Oncology Clinical Biomarker Lead, Translational Development
Bristol-Myers Squibb
Oncology Clinical Biomarker Lead, Translational Development
Job Description
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 Ph.D. in Oncology/immunology or related field with 5-8+ years of industry experience 3-5 years in oncology/biomarkers/translational or correlative research Requires comprehensive knowledge of principles, concepts and / or methodologies within drug discovery or clinical development Has significant understanding of the role of translational research/medicine and clinical biomarkers in drug development Demonstrated knowledge of oncology and/or tumor-immunology disease biology Preferably has strong understanding of immuno-angiogenic therapies 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 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.
Key Responsibilities
- Integrate translational research and clinical development
- Develop biomarker strategies in alignment with clinical development objectives
- Lead efforts for data generation and interpretation
- Communicate data and interpretations to development teams
- Understand external research environment
- Partner with other functions internally and externally to coordinate execution of Translational development deliverables
- Engage functional groups to develop, champion, implement, and align biomarker strategies for development projects
- Support overall R&D portfolio goals
- Engage with teams and matrix leadership to define, revise, and progress translational biomarker plans
- Analyze progress and engage in critical thinking
- Assert strong problem-solving towards delivering key data and interpretations essential for decision making
- Deliver high quality biomarker strategies for understanding mechanism of action/resistance, target engagement, pharmacodynamics endpoints, and patient selection
- Ensure output of biomarker plans meets established project standards
- Engage team members to ensure alignment of biomarker strategies with clinical operational plans and functional area capabilities
- Deliver robust translational biomarker data package to support trial and program
- Build productive relationships with team members interacting with the translational clinical biomarker group
- Interface with functional areas to ensure strategic alignment and identify resources needed to deliver on biomarker goals
- Communicate key biomarker program information, risks, and milestones
- Manage information flow across team members
Required Qualifications
- Ph.D. in Oncology/Immunology or related field
- -8+ years of industry experience
- -5 years in oncology/biomarkers/translational or correlative research
- Comprehensive knowledge of principles, concepts, and methodologies within drug discovery or clinical development
- Significant understanding of the role of translational research/medicine and clinical biomarkers in drug development
- Demonstrated knowledge of oncology and/or tumor-immunology disease biology
Preferred Qualifications
- Strong understanding of immuno-angiogenic therapies
Skills Required
- In-depth understanding of solid tumor oncology
- Knowledge of current and evolving clinical landscape and competitive scenarios
- Strong scientific background with understanding of clinical, translational, and mechanistic data
- Proven track record of publications
- Understanding of early or late-stage drug and translational development process
- Experience with implementing a biomarker strategy
- Clinical protocol authoring and review of regulatory documents
- Working knowledge of technological platforms covering biomarker measures including genomics, gene expression, immune profiling, and flow cytometry
- Excellent data analysis and problem-solving skills
- Exceptional verbal and written communication skills
- Experience in developing written documents such as primary manuscripts/publications/reviews, scientific presentations, and regulatory submissions (INDs/NDAs)
- Ability to synthesize complex scientific concepts into simple communication points
- Proven scientific/project leadership expertise
- Experience working in global teams and managing people/projects
Benefits & Perks
- 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
- Summer hours flexibility
Locations
- Princeton NJ, United States
Salary
Estimated Salary Rangemedium confidence
150,000 - 250,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- In-depth understanding of solid tumor oncologyintermediate
- Knowledge of current and evolving clinical landscape and competitive scenariosintermediate
- Strong scientific background with understanding of clinical, translational, and mechanistic dataintermediate
- Proven track record of publicationsintermediate
- Understanding of early or late-stage drug and translational development processintermediate
- Experience with implementing a biomarker strategyintermediate
- Clinical protocol authoring and review of regulatory documentsintermediate
- Working knowledge of technological platforms covering biomarker measures including genomics, gene expression, immune profiling, and flow cytometryintermediate
- Excellent data analysis and problem-solving skillsintermediate
- Exceptional verbal and written communication skillsintermediate
- Experience in developing written documents such as primary manuscripts/publications/reviews, scientific presentations, and regulatory submissions (INDs/NDAs)intermediate
- Ability to synthesize complex scientific concepts into simple communication pointsintermediate
- Proven scientific/project leadership expertiseintermediate
- Experience working in global teams and managing people/projectsintermediate
Required Qualifications
- Ph.D. in Oncology/Immunology or related field (experience)
- -8+ years of industry experience (experience)
- -5 years in oncology/biomarkers/translational or correlative research (experience)
- Comprehensive knowledge of principles, concepts, and methodologies within drug discovery or clinical development (experience)
- Significant understanding of the role of translational research/medicine and clinical biomarkers in drug development (experience)
- Demonstrated knowledge of oncology and/or tumor-immunology disease biology (experience)
Preferred Qualifications
- Strong understanding of immuno-angiogenic therapies (experience)
Responsibilities
- Integrate translational research and clinical development
- Develop biomarker strategies in alignment with clinical development objectives
- Lead efforts for data generation and interpretation
- Communicate data and interpretations to development teams
- Understand external research environment
- Partner with other functions internally and externally to coordinate execution of Translational development deliverables
- Engage functional groups to develop, champion, implement, and align biomarker strategies for development projects
- Support overall R&D portfolio goals
- Engage with teams and matrix leadership to define, revise, and progress translational biomarker plans
- Analyze progress and engage in critical thinking
- Assert strong problem-solving towards delivering key data and interpretations essential for decision making
- Deliver high quality biomarker strategies for understanding mechanism of action/resistance, target engagement, pharmacodynamics endpoints, and patient selection
- Ensure output of biomarker plans meets established project standards
- Engage team members to ensure alignment of biomarker strategies with clinical operational plans and functional area capabilities
- Deliver robust translational biomarker data package to support trial and program
- Build productive relationships with team members interacting with the translational clinical biomarker group
- Interface with functional areas to ensure strategic alignment and identify resources needed to deliver on biomarker goals
- Communicate key biomarker program information, risks, and milestones
- Manage information flow across team members
Benefits
- general: Paid national holidays and optional holidays
- general: Global Shutdown Days between Christmas and New Year's holiday
- general: Up to 120 hours of paid vacation
- general: Up to two (2) paid days to volunteer
- general: Sick time off
- general: Summer hours flexibility
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Oncology Clinical Biomarker Lead, Translational Development
Bristol-Myers Squibb
Oncology Clinical Biomarker Lead, Translational Development
Job Description
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 Ph.D. in Oncology/immunology or related field with 5-8+ years of industry experience 3-5 years in oncology/biomarkers/translational or correlative research Requires comprehensive knowledge of principles, concepts and / or methodologies within drug discovery or clinical development Has significant understanding of the role of translational research/medicine and clinical biomarkers in drug development Demonstrated knowledge of oncology and/or tumor-immunology disease biology Preferably has strong understanding of immuno-angiogenic therapies 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 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.
Key Responsibilities
- Integrate translational research and clinical development
- Develop biomarker strategies in alignment with clinical development objectives
- Lead efforts for data generation and interpretation
- Communicate data and interpretations to development teams
- Understand external research environment
- Partner with other functions internally and externally to coordinate execution of Translational development deliverables
- Engage functional groups to develop, champion, implement, and align biomarker strategies for development projects
- Support overall R&D portfolio goals
- Engage with teams and matrix leadership to define, revise, and progress translational biomarker plans
- Analyze progress and engage in critical thinking
- Assert strong problem-solving towards delivering key data and interpretations essential for decision making
- Deliver high quality biomarker strategies for understanding mechanism of action/resistance, target engagement, pharmacodynamics endpoints, and patient selection
- Ensure output of biomarker plans meets established project standards
- Engage team members to ensure alignment of biomarker strategies with clinical operational plans and functional area capabilities
- Deliver robust translational biomarker data package to support trial and program
- Build productive relationships with team members interacting with the translational clinical biomarker group
- Interface with functional areas to ensure strategic alignment and identify resources needed to deliver on biomarker goals
- Communicate key biomarker program information, risks, and milestones
- Manage information flow across team members
Required Qualifications
- Ph.D. in Oncology/Immunology or related field
- -8+ years of industry experience
- -5 years in oncology/biomarkers/translational or correlative research
- Comprehensive knowledge of principles, concepts, and methodologies within drug discovery or clinical development
- Significant understanding of the role of translational research/medicine and clinical biomarkers in drug development
- Demonstrated knowledge of oncology and/or tumor-immunology disease biology
Preferred Qualifications
- Strong understanding of immuno-angiogenic therapies
Skills Required
- In-depth understanding of solid tumor oncology
- Knowledge of current and evolving clinical landscape and competitive scenarios
- Strong scientific background with understanding of clinical, translational, and mechanistic data
- Proven track record of publications
- Understanding of early or late-stage drug and translational development process
- Experience with implementing a biomarker strategy
- Clinical protocol authoring and review of regulatory documents
- Working knowledge of technological platforms covering biomarker measures including genomics, gene expression, immune profiling, and flow cytometry
- Excellent data analysis and problem-solving skills
- Exceptional verbal and written communication skills
- Experience in developing written documents such as primary manuscripts/publications/reviews, scientific presentations, and regulatory submissions (INDs/NDAs)
- Ability to synthesize complex scientific concepts into simple communication points
- Proven scientific/project leadership expertise
- Experience working in global teams and managing people/projects
Benefits & Perks
- 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
- Summer hours flexibility
Locations
- Princeton NJ, United States
Salary
Estimated Salary Rangemedium confidence
150,000 - 250,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- In-depth understanding of solid tumor oncologyintermediate
- Knowledge of current and evolving clinical landscape and competitive scenariosintermediate
- Strong scientific background with understanding of clinical, translational, and mechanistic dataintermediate
- Proven track record of publicationsintermediate
- Understanding of early or late-stage drug and translational development processintermediate
- Experience with implementing a biomarker strategyintermediate
- Clinical protocol authoring and review of regulatory documentsintermediate
- Working knowledge of technological platforms covering biomarker measures including genomics, gene expression, immune profiling, and flow cytometryintermediate
- Excellent data analysis and problem-solving skillsintermediate
- Exceptional verbal and written communication skillsintermediate
- Experience in developing written documents such as primary manuscripts/publications/reviews, scientific presentations, and regulatory submissions (INDs/NDAs)intermediate
- Ability to synthesize complex scientific concepts into simple communication pointsintermediate
- Proven scientific/project leadership expertiseintermediate
- Experience working in global teams and managing people/projectsintermediate
Required Qualifications
- Ph.D. in Oncology/Immunology or related field (experience)
- -8+ years of industry experience (experience)
- -5 years in oncology/biomarkers/translational or correlative research (experience)
- Comprehensive knowledge of principles, concepts, and methodologies within drug discovery or clinical development (experience)
- Significant understanding of the role of translational research/medicine and clinical biomarkers in drug development (experience)
- Demonstrated knowledge of oncology and/or tumor-immunology disease biology (experience)
Preferred Qualifications
- Strong understanding of immuno-angiogenic therapies (experience)
Responsibilities
- Integrate translational research and clinical development
- Develop biomarker strategies in alignment with clinical development objectives
- Lead efforts for data generation and interpretation
- Communicate data and interpretations to development teams
- Understand external research environment
- Partner with other functions internally and externally to coordinate execution of Translational development deliverables
- Engage functional groups to develop, champion, implement, and align biomarker strategies for development projects
- Support overall R&D portfolio goals
- Engage with teams and matrix leadership to define, revise, and progress translational biomarker plans
- Analyze progress and engage in critical thinking
- Assert strong problem-solving towards delivering key data and interpretations essential for decision making
- Deliver high quality biomarker strategies for understanding mechanism of action/resistance, target engagement, pharmacodynamics endpoints, and patient selection
- Ensure output of biomarker plans meets established project standards
- Engage team members to ensure alignment of biomarker strategies with clinical operational plans and functional area capabilities
- Deliver robust translational biomarker data package to support trial and program
- Build productive relationships with team members interacting with the translational clinical biomarker group
- Interface with functional areas to ensure strategic alignment and identify resources needed to deliver on biomarker goals
- Communicate key biomarker program information, risks, and milestones
- Manage information flow across team members
Benefits
- general: Paid national holidays and optional holidays
- general: Global Shutdown Days between Christmas and New Year's holiday
- general: Up to 120 hours of paid vacation
- general: Up to two (2) paid days to volunteer
- general: Sick time off
- general: Summer hours flexibility
Tags & Categories
Answer 10 quick questions to check your fit for Oncology Clinical Biomarker Lead, Translational Development @ Bristol-Myers Squibb.
10 Questions
~2 Minutes
Instant Score
Related Books and Jobs