Bristol Myers Squibb
Director, Early Clinical Development - Immunology (Rheumatology)
Bristol Myers Squibb, San Diego, California, United States, 92189
Position Summary / Objective
Serves as a primary source of medical accountability and oversight for multiple clinical trials. Manages Phase I/II studies with demonstrated decision making capabilities. Provides medical and scientific expertise to cross-functional BMS colleagues. Maintains matrix management responsibilities across internal and external networks.
Position Responsibilities Medical Monitoring
Serves as an 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
Serving as principal functional author for Regulatory submission, study reports, and publications
Provides oversight and medical accountability for multiple trials across the early development lifecycle
Manages site interactions in partnership with the Clinical Scientist for medical questions and education (including safety management guidelines)
Assesses key safety-related serious adverse events in partnership with Worldwide Patient Safety and contributes to 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 Clinical Scientists and provides input into protocols, contributing medical strategic oversight in protocol development (inclusion/exclusion and other safety-related considerations)
Fulfills GCP and compliance obligations for clinical conduct and maintains all required training
Acts as a focal point for defining and establishing relationships with key global Phase I Centers
Works on multiple trials across the early development lifecycle
Clinical Development Expertise & Strategy
Designs and develops clinical studies and research plans in support of asset strategy with the Early Clinical Development Leadership team; studies include first-in-human Phase I, proof of concept Phase I/II, entry registrational studies, biomarker qualification 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
Partners with Clinical Scientists to support executional delivery of studies (site activation, enrollment status, adjudication of protocol violations and deviations)
Maintains a strong medical/scientific reputation within the disease area; has in-depth knowledge of etiology, natural history, diagnosis, and treatment
Keeps up to date in the disease area by attending scientific conferences and ongoing literature review
Keeps abreast of development and regulatory issues related to other compounds and portfolio fit
Provides ongoing medical education with Clinical Scientists to support protocol-specific training for the study team and investigators
Ad-Hoc involvement in departmental initiatives (e.g., committees, sub-teams)
Presents clinical strategy to senior leadership to support portfolio progression
Health Authority Interactions
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 projects
Authors/drafts clinical content for CSRs, regulatory reports, briefing books, and submission documents to support closure and clinical narratives in partnership with Clinical Scientists
External Partnerships, Alliances, and Publications
Participates in establishing alliances with academic centers, cooperative groups, vendors, and government agencies
Represent department in business development due diligence and partner alliance management
Acts as a focal point for relationships with key global Phase 1 Centers
Track record or recognition for contributions to the field (e.g., publications, patents, keynote conference participation)
Degree Requirements
Advanced degree(s) in relevant field: MD, MD/PhD (or equivalent) with clinical expertise in a therapeutic area
Subspecialty fellowship training in applicable therapeutic area preferred
Experience Requirements
5+ years of relevant experience in discovery, translational and/or clinical research in academic or industry settings
Key Competency Requirements
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 components needed to execute an effective clinical plan and protocols
Strong leadership skills with ability to lead and work effectively in a team
Travel Required
Domestic and international travel may be required
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Compensation Overview The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit the
url text careeers.bms.com/life-at-bms/.
Benefit offerings are subject to plan terms and may include medical, dental, vision, wellbeing programs, 401(k), life and disability insurance, vacation, holidays, volunteer time, parental and other leave, and other perks.
Additional Information Uniquely Interesting Work, Life-changing Careers: With a vision to Transforming patients’ lives through science, every BMS employee contributes to work beyond ordinary. On-site protocol and accommodations are provided as needed. The company emphasizes vaccination and equal employment opportunity and may include location-specific information for California residents and other jurisdictions. All data processed in connection with role applications will be handled per applicable privacy policies.
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Position Responsibilities Medical Monitoring
Serves as an 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
Serving as principal functional author for Regulatory submission, study reports, and publications
Provides oversight and medical accountability for multiple trials across the early development lifecycle
Manages site interactions in partnership with the Clinical Scientist for medical questions and education (including safety management guidelines)
Assesses key safety-related serious adverse events in partnership with Worldwide Patient Safety and contributes to 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 Clinical Scientists and provides input into protocols, contributing medical strategic oversight in protocol development (inclusion/exclusion and other safety-related considerations)
Fulfills GCP and compliance obligations for clinical conduct and maintains all required training
Acts as a focal point for defining and establishing relationships with key global Phase I Centers
Works on multiple trials across the early development lifecycle
Clinical Development Expertise & Strategy
Designs and develops clinical studies and research plans in support of asset strategy with the Early Clinical Development Leadership team; studies include first-in-human Phase I, proof of concept Phase I/II, entry registrational studies, biomarker qualification 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
Partners with Clinical Scientists to support executional delivery of studies (site activation, enrollment status, adjudication of protocol violations and deviations)
Maintains a strong medical/scientific reputation within the disease area; has in-depth knowledge of etiology, natural history, diagnosis, and treatment
Keeps up to date in the disease area by attending scientific conferences and ongoing literature review
Keeps abreast of development and regulatory issues related to other compounds and portfolio fit
Provides ongoing medical education with Clinical Scientists to support protocol-specific training for the study team and investigators
Ad-Hoc involvement in departmental initiatives (e.g., committees, sub-teams)
Presents clinical strategy to senior leadership to support portfolio progression
Health Authority Interactions
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 projects
Authors/drafts clinical content for CSRs, regulatory reports, briefing books, and submission documents to support closure and clinical narratives in partnership with Clinical Scientists
External Partnerships, Alliances, and Publications
Participates in establishing alliances with academic centers, cooperative groups, vendors, and government agencies
Represent department in business development due diligence and partner alliance management
Acts as a focal point for relationships with key global Phase 1 Centers
Track record or recognition for contributions to the field (e.g., publications, patents, keynote conference participation)
Degree Requirements
Advanced degree(s) in relevant field: MD, MD/PhD (or equivalent) with clinical expertise in a therapeutic area
Subspecialty fellowship training in applicable therapeutic area preferred
Experience Requirements
5+ years of relevant experience in discovery, translational and/or clinical research in academic or industry settings
Key Competency Requirements
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 components needed to execute an effective clinical plan and protocols
Strong leadership skills with ability to lead and work effectively in a team
Travel Required
Domestic and international travel may be required
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Compensation Overview The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit the
url text careeers.bms.com/life-at-bms/.
Benefit offerings are subject to plan terms and may include medical, dental, vision, wellbeing programs, 401(k), life and disability insurance, vacation, holidays, volunteer time, parental and other leave, and other perks.
Additional Information Uniquely Interesting Work, Life-changing Careers: With a vision to Transforming patients’ lives through science, every BMS employee contributes to work beyond ordinary. On-site protocol and accommodations are provided as needed. The company emphasizes vaccination and equal employment opportunity and may include location-specific information for California residents and other jurisdictions. All data processed in connection with role applications will be handled per applicable privacy policies.
#J-18808-Ljbffr