Bristol-Myers Squibb
Director, Early Clinical Development (MD) - Oncology
Bristol-Myers Squibb, Princeton, New Jersey, us, 08543
Director, Early Clinical Development (MD) - OncologyWorking with UsChallenging. 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. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
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.
The Early Clinical Development function is part of a global scientific organization dedicated to initial evaluations of new molecules, biomarkers, and mechanistic hypotheses in humans. The group drives early clinical strategy, and the design, execution, and interpretation of studies to select the most promising drug candidates for later development.
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 byArticulating 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 early development clinical 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 oversees contributions 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 (input on inclusion/exclusion and other safety-related clinical 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 early development clinical 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; clinical 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 working with Clinical Scientists
Partners with Clinical Scientists 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 Clinical Scientists 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
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 development projects
Authors/drafts clinical content for CSRs, regulatory reports, briefing books and submission documents to support closure, clinical narratives, reporting and filling of the study in partnership with Clinical Scientists
External Partnerships, Alliances, and Publications
Sits in team responsible for establishing key alliances with academic centers, co-operative groups, vendors and government agencies
Represents department in business development due diligence and partner alliance management with oversight
Acts as a focal point for defining and establishing relationships with key global Phase 1 Centers
Track record or recognized for contributions to field (e.g., publications, patents, keynote participation in conferences etc.)
Degree Requirements
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 applicable therapeutic area preferred
Experience Requirements
5+ years of relevant experience in discovery, translational and/or clinical research in academic or industry setting including education where applicable
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 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
The starting compensation for this job is a range from $279,000-321,000, plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience.
Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as “Transforming patients’ lives through science”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer.
#J-18808-Ljbffr
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.
The Early Clinical Development function is part of a global scientific organization dedicated to initial evaluations of new molecules, biomarkers, and mechanistic hypotheses in humans. The group drives early clinical strategy, and the design, execution, and interpretation of studies to select the most promising drug candidates for later development.
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 byArticulating 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 early development clinical 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 oversees contributions 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 (input on inclusion/exclusion and other safety-related clinical 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 early development clinical 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; clinical 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 working with Clinical Scientists
Partners with Clinical Scientists 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 Clinical Scientists 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
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 development projects
Authors/drafts clinical content for CSRs, regulatory reports, briefing books and submission documents to support closure, clinical narratives, reporting and filling of the study in partnership with Clinical Scientists
External Partnerships, Alliances, and Publications
Sits in team responsible for establishing key alliances with academic centers, co-operative groups, vendors and government agencies
Represents department in business development due diligence and partner alliance management with oversight
Acts as a focal point for defining and establishing relationships with key global Phase 1 Centers
Track record or recognized for contributions to field (e.g., publications, patents, keynote participation in conferences etc.)
Degree Requirements
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 applicable therapeutic area preferred
Experience Requirements
5+ years of relevant experience in discovery, translational and/or clinical research in academic or industry setting including education where applicable
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 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
The starting compensation for this job is a range from $279,000-321,000, plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience.
Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as “Transforming patients’ lives through science”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer.
#J-18808-Ljbffr