysis (including spatial profiling), algorithm development, data processing
Familiarity with analysis packages such as Halo, VisioPharm and Aperio
Expertise and demonstrated past ability to develop / validate assays and to discuss clinical sample images with external vendors, including identification and assessment of appropriate controls and monitoring of assay over time; ability to effectively cooperate and partner with external providers and others within BMS
Familiarity with clinical assay validation guidelines and guidance (diagnostics a plus)
Excellent communication skills and comfortable working in a fast-paced environment where speed is paramount
Demonstrated experience in the appropriate application of various scientific technologies into translational strategies in clinical sample analysis in various stages of clinical development.
Willing to work as a topic expert, outside of a traditional functional environment, in a team unified around supporting the assets.
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 email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.