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Bristol-Myers Squibb logo

Director, Early Clinical Development (MD) – Hematology & Cell Therapy

Bristol-Myers Squibb

Director, Early Clinical Development (MD) – Hematology & Cell Therapy

Bristol-Myers Squibb logo

Bristol-Myers Squibb

full-time

Posted: November 20, 2025

Number of Vacancies: 1

Job Description

The Early Clinical Development - HOCT function is part of a global organization dedicated to the effective design and execution of early drug development. Early Clinical Development drives clinical development strategy, design, execution, and interpretation of clinical trials. Manages Phase I/II studies, with demonstrated decision making capabilities Provides medical and scientific expertise to cross-functional BMS colleagues Medical Monitoring Independent medical monitor for clinical trials from Phase 1 through Proof-of-Concept by Articulating clinical development strategy Analyzing, interpreting, and acting on Clinical Trial data to support development, and Serving as principal functional author for Regulatory submission, study reports, and publications Provides oversight and medical accountability for multiple trials across early development clinical lifecycle Manages site interactions in partnership with the Clinical Scientist (CS) for medical questions and education (including safety management guidelines) Assesses key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversees safety narratives Contributes to and is a key member of a high performing Study Delivery Team (SDT) and may be a member of the Development Team Collaborates with CS and provides input into protocols, contributing medical strategic oversight in protocol development (input on inclusion/exclusion and other safety-related clinical considerations) Fulfills GCP and compliance obligations for clinical conduct and maintains all required training Works on multiple trials across early development clinical lifecycle. Contributes to key Health Authority interactions and advisory board meetings as Early Clinical Development Physician; serves as Primary Clinical Representative in Regulatory interactions for early development projects 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. Designs and develops clinical studies and research plans in support of asset strategy with the Early Clinical Development Leadership team; Clinical studies include first-in-human Phase I, proof of concept Phase I/II, entry registrational studies, and/or clinical pharmacology studies Liaises with Clinical Scientists, Translational & Discovery Scientists and Development Teams to define dose and schedule, indications, and patient selection (e.g., biomarker qualification and implementation) Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment working with Clinical Scientists Partners with CS to support executional delivery of studies (e.g., site activation, enrollment status, as well as adjudication for protocol violations, significant, non-significant deviations etc.) Maintains a strong medical/scientific reputation within the disease area; has in-depth knowledge of etiology, natural history, diagnosis, and treatment of the disorder Keeps up to date in the disease area by attending scientific conferences and ongoing review of the literature Keeps abreast of development and regulatory issues related to other competitive or relevant compounds in development and how our portfolio fits into the competitive landscape Provides ongoing medical education in partnership with CS to allow for protocol-specific training, supporting the study team, investigators, and others Ad-Hoc involvement in various departmental initiatives (e.g., committees, sub-teams etc.) Presents and/or articulates clinical strategy to senior leadership and to support progression of portfolio Advanced degree(s) in relevant field: MD, MD/PhD (or x-US equivalent) and clinical expertise in a therapeutic area (e.g., attending level or international equivalent) Subspecialty fellowship training in rheumatology or hematology area preferred 5+ years of relevant experience in discovery, translational and/or clinical research in academic or industry setting including education where applicable Clinical trial leadership experience (e.g., study director, etc.) within pharmaceutical industry preferred OR Significant independent clinical/laboratory/translational research experience in academic/pharmaceutical setting preferred including demonstrable achievement in experimental design, interpretation and exposition Ability to communicate and present information clearly in scientific and clinical settings Expertise in the scientific method to test hypotheses, including statistical design, analysis, and interpretation Knowledge of drug development process Knowledge of the components needed to execute an effective clinical plan and protocols Strong leadership skills with proven ability to lead and work effectively in a team environment

About the Role/Company

  • The Early Clinical Development - HOCT function is part of a global organization dedicated to the effective design and execution of early drug development

Key Responsibilities

  • Drive clinical development strategy, design, execution, and interpretation of clinical trials
  • Manage Phase I/II studies, with demonstrated decision making capabilities
  • Provide medical and scientific expertise to cross-functional BMS colleagues
  • Serve as independent medical monitor for clinical trials from Phase 1 through Proof-of-Concept
  • Articulate clinical development strategy
  • Analyze, interpret, and act on Clinical Trial data to support development
  • Serve as principal functional author for Regulatory submission, study reports, and publications
  • Provide oversight and medical accountability for multiple trials across early development clinical lifecycle
  • Manage site interactions in partnership with the Clinical Scientist (CS) for medical questions and education
  • Assess key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversee safety narratives
  • Contribute to and be a key member of a high performing Study Delivery Team (SDT) and may be a member of the Development Team
  • Collaborate with CS and provide input into protocols, contributing medical strategic oversight in protocol development
  • Fulfill GCP and compliance obligations for clinical conduct and maintain all required training
  • Contribute to key Health Authority interactions and advisory board meetings as Early Clinical Development Physician
  • Serve as Primary Clinical Representative in Regulatory interactions for early development projects
  • Design and develop clinical studies and research plans in support of asset strategy with the Early Clinical Development Leadership team
  • Liaise with Clinical Scientists, Translational & Discovery Scientists and Development Teams to define dose and schedule, indications, and patient selection
  • Lead the analysis of benefit/risk for clinical development protocols in a matrix team environment
  • Partner with CS to support executional delivery of studies
  • Maintain a strong medical/scientific reputation within the disease area
  • Keep up to date in the disease area by attending scientific conferences and ongoing review of the literature
  • Keep abreast of development and regulatory issues related to other competitive or relevant compounds
  • Provide ongoing medical education in partnership with CS
  • Participate in ad-hoc departmental initiatives
  • Present and articulate clinical strategy to senior leadership to support progression of portfolio

Required Qualifications

  • Advanced degree(s) in relevant field: MD, MD/PhD (or x-US equivalent)
  • Clinical expertise in a therapeutic area (e.g., attending level or international equivalent)

Preferred Qualifications

  • Subspecialty fellowship training in rheumatology or hematology area
  • + years of relevant experience in discovery, translational and/or clinical research in academic or industry setting
  • Clinical trial leadership experience (e.g., study director, etc.) within pharmaceutical industry
  • Significant independent clinical/laboratory/translational research experience in academic/pharmaceutical setting
  • Demonstrable achievement in experimental design, interpretation and exposition

Skills Required

  • Ability to communicate and present information clearly in scientific and clinical settings
  • Expertise in the scientific method to test hypotheses, including statistical design, analysis, and interpretation
  • Knowledge of drug development process
  • Knowledge of the components needed to execute an effective clinical plan and protocols
  • Strong leadership skills with proven ability to lead and work effectively in a team environment

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

  • Brisbane CA, United States
  • Cambridge Crossing MA, United States
  • Princeton NJ, United States
  • Madison Giralda NJ, United States

Salary

Salary not disclosed

Estimated Salary Rangemedium confidence

300,000 - 450,000 USD / yearly

Source: ai estimated

* This is an estimated range based on market data and may vary based on experience and qualifications.

Skills Required

  • Ability to communicate and present information clearly in scientific and clinical settingsintermediate
  • Expertise in the scientific method to test hypotheses, including statistical design, analysis, and interpretationintermediate
  • Knowledge of drug development processintermediate
  • Knowledge of the components needed to execute an effective clinical plan and protocolsintermediate
  • Strong leadership skills with proven ability to lead and work effectively in a team environmentintermediate

Required Qualifications

  • Advanced degree(s) in relevant field: MD, MD/PhD (or x-US equivalent) (experience)
  • Clinical expertise in a therapeutic area (e.g., attending level or international equivalent) (experience)

Preferred Qualifications

  • Subspecialty fellowship training in rheumatology or hematology area (experience)
  • + years of relevant experience in discovery, translational and/or clinical research in academic or industry setting (experience)
  • Clinical trial leadership experience (e.g., study director, etc.) within pharmaceutical industry (experience)
  • Significant independent clinical/laboratory/translational research experience in academic/pharmaceutical setting (experience)
  • Demonstrable achievement in experimental design, interpretation and exposition (experience)

Responsibilities

  • Drive clinical development strategy, design, execution, and interpretation of clinical trials
  • Manage Phase I/II studies, with demonstrated decision making capabilities
  • Provide medical and scientific expertise to cross-functional BMS colleagues
  • Serve as independent medical monitor for clinical trials from Phase 1 through Proof-of-Concept
  • Articulate clinical development strategy
  • Analyze, interpret, and act on Clinical Trial data to support development
  • Serve as principal functional author for Regulatory submission, study reports, and publications
  • Provide oversight and medical accountability for multiple trials across early development clinical lifecycle
  • Manage site interactions in partnership with the Clinical Scientist (CS) for medical questions and education
  • Assess key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversee safety narratives
  • Contribute to and be a key member of a high performing Study Delivery Team (SDT) and may be a member of the Development Team
  • Collaborate with CS and provide input into protocols, contributing medical strategic oversight in protocol development
  • Fulfill GCP and compliance obligations for clinical conduct and maintain all required training
  • Contribute to key Health Authority interactions and advisory board meetings as Early Clinical Development Physician
  • Serve as Primary Clinical Representative in Regulatory interactions for early development projects
  • Design and develop clinical studies and research plans in support of asset strategy with the Early Clinical Development Leadership team
  • Liaise with Clinical Scientists, Translational & Discovery Scientists and Development Teams to define dose and schedule, indications, and patient selection
  • Lead the analysis of benefit/risk for clinical development protocols in a matrix team environment
  • Partner with CS to support executional delivery of studies
  • Maintain a strong medical/scientific reputation within the disease area
  • Keep up to date in the disease area by attending scientific conferences and ongoing review of the literature
  • Keep abreast of development and regulatory issues related to other competitive or relevant compounds
  • Provide ongoing medical education in partnership with CS
  • Participate in ad-hoc departmental initiatives
  • Present and articulate clinical strategy to senior leadership to support progression of portfolio

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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Bristol-Myers Squibb logo

Director, Early Clinical Development (MD) – Hematology & Cell Therapy

Bristol-Myers Squibb

Director, Early Clinical Development (MD) – Hematology & Cell Therapy

Bristol-Myers Squibb logo

Bristol-Myers Squibb

full-time

Posted: November 20, 2025

Number of Vacancies: 1

Job Description

The Early Clinical Development - HOCT function is part of a global organization dedicated to the effective design and execution of early drug development. Early Clinical Development drives clinical development strategy, design, execution, and interpretation of clinical trials. Manages Phase I/II studies, with demonstrated decision making capabilities Provides medical and scientific expertise to cross-functional BMS colleagues Medical Monitoring Independent medical monitor for clinical trials from Phase 1 through Proof-of-Concept by Articulating clinical development strategy Analyzing, interpreting, and acting on Clinical Trial data to support development, and Serving as principal functional author for Regulatory submission, study reports, and publications Provides oversight and medical accountability for multiple trials across early development clinical lifecycle Manages site interactions in partnership with the Clinical Scientist (CS) for medical questions and education (including safety management guidelines) Assesses key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversees safety narratives Contributes to and is a key member of a high performing Study Delivery Team (SDT) and may be a member of the Development Team Collaborates with CS and provides input into protocols, contributing medical strategic oversight in protocol development (input on inclusion/exclusion and other safety-related clinical considerations) Fulfills GCP and compliance obligations for clinical conduct and maintains all required training Works on multiple trials across early development clinical lifecycle. Contributes to key Health Authority interactions and advisory board meetings as Early Clinical Development Physician; serves as Primary Clinical Representative in Regulatory interactions for early development projects 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. Designs and develops clinical studies and research plans in support of asset strategy with the Early Clinical Development Leadership team; Clinical studies include first-in-human Phase I, proof of concept Phase I/II, entry registrational studies, and/or clinical pharmacology studies Liaises with Clinical Scientists, Translational & Discovery Scientists and Development Teams to define dose and schedule, indications, and patient selection (e.g., biomarker qualification and implementation) Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment working with Clinical Scientists Partners with CS to support executional delivery of studies (e.g., site activation, enrollment status, as well as adjudication for protocol violations, significant, non-significant deviations etc.) Maintains a strong medical/scientific reputation within the disease area; has in-depth knowledge of etiology, natural history, diagnosis, and treatment of the disorder Keeps up to date in the disease area by attending scientific conferences and ongoing review of the literature Keeps abreast of development and regulatory issues related to other competitive or relevant compounds in development and how our portfolio fits into the competitive landscape Provides ongoing medical education in partnership with CS to allow for protocol-specific training, supporting the study team, investigators, and others Ad-Hoc involvement in various departmental initiatives (e.g., committees, sub-teams etc.) Presents and/or articulates clinical strategy to senior leadership and to support progression of portfolio Advanced degree(s) in relevant field: MD, MD/PhD (or x-US equivalent) and clinical expertise in a therapeutic area (e.g., attending level or international equivalent) Subspecialty fellowship training in rheumatology or hematology area preferred 5+ years of relevant experience in discovery, translational and/or clinical research in academic or industry setting including education where applicable Clinical trial leadership experience (e.g., study director, etc.) within pharmaceutical industry preferred OR Significant independent clinical/laboratory/translational research experience in academic/pharmaceutical setting preferred including demonstrable achievement in experimental design, interpretation and exposition Ability to communicate and present information clearly in scientific and clinical settings Expertise in the scientific method to test hypotheses, including statistical design, analysis, and interpretation Knowledge of drug development process Knowledge of the components needed to execute an effective clinical plan and protocols Strong leadership skills with proven ability to lead and work effectively in a team environment

About the Role/Company

  • The Early Clinical Development - HOCT function is part of a global organization dedicated to the effective design and execution of early drug development

Key Responsibilities

  • Drive clinical development strategy, design, execution, and interpretation of clinical trials
  • Manage Phase I/II studies, with demonstrated decision making capabilities
  • Provide medical and scientific expertise to cross-functional BMS colleagues
  • Serve as independent medical monitor for clinical trials from Phase 1 through Proof-of-Concept
  • Articulate clinical development strategy
  • Analyze, interpret, and act on Clinical Trial data to support development
  • Serve as principal functional author for Regulatory submission, study reports, and publications
  • Provide oversight and medical accountability for multiple trials across early development clinical lifecycle
  • Manage site interactions in partnership with the Clinical Scientist (CS) for medical questions and education
  • Assess key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversee safety narratives
  • Contribute to and be a key member of a high performing Study Delivery Team (SDT) and may be a member of the Development Team
  • Collaborate with CS and provide input into protocols, contributing medical strategic oversight in protocol development
  • Fulfill GCP and compliance obligations for clinical conduct and maintain all required training
  • Contribute to key Health Authority interactions and advisory board meetings as Early Clinical Development Physician
  • Serve as Primary Clinical Representative in Regulatory interactions for early development projects
  • Design and develop clinical studies and research plans in support of asset strategy with the Early Clinical Development Leadership team
  • Liaise with Clinical Scientists, Translational & Discovery Scientists and Development Teams to define dose and schedule, indications, and patient selection
  • Lead the analysis of benefit/risk for clinical development protocols in a matrix team environment
  • Partner with CS to support executional delivery of studies
  • Maintain a strong medical/scientific reputation within the disease area
  • Keep up to date in the disease area by attending scientific conferences and ongoing review of the literature
  • Keep abreast of development and regulatory issues related to other competitive or relevant compounds
  • Provide ongoing medical education in partnership with CS
  • Participate in ad-hoc departmental initiatives
  • Present and articulate clinical strategy to senior leadership to support progression of portfolio

Required Qualifications

  • Advanced degree(s) in relevant field: MD, MD/PhD (or x-US equivalent)
  • Clinical expertise in a therapeutic area (e.g., attending level or international equivalent)

Preferred Qualifications

  • Subspecialty fellowship training in rheumatology or hematology area
  • + years of relevant experience in discovery, translational and/or clinical research in academic or industry setting
  • Clinical trial leadership experience (e.g., study director, etc.) within pharmaceutical industry
  • Significant independent clinical/laboratory/translational research experience in academic/pharmaceutical setting
  • Demonstrable achievement in experimental design, interpretation and exposition

Skills Required

  • Ability to communicate and present information clearly in scientific and clinical settings
  • Expertise in the scientific method to test hypotheses, including statistical design, analysis, and interpretation
  • Knowledge of drug development process
  • Knowledge of the components needed to execute an effective clinical plan and protocols
  • Strong leadership skills with proven ability to lead and work effectively in a team environment

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

  • Brisbane CA, United States
  • Cambridge Crossing MA, United States
  • Princeton NJ, United States
  • Madison Giralda NJ, United States

Salary

Salary not disclosed

Estimated Salary Rangemedium confidence

300,000 - 450,000 USD / yearly

Source: ai estimated

* This is an estimated range based on market data and may vary based on experience and qualifications.

Skills Required

  • Ability to communicate and present information clearly in scientific and clinical settingsintermediate
  • Expertise in the scientific method to test hypotheses, including statistical design, analysis, and interpretationintermediate
  • Knowledge of drug development processintermediate
  • Knowledge of the components needed to execute an effective clinical plan and protocolsintermediate
  • Strong leadership skills with proven ability to lead and work effectively in a team environmentintermediate

Required Qualifications

  • Advanced degree(s) in relevant field: MD, MD/PhD (or x-US equivalent) (experience)
  • Clinical expertise in a therapeutic area (e.g., attending level or international equivalent) (experience)

Preferred Qualifications

  • Subspecialty fellowship training in rheumatology or hematology area (experience)
  • + years of relevant experience in discovery, translational and/or clinical research in academic or industry setting (experience)
  • Clinical trial leadership experience (e.g., study director, etc.) within pharmaceutical industry (experience)
  • Significant independent clinical/laboratory/translational research experience in academic/pharmaceutical setting (experience)
  • Demonstrable achievement in experimental design, interpretation and exposition (experience)

Responsibilities

  • Drive clinical development strategy, design, execution, and interpretation of clinical trials
  • Manage Phase I/II studies, with demonstrated decision making capabilities
  • Provide medical and scientific expertise to cross-functional BMS colleagues
  • Serve as independent medical monitor for clinical trials from Phase 1 through Proof-of-Concept
  • Articulate clinical development strategy
  • Analyze, interpret, and act on Clinical Trial data to support development
  • Serve as principal functional author for Regulatory submission, study reports, and publications
  • Provide oversight and medical accountability for multiple trials across early development clinical lifecycle
  • Manage site interactions in partnership with the Clinical Scientist (CS) for medical questions and education
  • Assess key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversee safety narratives
  • Contribute to and be a key member of a high performing Study Delivery Team (SDT) and may be a member of the Development Team
  • Collaborate with CS and provide input into protocols, contributing medical strategic oversight in protocol development
  • Fulfill GCP and compliance obligations for clinical conduct and maintain all required training
  • Contribute to key Health Authority interactions and advisory board meetings as Early Clinical Development Physician
  • Serve as Primary Clinical Representative in Regulatory interactions for early development projects
  • Design and develop clinical studies and research plans in support of asset strategy with the Early Clinical Development Leadership team
  • Liaise with Clinical Scientists, Translational & Discovery Scientists and Development Teams to define dose and schedule, indications, and patient selection
  • Lead the analysis of benefit/risk for clinical development protocols in a matrix team environment
  • Partner with CS to support executional delivery of studies
  • Maintain a strong medical/scientific reputation within the disease area
  • Keep up to date in the disease area by attending scientific conferences and ongoing review of the literature
  • Keep abreast of development and regulatory issues related to other competitive or relevant compounds
  • Provide ongoing medical education in partnership with CS
  • Participate in ad-hoc departmental initiatives
  • Present and articulate clinical strategy to senior leadership to support progression of portfolio

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

Target Your Resume for "Director, Early Clinical Development (MD) – Hematology & Cell Therapy" , Bristol-Myers Squibb

Get personalized recommendations to optimize your resume specifically for Director, Early Clinical Development (MD) – Hematology & Cell Therapy. Takes only 15 seconds!

AI-powered keyword optimization
Skills matching & gap analysis
Experience alignment suggestions

Check Your ATS Score for "Director, Early Clinical Development (MD) – Hematology & Cell Therapy" , Bristol-Myers Squibb

Find out how well your resume matches this job's requirements. Get comprehensive analysis including ATS compatibility, keyword matching, skill gaps, and personalized recommendations.

ATS compatibility check
Keyword optimization analysis
Skill matching & gap identification
Format & readability score

Tags & Categories

PharmaceuticalPharmaceuticalHealthcare

Related Jobs You May Like

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