Bristol Myers Squibb
Oncology Clinical Biomarker Lead, Translational Development
Bristol Myers Squibb, Princeton, New Jersey, us, 08543
Oncology Clinical Biomarker Lead, Translational Development
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. 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. Bristol Myers Squibb has pioneered the development of immuno-oncology therapies and continues to diversify in drug development for the treatment of cancers. Our world-class Translational Development organization is exploring new aspects of tumor and immune biology to create tailored, individualized treatment strategies that will offer the greatest possible benefit to patients. The Clinical Biomarker Lead role will be responsible for development and execution of translational strategies in solid tumor oncology for assigned programs. Key responsibilities of this role are to act as a lead scientist to implement and deliver on biomarker strategies for clinical programs, develop reports and publications on translational data generated to support asset development and contribute to regulatory submissions. Professional Skills In-depth understanding of solid tumor oncology with knowledge of current and evolving clinical landscape and competitive scenarios Strong scientific background with understanding of clinical, translational, and mechanistic data with proven track record of publications Understanding of early or late-stage drug and translational development process; including experience with implementing a biomarker strategy Clinical protocol authoring and review of regulatory documents. Working knowledge of technological platforms covering biomarker measures including but not limited to genomics, gene expression, immune profiling, and flow cytometry. Excellent data analysis and problem-solving skills Exceptional verbal and written communication skills with experience in developing written documents such as primary manuscripts/publications/reviews, scientific presentations and regulatory submissions (INDs/NDAs) with ability to synthesize complex scientific concepts into simple communication points Proven scientific/project leadership expertise and experience working in global teams and managing people/projects Responsibilities: Integrate translational research and clinical development, developing biomarker strategies in alignment with clinical development objectives, leading efforts for data generation and interpretation and for communication to the development teams. Responsible for understanding external research environment, partnering with other functions both internally and externally to coordinate the execution of Translational development deliverables. Engages functional groups to develop, champion, implement and align biomarker strategies for development projects in support of the overall R&D portfolio goals. Effectively engages with teams and matrix leadership to define, revise and progress translational biomarker plans. Continually analyzes progress, engages in critical thinking, and asserts strong problem-solving towards delivering key data and interpretations essential for decision making. Delivers high quality biomarker strategies for understanding mechanism of action/resistance, target engagement, pharmacodynamics endpoints and patient selection. Ensures the output of the biomarker plans meets established project standards. Engages team members to ensure alignment of biomarker strategies with clinical operational plans and with functional area capabilities to execute and deliver on robust translational biomarker data package to support trial and program Builds productive relationships with team members that interact with the translational clinical biomarker group. Effectively interfaces with functional areas to ensure strategic alignment and to identify resources needed to deliver on biomarker goals. Communicates key biomarker program information, risks, and milestones, and manages information flow across team members Qualifications: Ph.D. in Oncology/immunology or related field with 5-8+ years of industry experience 3-5 years in oncology/biomarkers/translational or corcriptive research Bristol Myers Squibb is an equal employment opportunity employer and welcomes applications from diverse candidates.
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Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. 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. Bristol Myers Squibb has pioneered the development of immuno-oncology therapies and continues to diversify in drug development for the treatment of cancers. Our world-class Translational Development organization is exploring new aspects of tumor and immune biology to create tailored, individualized treatment strategies that will offer the greatest possible benefit to patients. The Clinical Biomarker Lead role will be responsible for development and execution of translational strategies in solid tumor oncology for assigned programs. Key responsibilities of this role are to act as a lead scientist to implement and deliver on biomarker strategies for clinical programs, develop reports and publications on translational data generated to support asset development and contribute to regulatory submissions. Professional Skills In-depth understanding of solid tumor oncology with knowledge of current and evolving clinical landscape and competitive scenarios Strong scientific background with understanding of clinical, translational, and mechanistic data with proven track record of publications Understanding of early or late-stage drug and translational development process; including experience with implementing a biomarker strategy Clinical protocol authoring and review of regulatory documents. Working knowledge of technological platforms covering biomarker measures including but not limited to genomics, gene expression, immune profiling, and flow cytometry. Excellent data analysis and problem-solving skills Exceptional verbal and written communication skills with experience in developing written documents such as primary manuscripts/publications/reviews, scientific presentations and regulatory submissions (INDs/NDAs) with ability to synthesize complex scientific concepts into simple communication points Proven scientific/project leadership expertise and experience working in global teams and managing people/projects Responsibilities: Integrate translational research and clinical development, developing biomarker strategies in alignment with clinical development objectives, leading efforts for data generation and interpretation and for communication to the development teams. Responsible for understanding external research environment, partnering with other functions both internally and externally to coordinate the execution of Translational development deliverables. Engages functional groups to develop, champion, implement and align biomarker strategies for development projects in support of the overall R&D portfolio goals. Effectively engages with teams and matrix leadership to define, revise and progress translational biomarker plans. Continually analyzes progress, engages in critical thinking, and asserts strong problem-solving towards delivering key data and interpretations essential for decision making. Delivers high quality biomarker strategies for understanding mechanism of action/resistance, target engagement, pharmacodynamics endpoints and patient selection. Ensures the output of the biomarker plans meets established project standards. Engages team members to ensure alignment of biomarker strategies with clinical operational plans and with functional area capabilities to execute and deliver on robust translational biomarker data package to support trial and program Builds productive relationships with team members that interact with the translational clinical biomarker group. Effectively interfaces with functional areas to ensure strategic alignment and to identify resources needed to deliver on biomarker goals. Communicates key biomarker program information, risks, and milestones, and manages information flow across team members Qualifications: Ph.D. in Oncology/immunology or related field with 5-8+ years of industry experience 3-5 years in oncology/biomarkers/translational or corcriptive research Bristol Myers Squibb is an equal employment opportunity employer and welcomes applications from diverse candidates.
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