Senior Clinical Trial Physician II, Cell Therapy
Working 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.
Read more:
careers.
bms.
com/working-with-us.
The Senior Clinical Trial Physician II- Cell Therapy is the primary source of medical accountability and oversight for multiple clinical trials or a single trial with significant complexity within the Cell Therapy Global Drug Development organization.
The incumbent will be accountable, alongside the Clinical Development Team Lead, for the development of differentiated and strategic CDPs from phase I expansion through to registrational execution.
They will be foundational in working with teams in Research, Early and Late Development to providing insights into biology, translational elements as well as overall benefit risk assessments.
This role includes support of across portfolio activities in line with Clinical Excellence, including Protocol Review Committee, support of Business Development activities and Quality and compliance leadership.
The Senior Clinical Trial Physician II sits within Clinical Development, which is a global organization dedicated to the effective design and execution of drug development.
Clinical Development drives clinical development strategy, design, execution, and interpretation of clinical trials.
The sCTP II - Cell Therapy will report directly to the Clinical Development Team Leader - Cell Therapy and will deputize as required as a core member of the Cell Therapy Global Program Team.
Position
Summary:
Serves as a primary source of medical accountability and oversight for multiple clinical trials or a single trial with significant complexity within the Cell Therapy Global Drug Development organization Supervises the development, monitoring, analysis, and interpretation of clinical trials and will supervise and have accountability for the clinical components of regulatory filings.
Will contribute to overall cell therapy disease strategy for specific tumor types while ensuring a franchise overall portfolio view.
Provides strategic insights into the clinical development plans Provides medical and scientific expertise to cross-functional BMS colleagues Matrix management responsibilities across the internal and external network Manages Phase 1 to Phase 3 clinical studies, with demonstrated decision-making capabilities This role will include above disease / indication strategy work (i.
e.
Disease / Indication Strategy teams) The role will be foundational in working with teams in Research, Early and Late Development teams to support GT4/5 and POC transitions, providing insights into biology, translational elements as well as overall benefit risk assessments The role includes support of across portfolio activities in line with Clinical Excellence, including e.
g.
Protocol Review Committee, support of Business Development activities and Quality and Compliance leadership Technical/Functional
Responsibilities:
Clinical Development Expertise & Strategy A Senior Clinical Trial Physician II is a tenured drug developer who can independently design and construct clinical development plans and protocols with a strong strategic focus based on knowledge of asset/drug, disease area and relevant science in order to meet regulatory and disease strategy targets.
Done in conjunction with Clinical Development Team Lead or as a delegate when CDTL is not assigned Extensive experience in Research and Development (late and/or early development) and across various Phases of study design (FIH, study start-up, study execution, DBL & close-out) Oversees trial(s) within asset class or multiple trials across assets (ie Immunotherapy, targeted therapy, mABs, ADCs, CAR T, etc) & across various diseases with in-depth clinical development expertise Respected for Disease Expertise (internal to BMS and within the medical community) Disease Lead- able to serve as internal consultant for respective disease(s) based on scientific knowledge and therapeutic expertise Provides oversight and medical accountability for a group of high-priority studies Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment working with Clinical Scientists (CS) 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.
) Existing strong relationships with principal investigators.
Identifies and cultivates thought leaders in order to gain their inputs on emerging science in drug and biomarker research, disease knowledge, and design of clinical development studies and programs Keeps abreast of development and regulatory issues related to other competitive or relevant compounds in development and how our portfolio fits into the competitive landscapeSenior CTP II should be able to anticipate impact of external data which may shift internal clinical strategy and proactively assess needs for internal program (ie amendments, need for ad hoc analyses & implications to execution of internal programs) Provides ongoing medical education in partnership with collaborating Clinical Scientists to allow for protocol-specific training, supporting the study team, investigators, and internal stakeholders (ie medical affairs, commercial, translational medicine, access, etc) Medical Monitoring Leader of high performing Study Delivery Team (SDT) and key member of the Clinical Development Team (CDT) Study-Leader with ability to own/drive study level strategic decisions Leads medical data review of trial data, including eligibility review Holds responsibility for site interactions in partnership with the Clinical Scientist (CS) for medical questions and education (including safety management guidelines) Holds responsibility for assessment of key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversees safety narratives Leads collaboration with CS and inputs into protocols, providing 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 Onboarding Lead - provides guidance and training to new CTP (not limited to data management; systems training), therapeutic training, innovative study design and sets example of high proficiency for the organization Health Authority Interactions & Publications Serves as medical point of expertise in key Health Authority interactions and advisory board meetings as Clinical Trial Physician Authors 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 CSs Experience with regulatory submission & development of clinical sections in regulatory documents for submission across several markets Ability to lead strategic framework for clinical sections of regulatory documents Exceptional clinical response strategist for queries (written & oral) Stakeholder Engagement and Communication Will work closely with colleagues in BMS IO CT TRC, CT Correlative Research Team, Research & Discovery, Early and Late Development, Regulatory, Medical, Commercial and other key functional areas on a global basis; additionally, should have an external focus and build relationships with thought leaders, physicians, and patient advocacy groups outside of BMS.
Be recognized internally and externally as an expert in the field.
Partner and interact with colleagues from Research and Early Development who design and implement first in human through proof-of-concept trials and will assure a seamless transition into late-stage development (Phase II-III trials.
) Ability to influence leadership and upper management of key functions (e.
g.
, early development, TM, clinical pharmacology, toxicology, regulatory, HEOR, market access, medical affairs), applying foresight, scientific and development knowledge to ensure support of late clinical development needs and adequacy of clinical studies leading to registration
Qualifications:
EXPERIENCE/TECHNICAL BACKGROUND AND KNOWLEDGE MD (or ex-US equivalent) The ideal candidate will be a Clinical Development leader; with greater than 5 years of extensive clinical trial and drug development experience and regulatory experience, in addition to a strong scientific background.
Deep understanding of Biology, targets and translational science.
Extensive experience of work with health authorities at all levels.
The candidate also must be a highly effective leader capable of working with Commercial, Medical, and all research functions of the company from Research through Regulatory.
The candidate must be comfortable with cross-functional drug and product development teams and managing in a matrix environment.
Global experiences since this position has responsibility for strategy and clinical research in oncology in multiple geographies.
Key Competency Requirements:
Ability to communicate information clearly and lead presentations in scientific and clinical settings Subspecialty training in applicable therapeutic area desired Expertise in the scientific method to test hypotheses, including statistical design, analysis, and interpretation Expertise in drug development process Expertise in 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 Ability to work independently & prioritize work (self-starter / takes initiative) Takes ownership and accountability Embodies collaborative-spirit, enterprise mindset & ability to see what's needed to be successful in the future Enterprise mindset with strong understanding of development priorities across programs, studies, expenses and cross-functional workstreams Travel required:
domestic and international travel may be required The starting compensation for this job is a range from $308,000-$354,000, 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 the where the job is performed.
Final individual compensation will be decided based on demonstrated experience.
For more on benefits, please visit our Working With Us (bms.
com)Eligibility for specific benefits listed on our BMS Careers site may vary based on the job and location.
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.
Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as Transforming patients' lives through science(TM) , 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.
On-site ProtocolPhysical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
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.
If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to email protected .
Visit careers.
bms.
com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities.
As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Recommended Skills Biology Business Development Clinical Research Clinical Works Consulting Data Management Estimated Salary: $20 to $28 per hour based on qualifications.
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.
Read more:
careers.
bms.
com/working-with-us.
The Senior Clinical Trial Physician II- Cell Therapy is the primary source of medical accountability and oversight for multiple clinical trials or a single trial with significant complexity within the Cell Therapy Global Drug Development organization.
The incumbent will be accountable, alongside the Clinical Development Team Lead, for the development of differentiated and strategic CDPs from phase I expansion through to registrational execution.
They will be foundational in working with teams in Research, Early and Late Development to providing insights into biology, translational elements as well as overall benefit risk assessments.
This role includes support of across portfolio activities in line with Clinical Excellence, including Protocol Review Committee, support of Business Development activities and Quality and compliance leadership.
The Senior Clinical Trial Physician II sits within Clinical Development, which is a global organization dedicated to the effective design and execution of drug development.
Clinical Development drives clinical development strategy, design, execution, and interpretation of clinical trials.
The sCTP II - Cell Therapy will report directly to the Clinical Development Team Leader - Cell Therapy and will deputize as required as a core member of the Cell Therapy Global Program Team.
Position
Summary:
Serves as a primary source of medical accountability and oversight for multiple clinical trials or a single trial with significant complexity within the Cell Therapy Global Drug Development organization Supervises the development, monitoring, analysis, and interpretation of clinical trials and will supervise and have accountability for the clinical components of regulatory filings.
Will contribute to overall cell therapy disease strategy for specific tumor types while ensuring a franchise overall portfolio view.
Provides strategic insights into the clinical development plans Provides medical and scientific expertise to cross-functional BMS colleagues Matrix management responsibilities across the internal and external network Manages Phase 1 to Phase 3 clinical studies, with demonstrated decision-making capabilities This role will include above disease / indication strategy work (i.
e.
Disease / Indication Strategy teams) The role will be foundational in working with teams in Research, Early and Late Development teams to support GT4/5 and POC transitions, providing insights into biology, translational elements as well as overall benefit risk assessments The role includes support of across portfolio activities in line with Clinical Excellence, including e.
g.
Protocol Review Committee, support of Business Development activities and Quality and Compliance leadership Technical/Functional
Responsibilities:
Clinical Development Expertise & Strategy A Senior Clinical Trial Physician II is a tenured drug developer who can independently design and construct clinical development plans and protocols with a strong strategic focus based on knowledge of asset/drug, disease area and relevant science in order to meet regulatory and disease strategy targets.
Done in conjunction with Clinical Development Team Lead or as a delegate when CDTL is not assigned Extensive experience in Research and Development (late and/or early development) and across various Phases of study design (FIH, study start-up, study execution, DBL & close-out) Oversees trial(s) within asset class or multiple trials across assets (ie Immunotherapy, targeted therapy, mABs, ADCs, CAR T, etc) & across various diseases with in-depth clinical development expertise Respected for Disease Expertise (internal to BMS and within the medical community) Disease Lead- able to serve as internal consultant for respective disease(s) based on scientific knowledge and therapeutic expertise Provides oversight and medical accountability for a group of high-priority studies Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment working with Clinical Scientists (CS) 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.
) Existing strong relationships with principal investigators.
Identifies and cultivates thought leaders in order to gain their inputs on emerging science in drug and biomarker research, disease knowledge, and design of clinical development studies and programs Keeps abreast of development and regulatory issues related to other competitive or relevant compounds in development and how our portfolio fits into the competitive landscapeSenior CTP II should be able to anticipate impact of external data which may shift internal clinical strategy and proactively assess needs for internal program (ie amendments, need for ad hoc analyses & implications to execution of internal programs) Provides ongoing medical education in partnership with collaborating Clinical Scientists to allow for protocol-specific training, supporting the study team, investigators, and internal stakeholders (ie medical affairs, commercial, translational medicine, access, etc) Medical Monitoring Leader of high performing Study Delivery Team (SDT) and key member of the Clinical Development Team (CDT) Study-Leader with ability to own/drive study level strategic decisions Leads medical data review of trial data, including eligibility review Holds responsibility for site interactions in partnership with the Clinical Scientist (CS) for medical questions and education (including safety management guidelines) Holds responsibility for assessment of key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversees safety narratives Leads collaboration with CS and inputs into protocols, providing 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 Onboarding Lead - provides guidance and training to new CTP (not limited to data management; systems training), therapeutic training, innovative study design and sets example of high proficiency for the organization Health Authority Interactions & Publications Serves as medical point of expertise in key Health Authority interactions and advisory board meetings as Clinical Trial Physician Authors 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 CSs Experience with regulatory submission & development of clinical sections in regulatory documents for submission across several markets Ability to lead strategic framework for clinical sections of regulatory documents Exceptional clinical response strategist for queries (written & oral) Stakeholder Engagement and Communication Will work closely with colleagues in BMS IO CT TRC, CT Correlative Research Team, Research & Discovery, Early and Late Development, Regulatory, Medical, Commercial and other key functional areas on a global basis; additionally, should have an external focus and build relationships with thought leaders, physicians, and patient advocacy groups outside of BMS.
Be recognized internally and externally as an expert in the field.
Partner and interact with colleagues from Research and Early Development who design and implement first in human through proof-of-concept trials and will assure a seamless transition into late-stage development (Phase II-III trials.
) Ability to influence leadership and upper management of key functions (e.
g.
, early development, TM, clinical pharmacology, toxicology, regulatory, HEOR, market access, medical affairs), applying foresight, scientific and development knowledge to ensure support of late clinical development needs and adequacy of clinical studies leading to registration
Qualifications:
EXPERIENCE/TECHNICAL BACKGROUND AND KNOWLEDGE MD (or ex-US equivalent) The ideal candidate will be a Clinical Development leader; with greater than 5 years of extensive clinical trial and drug development experience and regulatory experience, in addition to a strong scientific background.
Deep understanding of Biology, targets and translational science.
Extensive experience of work with health authorities at all levels.
The candidate also must be a highly effective leader capable of working with Commercial, Medical, and all research functions of the company from Research through Regulatory.
The candidate must be comfortable with cross-functional drug and product development teams and managing in a matrix environment.
Global experiences since this position has responsibility for strategy and clinical research in oncology in multiple geographies.
Key Competency Requirements:
Ability to communicate information clearly and lead presentations in scientific and clinical settings Subspecialty training in applicable therapeutic area desired Expertise in the scientific method to test hypotheses, including statistical design, analysis, and interpretation Expertise in drug development process Expertise in 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 Ability to work independently & prioritize work (self-starter / takes initiative) Takes ownership and accountability Embodies collaborative-spirit, enterprise mindset & ability to see what's needed to be successful in the future Enterprise mindset with strong understanding of development priorities across programs, studies, expenses and cross-functional workstreams Travel required:
domestic and international travel may be required The starting compensation for this job is a range from $308,000-$354,000, 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 the where the job is performed.
Final individual compensation will be decided based on demonstrated experience.
For more on benefits, please visit our Working With Us (bms.
com)Eligibility for specific benefits listed on our BMS Careers site may vary based on the job and location.
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.
Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as Transforming patients' lives through science(TM) , 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.
On-site ProtocolPhysical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
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.
If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to email protected .
Visit careers.
bms.
com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities.
As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Recommended Skills Biology Business Development Clinical Research Clinical Works Consulting Data Management Estimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
