Job Search Results
Working with Us
Challenging. 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.
High Level Summary:
The Japan Clinical Trial Physician sits within Clinical Development, which is dedicated to the effective design and execution of drug development. Clinical Trial Physician contributes and drives clinical development strategy, design, execution, and interpretation of clinical trials closely working with Japan Clinical Leads and global clinical counterpart.
Role Description
Medical Monitoring
- Conducts medical data review of trial data, including eligibility review
- Holds responsibility for site interactions in partnership with the Japan Clinical Lead or Clinical Scientist for medical questions and education (including safety management guidelines)
- Holds responsibility for assessment of key safety-related serious adverse events of R&D clinical trials in partnership with Worldwide Patient Safety and oversees safety narratives
- Collaborate with Japan Clinical Lead or Clinical Scientist 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
- The range of CTP’s medical accountability/responsibility differs in global vs local studies. For global studies, Japan CTP is assumed to assist global CTP as needed from local perspectives, e.g. provide local medical related input, resolve local medical related issues.
- Japan CTP could be expected to take a primary CTP role for local initiated trials or program
Clinical Development Expertise & Strategy
- In collaboration with the Japan Program Development Team such as Clinical Lead, designs and develops project/clinical 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
- Provides oversight and medical accountability for a group of studies
- Leads the analysis of benefit/risk for clinical development protocols and projects in a matrix team environment working with Japan TA
- Partners with Japan the Japan Program Development Team such as Clinical Lead to support executional delivery of studies (e.g., enrollment review, as well as adjudication for protocol violations, significant, non-significant deviations etc.)
- Identifies and builds 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
- Maintains a strong medical/scientific reputation within the disease area. Has in-depth knowledge of etiology, natural history, diagnosis, and treatment of the disorder. Holds strong expertise 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 collaborating Clinical Scientists to allow for protocol-specific training, supporting the study team, investigators, and others
Health Authority Interactions & Publications
- Contributes to and serves as medical point of expertise in key Health Authority interactions and advisory board meetings as Clinical Trial Physician
- 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 TA such as Clinical Lead or Clinical Scientist
Required Capability:
- Ability to deliver the outcomes under the ambiguity or complexity
- Ability to partner with people at all levels of the organization
- Ability for proactive proposal building and proactive action takings without detailed instructions
- Ability to respond flexibly to the changing project/task priorities and work assignments.
- Ability to influence and negotiate without specific authority.
- Ability to take a risk and to manage it without jeopardizing quality and/or compliance
- Ability to build action plans based on the organization vision
- Acts to makes a balance between short-term performance and long-term vision.
Required Knowledge / Experiences:
- Deep/extensive knowledge on all over clinical development that is equivalent to 5-10 year-experiences
- Broad knowledge on full process of pharmaceutical development and its regulatory guidance/guidelines
- Ability to propose and execute improvement and innovation in TA and cross-TA works
- Skills of budget planning and resource management
- Good communication skills in both Japanese and English
- Strong leadership qualities with the ability to create a culture of collaboration and teamwork that fosters open communication, constructive conflict, and organizational flexibility
- Excellent interpersonal skills, with the ability to build relationships, act as a change agent, and adapt to rapidly changing organizational and business issues
- Broad and in-depth understanding of domestic and international issues relative to the industry
- Experience to assure business compliance and control within the compliance obligations, Sarbanes Oxley and other audit requirements
- Expertise in the components needed to execute an effective clinical plan and protocols
Others
Fluent in spoken and written English & Japanese for business is preferred
Requirement:
MD is required, Ph.D. is highly recommended
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 Careers
With 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.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
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 adastaffingsupport@bms.com. 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.
Working with Us
Challenging. 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.
High Level Summary:
The Japan Clinical Trial Physician sits within Clinical Development, which is dedicated to the effective design and execution of drug development. Clinical Trial Physician contributes and drives clinical development strategy, design, execution, and interpretation of clinical trials closely working with Japan Clinical Leads and global clinical counterpart.
Role Description
Medical Monitoring
- Conducts medical data review of trial data, including eligibility review
- Holds responsibility for site interactions in partnership with the Japan Clinical Lead or Clinical Scientist for medical questions and education (including safety management guidelines)
- Holds responsibility for assessment of key safety-related serious adverse events of R&D clinical trials in partnership with Worldwide Patient Safety and oversees safety narratives
- Collaborate with Japan Clinical Lead or Clinical Scientist 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
- The range of CTP’s medical accountability/responsibility differs in global vs local studies. For global studies, Japan CTP is assumed to assist global CTP as needed from local perspectives, e.g. provide local medical related input, resolve local medical related issues.
- Japan CTP could be expected to take a primary CTP role for local initiated trials or program
Clinical Development Expertise & Strategy
- In collaboration with the Japan Program Development Team such as Clinical Lead, designs and develops project/clinical 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
- Provides oversight and medical accountability for a group of studies
- Leads the analysis of benefit/risk for clinical development protocols and projects in a matrix team environment working with Japan TA
- Partners with Japan the Japan Program Development Team such as Clinical Lead to support executional delivery of studies (e.g., enrollment review, as well as adjudication for protocol violations, significant, non-significant deviations etc.)
- Identifies and builds 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
- Maintains a strong medical/scientific reputation within the disease area. Has in-depth knowledge of etiology, natural history, diagnosis, and treatment of the disorder. Holds strong expertise 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 collaborating Clinical Scientists to allow for protocol-specific training, supporting the study team, investigators, and others
Health Authority Interactions & Publications
- Contributes to and serves as medical point of expertise in key Health Authority interactions and advisory board meetings as Clinical Trial Physician
- 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 TA such as Clinical Lead or Clinical Scientist
Required Capability:
- Ability to deliver the outcomes under the ambiguity or complexity
- Ability to partner with people at all levels of the organization
- Ability for proactive proposal building and proactive action takings without detailed instructions
- Ability to respond flexibly to the changing project/task priorities and work assignments.
- Ability to influence and negotiate without specific authority.
- Ability to take a risk and to manage it without jeopardizing quality and/or compliance
- Ability to build action plans based on the organization vision
- Acts to makes a balance between short-term performance and long-term vision.
Required Knowledge / Experiences:
- Deep/extensive knowledge on all over clinical development that is equivalent to 5-10 year-experiences
- Broad knowledge on full process of pharmaceutical development and its regulatory guidance/guidelines
- Ability to propose and execute improvement and innovation in TA and cross-TA works
- Skills of budget planning and resource management
- Good communication skills in both Japanese and English
- Strong leadership qualities with the ability to create a culture of collaboration and teamwork that fosters open communication, constructive conflict, and organizational flexibility
- Excellent interpersonal skills, with the ability to build relationships, act as a change agent, and adapt to rapidly changing organizational and business issues
- Broad and in-depth understanding of domestic and international issues relative to the industry
- Experience to assure business compliance and control within the compliance obligations, Sarbanes Oxley and other audit requirements
- Expertise in the components needed to execute an effective clinical plan and protocols
Others
Fluent in spoken and written English & Japanese for business is preferred
Requirement:
MD is required, Ph.D. is highly recommended
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 Careers
With 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.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
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 adastaffingsupport@bms.com. 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.
Working with Us
Challenging. 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.
Position Summary
Lead digitization of manufacturing process in collaboration with business functions and IT partners. Manage MES and surrounding system’s life cycle from plan, build to retirement. It is also responsible for MES administration, recipe management, and support as well as surrounding systems.
Key Responsibilities
Manage operations:
- Establish solid relationships with business teams and work with them to build and implement digitization strategy in manufacturing process area.
- Lead and manage system implementation project as a IT business partner to make sure the deliverables are meeting intended use and released as planned.
- Maintain and support manufacturing systems throughout the lifecycle by:
- Coordinating activities with internal and external IT partners such as global GPS IT, Emerson, Accenture, HCL, BT, and workplace services, etc.
- Monitoring the systems are in validated state and if the changes deviate from it, work with change management and CSV teams to handle their risks appropriately.
- Occasionally assessing support activities are perceived with satisfaction from business.
- Administrate MES system environments in user access management, its periodic review, and security configuration.
Manage MES recipe in the following responsibilities:
Lead recipe delivery process.
Support global recipe management strategy to maximize reuse of recipes and/or recipe segments across sites.
Build recipes that are designed around simplicity, flexibility, and cost effectiveness.
Partner with MS&T and Process Robustness team to configure recipes in support of analytics.
Manage people (consultants and partners to begin with):
- Communicates continuously site strategies and project objectives.
- Delivers results and drives for continuous improvement. Has high performance expectations and holds others accountable for results. Acts with a sense of urgency.
- Demonstrates strong team leadership, able to work with a wide variety of people.
- Lead and manage change initiatives that supports IT technology and process changes.
- Broker IT business solutions that achieves site needs and links to global strategies, solutions, practices, and systems where appropriate.
Manage finance:
- Effectively manages the given budgetary targets in his/her scope are met.
- Justifies proposals for additional expenditure.
- Achieves effective financial control through management of project scope, estimating, effective use of SAP and budget control tools, risk management and project close out.
- Understanding of financial management as it relates to capital and expense spending.
Qualifications & Experience
- At least 2 years’ direct experience of designing, building, deploying, and supporting automation and execution systems (Syncade, PI Data historian, etc.) in regulated manufacturing environments.
- Strong domain expertise in the application of IT to manufacturing, including a broad understanding of processes and how they are supported by IT tools and systems.
- Strong knowledge of regulatory landscape and demonstrated experience with software validation.
- Proven track record of successful IT/automation project delivery.
- Substantial managerial experience and well developed social and technical skills.
- Ability to work across global sites and cultures.
- Fluent in Japanese and English – verbal and written communications.
- A minimum of 2-3 years IT experience supporting manufacturing plants is preferred (ideally 3-5 years). In-depth knowledge of regulatory compliance is 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.
Uniquely Interesting Work, Life-changing Careers
With 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.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
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 adastaffingsupport@bms.com. 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.
Manufacturing/Ops
Working with Us
Challenging. 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.
PURPOSE AND SCOPE OF POSITION:
The Manufacturing Operations Manager I/II leads a team of front-line supervisors that execute the cell therapy manufacturing process. Team scope is organized around cell therapy manufacturing unit operations such as media, selection, activation, or harvest which are executed in accordance with Current Good Manufacturing Practices (cGMP’s) in both a clinical and commercial setting. The Manufacturing Operations Manager II is responsible for managing all aspects of the manufacturing unit operation team including the people (Manager IIs and associates), written procedures, patient and intermediate materials, equipment, and environment of the production area.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
Education:
- Bachelor’s degree in relevant science or engineering discipline and/or equivalent combination of work experience is required.
Experience
- 5-8+ years of relevant biologics or cell therapy manufacturing experience.
- Minimum of 2 years of leadership experience including the supervision of direct reports is required.
Knowledge, Skills, and Abilities
- Proven proficiency in coaching and developing front line leaders is required.
- Extensive knowledge of SOPs, cGMPs, and the experience to work and manage within a regulated environment.
- Demonstrates aptitude for engineering principles and manufacturing systems.
- Adaptable to a fast paced, complex, and ever-changing business environment.
DUTIES AND RESPONSIBILITIES:
Key Responsibilities
Establish and/or manage a Manufacturing team at Jump.
This includes:
- Hiring, mentoring, and developing exceptional individual contributors and front-line leaders.
- Aid in driving leadership vision and decision-making alignment across teams’ groups within manufacturing.
- Championing a culture of teamwork and communication across the organization
- Ensuring people have the appropriate level of training for system and processes in manufacturing
- Building effective cross-functional relationships both internally within the Manufacturing Leadership Team and externally across Jump.
- Ensuring a culture that embraces the safety of the work environment and the safety of the patients by compliance with company procedures and policies, and cGMP requirements
- Provides oversight of the execution of manufacturing unit operations. These operations include but are not limited to the use of the following equipment and or systems including manufacturing equipment, process automation systems (i.e., Unicorn and BAS) and supporting business systems (i.e., Oracle, Infinity, BMRAM).
- Establishing department goals, tracking, and reporting KPIs, and driving continuous improvement efforts
- Designing and operating manufacturing systems that are technically sound, promoting effective and efficient operations, and complying with cGMP requirements
- Ensuring the schedules of the people, facility, equipment, materials, and documents are established and maintained to support the capacity/throughput of the facility
- Identifying and mitigating risks in manufacturing operations that could negatively impact delivery of safe and effective therapies to patients
- Championing inspection readiness efforts
- Establishing team policies, organizational structure, shift structure, and career ladders.
- Reviewing and approving documents, including standard operating procedures, batch records, material specifications, and validation protocols / reports
- Ensuring deviations, CAPA, change controls, process transfers, and other business drivers are supported
- Driving right first time (RFT) culture and executes manufacturing unit operations by providing direct training, guidance, and problem solving.
- Ensuring that projects, change controls, process transfers and other business drivers are collectively supported within peer group.
- Ensuring that communications delivered to staff member levels are accurate, consistent, and fit to vision within the functional area supervisory group.
Shift Schedule:
Sunday - Wednesday 5:00 AM - 5:30PM, alternate Wednesday
The starting compensation for this job is a range from $92,000 - $129,000, plus incentive cash and stock opportunities (based on eligibility).
The starting pay takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation is decided based on demonstrated experience.
For more on benefits, please visit our BMS Careers site.
Eligibility for specific benefits listed in our careers site may vary based on the job and location.
Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. 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. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
WORKING CONDITIONS (US Only):
- Must be able to work in a cleanroom environment that requires gowning.
- Must be able to stand for extended periods of time.
- Work in areas that may have strong magnets.
- Work in areas where handling human blood products (Biosafety Level 2) may be required.
- May work in areas with exposure to vapor phase liquid nitrogen.
- If required, must be able to work nights, weekends, mandatory bi-weekly overtime, and holidays in a 12-hour shift structure.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
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 Careers
With 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.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
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 adastaffingsupport@bms.com. 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.
Working with Us
Challenging. 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.
RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.
The Sr. Director of Engineering is an integral part of bringing RayzeBio’s innovative drug products to patients in need. In this role, you will report directly to the Vice President, Site Head and be responsible for building and leading a multi-functional engineering department in support of clinical development and the commercialization of isotope and radiopharmaceutical drug products. You will spearhead the design and construction of internal and external cleanroom and facility construction projects. You will set and manage capital project budgets and oversee Construction, Architectural and Engineering firms to ensure projects are executed to meet budget and timeline objectives. You will establish and oversee a highly competent engineering department with expertise in a wide range of radiopharmaceutical technologies, validation, facility maintenance and engineering management. You will build an experienced engineering team to manage multiple capital projects to support the commercialization efforts of RayzeBio’s drug product candidates. This position will be based in Indianapolis, IN.
Responsibilities:
Build and manage a team of highly talented engineers responsible for all aspects of engineering, capital projects, validation and facility maintenance.
Oversee and manage a wide range of engineering capital and facility expansion projects specific to radiopharmaceutical manufacturing.
Set and manage engineering project budgets and timelines.
Oversee the design and construction of existing facility expansion and future commercial facility projects.
Implement engineering and related business systems in alignment with BMS’s corporate objectives.
Establish an Engineering Services department responsible for maintaining and troubleshooting complex manufacturing equipment and processes, providing technical guidance and support to team members.
Establish an engineering infrastructure to provide cross departmental project and capital equipment support including but not limited to URS, Purchase, Installation, and Preventative Maintenance.
Coordination of external vendors, partners and service providers as required.
Ensure Engineering personnel comply with site EHS and Radiation Safety programs and promote a culture of safety.
Review, author and/or revise technical documents (SOPs, URS’s, forms, etc.) as needed.
Ability to travel as required to support job role.
Education and Experience:
10+ years’ engineering experience in a cGMP injectable or Radiopharmaceutical environment is required.
Proven engineering leadership and management experience.
BS/MS Engineering Degree.
Skills:
Strong track record managing capital engineering projects and budgets.
Proven leadership and personnel management experience.
Strong knowledge of injectable and/or radiopharmaceutical drug product manufacturing.
Excellent professional ethics, integrity, and ability to maintain confidential information.
Organized and detail oriented.
Strong time management and organizational skills.
Strong interpersonal communication skills.
Motivated, adaptable, and able to work under pressure.
Physical Requirements:
Standard office environment coupled with GMP production and facility environment.
Responsibilities also include the ability to lift up to 50 lbs., walk, bend, stoop, push, pull, reach, and climb stairs with or without accommodation.
Ability to sit or stand for long periods of time while performing duties.
Must be willing to wear personal protective equipment (PPE) as required.
Must be comfortable working with radioactive materials.
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 Careers
With 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.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
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 adastaffingsupport@bms.com. 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.
Drug Dev and Preclinical Studies
Working with Us
Challenging. 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.
When you join BMS, you are joining a diverse, high-achieving team united by a common mission.
The Non-Clinical Safety and Veterinary Sciences organization enables the safe conduct of clinical studies and marketing applications while applying the core underlying principles of robust science & problem solving, 3R’s (reduce, replace, and refine), animal welfare, and quality & compliance to our nonclinical efforts. While focusing on transforming patients’ lives through science, we intend to be an industry-leading nonclinical safety evaluation, laboratory animal science and medicine organization with high scientific, quality, & employee safety standards.
The Bristol-Myers Squibb department of Veterinary Sciences located in the San Francisco Bay Area is seeking a Senior Staff Veterinarian to join a dynamic, fast-paced team involved in all aspects of the veterinary care program. This role will be based in Brisbane, CA and will support vivaria in multiple locations across the US West Coast. In this position, the successful candidate will enable in vivo research in the Cancer Immunology and Cell Therapy, Oncogenesis, Cardiovascular, and Discovery Biotherapeutics Thematic Research Centers.
The Senior Staff Veterinarian’s role will include providing high-quality veterinary care and consultation for our Discovery sites in the Bay Area, San Diego, and Seattle. Clinical duties will include disease surveillance, prevention, and treatment, with a strong emphasis on rodent population medicine. The qualified candidate will contribute to the development and continuous improvement of internal policies and practices and will be responsible for ensuring full compliance with all applicable animal welfare regulations and guidelines. In addition, the successful applicant will serve as a member of the IACUC and will participate in protocol review, routine inspections, and the post-approval monitoring program (PAM).
The ideal candidate will have a strong commitment to animal welfare, promotion and transparency of biomedical research, the 3Rs, and will be actively engaged in the BMS Culture of Care. The candidate will be expected to demonstrate and model strong collaborative skills across sites and teams and will directly contribute to team success at all sites. Additionally, the ideal candidate will have experience working independently on clinical veterinary cases and be able to assist with training staff on the veterinary care and husbandry of research animals as mandated by federal law, regulations, accreditation standards, and internal policies.
Key Responsibilities
- Maintain high quality health care and records for all laboratory animals.
- Author standard operating procedures, guidelines, and research reports.
- Review IACUC protocols and provide veterinary consultation to the IACUC as needed.
- Provide professional consultations and scientific support to investigators.
- Participate in the rodent health monitoring and vendor animal health quality assurance programs.
- Provide supervision of Veterinary Scientists.
- Implement staff training and development to support regulatory compliance.
- Participate in a rotating on-call schedule for weekend, holiday, and emergency coverage.
- Provide leadership, guidance, and engagement to ensure site compliance with all applicable local and federal regulations and guidelines, and to support ongoing AAALAC accreditation and USDA registration.
- Provide oversight and consultation for in vivo studies conducted by external partners and offer opportunities for refinement as appropriate.
- Assist with experimental protocol design.
Qualifications & Experience
Required Qualifications:
- DVM or VMD or equivalent plus a current license to practice veterinary medicine in the US.
- Understanding of the biology and medicine of laboratory animals as acquired by completion of a post-doctoral program in laboratory animal medicine or another veterinary specialty is strongly desired.
- Knowledge of regulatory requirements and guidelines for the care and use of laboratory animals.
- Applicable clinical experience with a wide range of species.
- Practical understanding of the use of personal protective equipment to prevent injuries and exposure to zoonotic agents.
- Exemplary communication and interpersonal skills and ability to reach independent, reasoned solutions.
- Ability to successfully collaborate and develop effective working relationships with research and VS staff from diverse educational and technical backgrounds.
- Desire to contribute to a translationally-focused R&D team with a focus on the patient.
- Travel required to support Bay Area, Seattle, WA and San Diego, CA sites will be required. Travel for training or other business needs with consecutive nights away from home may additionally occur.
Preferred Qualifications:
- Board certification or board eligibility from the American College of Laboratory Animal Medicine (ACLAM) or other recognized AVMA specialty certification is strongly preferred.
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 Careers
With 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.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
For California Sites - The starting compensation for this job is a range from $168,000 – $193,000, plus incentive cash and stock opportunities (based on eligibility). The starting pay takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation is decided based on demonstrated experience. For more on benefits, please visit our BMS Careers site. Eligibility for specific benefits listed in our careers site may vary based on the job and location.
Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. 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. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
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 Careers
With 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.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
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 adastaffingsupport@bms.com. 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.
Clinical Development
Working with Us
Challenging. 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.
Manager, eCOA (Electronic Clinical Outcome Assessment) Management
Division
Research and Development (R&D), Global Development Operations (GDO), Global Data Management (GDM)
Functional Area Description
Global Data Management (GDM) is responsible for clinical trial data acquisition, data management and review, and medical coding for trials across the BMS R&D portfolio.
Position Summary
The Manager, eCOA Management role is essential to the study-level operationalization of the eCOA capability for BMS clinical trials, directly contributing to the BMS R&D pipeline. This role reports to the Associate Director, eCOA Management within GDM and is a full-time, office-based position with flexibility to work from home up to 50% of the time.
Position Responsibilities
- Provide leadership for the operationalization of eCOA instruments for clinical trials, facilitating the end-to-end process, and working with clinical study teams and vendors to meet study requirements.
- Work with eCOA vendors to ensure eCOA development is planned and executed effectively, both for initial deployment and post-production updates, ensuring timely delivery and issue resolution.
- Collaborate with stakeholders to ensure contracts, licenses, and translations are executed for timely eCOA delivery.
- Review and coordinate study-level eCOA process documents with clinical study team members.
- Oversee eCOA development and testing activities, ensuring requirements are well-defined and met.
- Resolve eCOA issues during study conduct in collaboration with study team members and vendors.
- Ensure effective quality oversight and management of external partners performing eCOA activities on behalf of BMS.
- Manage work assignments to ensure timely delivery.
- Identify and resolve issues that may negatively impact delivery of work, seeking support from leadership as needed.
- Follow procedural documents when completing deliverables.
- Participate in continuous improvement activities as required.
- Support preparations and follow-up actions related to Health Authority inspections and internal audits for assigned studies.
- Develop strong and productive working relationships with key stakeholders throughout GDM, GDO, and BMS.
Degree Requirements
- Bachelor's degree required.
Experience Requirements
- At least 4 years of relevant industry and clinical trial experience, including at least 3 years of specific experience with eCOA technologies, instruments, and end-to-end operationalization of eCOA.
Key Competency Requirements
- Good understanding of the drug development process with proven expertise in clinical trial start-up/execution and eCOA operationalization in a global arena.
- Solid technical expertise in eCOA processes, instruments, and clinical data acquisition/integration.
- Knowledge of industry-leading tools and emerging technologies supporting eCOA.
- Good knowledge of GCP/ICH guidelines.
- Technical expertise, technical writing ability, and proficiency in Systems Development LifeCycle (SDLC) principles.
- Demonstrated partnership across collaborative forums.
- Ability to self-start, be solution-oriented, collaborate effectively with stakeholders, and be accountable for results.
Travel Requirements
Potential need for periodic travel.
Work Environment
N/A
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 Careers
With 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.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
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 adastaffingsupport@bms.com. 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.
Clinical Development
Working with Us
Challenging. 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.
Senior Manager, eCOA (Electronic Clinical Outcome Assessment) Management
Division
Research and Development (R&D), Global Development Operations (GDO), Global Data Management and Centralized Monitoring (GDM)
Functional Area Description
Global Data Management (GDM) is responsible for clinical trial data acquisition, data management and review, and medical coding for trials across the BMS R&D portfolio.
Position Summary
The Senior Manager, eCOA Management role is essential to the study-level operationalization of the eCOA capability for BMS clinical trials, directly contributing to the BMS R&D pipeline. This role reports to the Associate Director, eCOA Management within GDM and is a full-time, office-based position with flexibility to work from home up to 50% of the time.
Position Responsibilities
- Provide leadership for the operationalization of eCOA instruments for clinical trials, facilitating the end-to-end process, and working with clinical study teams and vendors to meet study requirements. Handle complex and high-priority studies.
- Work with eCOA vendors to ensure eCOA development is planned and executed effectively, both for initial deployment and post-production updates, ensuring timely delivery and issue resolution.
- Collaborate with stakeholders to ensure contracts, licenses, and translations are executed for timely eCOA delivery.
- Review and coordinate study-level eCOA process documents with study team members.
- Oversee eCOA development and testing activities, ensuring requirements are well-defined and met.
- Resolve eCOA issues during study conduct in collaboration with study team members and vendors.
- Ensure effective quality oversight and management of external partners performing eCOA activities on behalf of BMS.
- Manage work assignments to ensure timely delivery.
- Identify and resolve issues that may negatively impact the operationalization of eCOA tools, using collaborative strategies, and escalate issues to leadership when necessary.
- Follow procedural documents and participate in reviewing and updating them to reflect industry standards and regulatory requirements.
- Train and mentor newer team members on key activities and processes.
- Actively participate in and/or lead continuous improvement activities.
- Support preparations and follow-up actions related to Health Authority inspections and internal audits.
- Develop strong and productive working relationships with key stakeholders throughout GDM, GDO, and BMS, with the ability to think strategically across a broad portfolio.
- Represent the Company in interactions with key external partners as part of any committee or industry group relating to database development.
Degree Requirements
- Bachelor's degree required.
Experience Requirements
- At least 5 years of relevant industry and clinical trial experience, including specific experience with eCOA technologies, instruments, and end-to-end operationalization of eCOA.
Key Competency Requirements
- Solid understanding of the drug development process with proven expertise in clinical trial start-up/execution and eCOA operationalization in a global arena.
- Strong technical expertise in eCOA processes, instruments, and clinical data acquisition/integration.
- Knowledge of industry-leading tools and emerging technologies supporting eCOA.
- Strong knowledge of GCP/ICH guidelines.
- Experience with reviewing technical documents, writing documents, and applying Systems Development LifeCycle (SDLC) and system validation principles.
- Demonstrated partnership across various collaborative forums and with external partners.
- Diverse technical expertise to interface with global development and business partners (medical, development, commercial, regulatory, quality).
- Ability to self-start, be solution-oriented, collaborate effectively with stakeholders, drive activities to completion, and be accountable for results.
Travel Requirements
Potential need for periodic travel.
Work Environment
N/A
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 Careers
With 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.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
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 adastaffingsupport@bms.com. 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.
Information Technology
Working with Us
Challenging. 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.
At BMS, digital innovation and Information Technology are central to our vision of transforming patients’ lives through science. To accelerate our ability to serve patients around the world, we must unleash the power of technology. We are committed to being at the forefront of transforming the way medicine is made and delivered by harnessing the power of computer and data science, artificial intelligence, and other technologies to promote scientific discovery, faster decision making, and enhanced patient care.
If you want an exciting and rewarding career that is meaningful, consider joining our diverse team!
Desired Candidate Characteristics
- Have a strong commitment to a career in technology with a passion for healthcare.
- Ability to understand the needs of the business and commitment to deliver the best user experience and adoption.
- Able to collaborate across multiple teams.
- Demonstrated leadership experience.
- Excellent communication skills
- Innovative and inquisitive nature to ask questions, offer bold ideas and challenge the status quo.
- Agility to learn new tools and processes.
Key Responsibilities
- Develop and sustain a Commercialization focused information and data strategy and appropriate data management strategy in collaboration with appropriate stakeholders including Data Governance, Data Stewardship, Data capabilities, Reporting & Analytics Platform team(s), capability teams, Business, Insights & Analytics and Commercialization business.
- Develop and sustain target information architecture and roadmap(s) for Commercialization business.
- Develop Commercialization specific data architecture principles, guidelines, and standards.
- Drive information architecture decisions on Commercialization data flows, conceptual data models, ontologies/taxonomies and hierarchies as needed to support the Commercialization data supply chain in partnership with various IT and functional teams.
- Ensure that the target information and data architecture is understood and implemented by the relevant IT Capability Delivery Team(s).
- Represent Commercialization IA at key operating mechanisms like the Architecture forums, Data Governance and Privacy Councils, etc. as needed.
- Develop sustainable, reusable design patterns and best practices that can be leveraged by the delivery teams.
- Advocate data security and the appropriate use of information and data within the target information and data architecture.
- Develop and maintain source to target mappings as appropriate.
- Understand and evaluate current and emerging data, analytic and reporting technology trends. Coordinate proof of concepts in partnership with the appropriate build team(s).
Qualifications & Experience
- Requires advanced knowledge applicable to a wide range of work in own function and thorough knowledge of other functions, typically gained through a university degree and 5+ years of experience.
- May lead initiatives related to continuous improvement or implementation of new technologies. Works independently on most deliverables.
- Demonstrates ability to build and leverage relationships through diplomacy with a broader focus within the Function.
- Articulates and presents complex information clearly and concisely across all levels. Ability to demonstrate in-depth knowledge and expertise thereby establishing a strong reputation for themselves and the team.
- Participates in decision making and brings a variety of strong views and perspective to achieve team objectives.
- Looks for challenging opportunities and focus on building strong capabilities. Encourages and coach others to do the same.
- Demonstrates a focus on improving processes, structures and knowledge within the team. Leads in analyzing current states, deliver strong recommendations in understanding complexity in the environment, and the ability to execute to bring complex solutions to completion.
- Recognizes the potential impact on internal/external challenges on the future state success. Conveys and takes immediate action to correct any variation in quality, ensures accuracy and completeness of others' work outputs.
- Demonstrates sophisticated analytical thought using various data sources and internal/external environment. Understands the broader implications of actions and perspective. Synthesizes results and links patterns and trends. Considers lessons learned and best practices in conveying to the team's understanding and knowledge.
Why You Should Apply
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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 Careers
With 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.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
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 adastaffingsupport@bms.com. 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.
Working with Us
Challenging. 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.
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, cell therapy, immunology, Neuroscience, and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Position Summary
The Senior Director of Real-World Evidence Biostatistics plays a pivotal role in leading and overseeing the strategic direction and execution of statistical and real-world evidence initiatives within the organization. This key leadership position involves providing guidance and expertise in statistical methodologies, study design using real-world data to facilitate and support development and regulatory interactions of pharmaceutical products. The Senior Director collaborates closely with cross-functional teams to drive innovation, optimize trial design, and leverage real-world data to support evidence generation and decision-making. Additionally, the role involves representing the organization in interactions with regulatory agencies, fostering a culture of excellence and continuous improvement within the Global Biometrics and Data Sciences, and serving as a thought leader in the field of real-world evidence.
Key Responsibilities
Provide strategic leadership in the design, execution, and analysis of real-world evidence studies
Lead efforts to enhance the utilization of real-world data for evidence generation and decision-making purposes
Represent the organization at conferences, forums, and industry events to showcase expertise and thought leadership in biostatistics and real-world data
Manages resources and budget to ensure company resources are allocated according to the development needs and priorities
Creates effective processes related to RWE and ensures consistency and adherence across therapeutic areas and projects
Key contributor to Clinical Development Plans, submissions, and post-submission strategies/preparation/ defense as needed
Represents the company in interfaces with regulatory agencies globally
Effectively engages as a matrix team member on high-level development teams and serves as a scientific and strategic partner
Seeks and establishes new collaborations with cross-functional teams for RWE objectives
Enables a culture of inclusiveness, respect for diversity, compliance with process and allows for the questioning and challenging of others in a respectful and constructive manner
Provides leadership to empower and develop the team
Provides guidance to employee's development plans and carries out performance review and feedback. develops performance metrics for staff
Qualifications & Experience
PhD or MS (12+ years’ experience) in statistics or biostatistics or related scientific field with clinical trials, drug development, pharmaceutical industry or healthcare experience
Proficiency in scientific computing/programming (SAS, R or Python) and implementation of advanced statistical analysis
Extensive experience in real-world data within the pharmaceutical or CRO industry, demonstrating a strong track record of leadership and strategic thinking.
In-depth knowledge of statistical methodologies, clinical trial design, and real-world evidence generation, with a focus on optimizing study design and data analysis
A commitment to continuous learning and professional development in the field of real-world data
Experience in preparing and participating in global regulatory agency interactions
Demonstrate excellent collaboration, organizational/ leadership abilities, and interpersonal skills
At least 5 years management (direct or matrix) experience is preferred
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 Careers
With 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.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
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 adastaffingsupport@bms.com. 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.