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.

At Bristol Myers Squibb, we’re creating innovative medicines for patients who are fighting serious diseases. We’re also nurturing our own team with inspiring work and challenging career options. No matter our role, each of us makes a contribution. And that makes all the difference.

The Manager II, Finance Planning & Analysis Commercialization Markets for BMS will be a highly collaborative Finance business partner. This exceptional team member will perform FP&A activities for the market in BMS’s Hyderabad Hub

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.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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: Senior Manager, Biostatistics 

Location: Hyderabad, IN

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, cell therapy, immunology 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 Manager of Biostatistics is a member of cross-functional study/project teams and contributes to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions. These individuals develop collaborative relationships and work effectively with the Biostatistics Lead, and other cross functional team members. 

Key Responsibilities 

• Contributes to designing clinical trials to address study hypotheses and objectives. 

• Authors and/or reviews protocol synopsis, protocol, statistical analysis plan, data presentation plan, case-report forms, clinical study reports, associated publications, and other study level specification documents under supervision. 

• Performs and/or validates preplanned or ad hoc statistical analyses with guidance as needed. 

• Presents & interprets results to GBDS and/or cross-functional team members. 

• Translates scientific questions into statistical terms and statistical concepts into layman terms.  

• Compliant with BMS processes and SOPs, adherence to global and project standards within an indication or therapeutic area and responsible for quality of deliverable. 

• Continually develops technical knowledge of statistical methodology and how it is appropriately applied in trial design and data analysis for clear, concise, high-quality results. 

• Effectively communicates the GBDS Mission and Vision in a fashion that generates pride, excitement and commitment within GBDS.  

• 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.  

Qualifications & Experience 

• MS in statistics, or biostatistics or related scientific field with 1-2 years’ experience in clinical trials, drug development, pharmaceutical industry or healthcare experience (including internship) preferred. 

• Proficiency in scientific computing/programming (SAS, R or Python) and implementation of statistical analysis, data manipulation, graphing & simulation. 

• Good interpersonal, communication, writing and organizational skills  

•  Ability to: 

• learn regulatory requirements & clinical trial design, data analysis and interpretation, 

• work successfully within cross-functional teams,  

• organize multiple work assignments and establish priorities 

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.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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.

Job Summary-

Reconcile and Prepare Clinical Trial Submission documents adhering to regulatory guidelines and ensuring consistency across all BMS programs

Responsibilities-

• In conjunction with the Submission Manager, and use of technologies, simplify the end-to-end process for Clinical Trial documents, maintenance and submissions
• Prepare Clinical Trial Submission documents adhering to regulatory guidelines and ensuring consistency across all BMS programs. 
• Partners with the Submission Manager for the timing and creation of the submission documents, including CSR appendices, Financial Disclosure Tables, and related submissions documents.
• Ensures documents  are formatted  appropriately and Submission Ready Compliant (SRC)
• In collaboration with out outsourced partners, creates  site numbers for  new and ongoing clinical trials.
• Enters site milestones and regulatory approvals dates to maintain the quality health of the trail assigned to.
• Ensures Drug shipment address are entered correctly, and feed to SAP to enable IP Supply to sites.
• Performs a reconciliation of Veeva (eTMF/CTMS) to ensure accurate data is available and reflecting correctly.
• Proactively analyzes and drives efficient problem solving within team's control.
• Applies critical thinking, developing mitigation and resolution strategies, and promptly responding to action items.
• Demonstrates thorough knowledge of relevant BMS SOPs and policies and the ability to provide timely guidance in their application to Protocol and/or Program teams. Assesses operational feasibility using GCPs, ICH and regulatory legislation and guidelines as they apply to submission deliverables where applicable.
• Demonstrates strong project management skills
• Demonstrates thorough knowledge of creation of documents, and the document management systems and requirements (e.g. Core Template).
• Demonstrate understanding of the pharmaceutical industry and of the non-clinical, clinical, business, ethical and regulatory components in the global drug development process.
• Manages interactions with senior level multifunctional teams across the oncology portfolio, to drive the operations submission documents.
• Other duties as assigned to support Clinical Trials.
• Performs other tasks as assigned.
  
   

Experience Required-

• 2-4 years of relevant experience in clinical trial documentation management or a Clinically related or relevant field.
• Demonstrated knowledge of ICH / GCP and regulatory guidelines/directives, understanding of drug development process and Pharma.
• Experience in the use of industry Clinical Trial Master File Systems or equivalent. Experience with Veeva Vault Clinical preferred
• Experience with MS office suite, SharePoint, etc. CTMS (Veeva Vault experience preferred), knowledge of portals, databases and other Clinical Trial enabling technologies.

Strong understanding of the pharmaceutical industry and of the non-clinical, clinical, business, ethical and regulatory components in the global drug development process.

Key Compitencies-

• Strong organizational, time-management, analytical and decision-making skills to efficiently evaluate, plan and accomplish work goals.
• Effective management or support of cross-functional, multi-cultural teams and demonstrated ability to work and influence within a matrix structure.
• Proven time management skills and ability to be flexible to meet job demands, manage multiple priorities, and take on new initiatives and improvement efforts.
• Ability to sustain high levels of performance in a constantly changing environment.
• Demonstrates a high level of adaptability in dealing with ambiguous and complex work environment and balances multiple demands on role in a responsive and professional manner.
• Ability to prioritize work and assess risk to meet the needs of the organization. 
• Demonstrated ability to work independently and seek out support when needed. 
• Proactive, adaptable and able to modify personal and organizational work style to meet the needs of the business. 
• Strong understanding of the pharmaceutical industry and of the non-clinical, clinical, business, ethical and regulatory components in the global drug development process.
• Strong understanding of GCPs, ICH and regulatory regulations and guidelines as they apply to protocol management and program strategy.
• Understands the influences of safety and efficacy profiles, labeling, legislation and marketing on the life cycle of a compound.
• Strong understanding of protocol-related documents, and document management systems (e.g. CORE template).
• Ability to manage complex issues and proactively apply critical thinking to address challenges. Some positions may require experience in a specific therapeutic area.
• Exceptional written and oral communication skills. 

#DDHYD #HYBRID

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.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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.

The KAM is a critical role in our unique customer model to execute the BMS aspiration to be the BioPharma that delivers the most impactful engagement with Health Care Providers (HCPs), driving adoption of new and existing medicines for appropriate patients.
The primary role of the KAM is to drive demand for BMS medicines within their portfolio for the appropriate patients. To meet the HCPs expectations, the KAM engages them with a differentiated Customer Experience (Cx) through deeper scientific dialogue on and consistent with label, leveraging new ways of working and CE^3.

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.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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.

负责辖区内公司产品在临床的宣传和推广工作，执行公司的产品策略及学术推广活动，并达成公司的业务目标。

•      有深入的产品知识和疾病领域知识

•      达成/超越区域目标

•      执行市场经理阐明的市场战略。从恰当的细分市场里甄别出目标HCP并与之合作, 达成推广计划

•      充分了解所在地区和所负责区域的关键HCPs

•      更新客户数据

•      协调当地的“院内会议”

•      及时更新HCP的信息，根据计划进行拜访。

•      建立和维护和关键HCP的联系, 理解客户(医学)需求。

•      达成并保持公司关于拜访率、知识水平、能力、行为和个人形象方面的要求。

•      定期（每天）在ETMS 系统中报告拜访情况。

•      提供准确的报告，并且根据规定的流程联系直接主管。

•      提供给直接主管关于BMS 推广材料有效性的信息。.

•      通过参加培训、会议、和自学医学文献以发展和提高专业知识

•      和团队成员分享自己的知识和经验。

•      管理好专业设备和促销资料，确保完好。

为公司树立良好的专业形象，对公司商业秘密做到保密，确保在工作中, 严格遵守公司的各项规章制度，保证自己的行为符合公司的道德原则和合规准则。

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.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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.

负责辖区内公司产品在临床的宣传和推广工作，执行公司的产品策略及学术推广活动，并达成公司的业务目标。

•      有深入的产品知识和疾病领域知识

•      达成/超越区域目标

•      执行市场经理阐明的市场战略。从恰当的细分市场里甄别出目标HCP并与之合作, 达成推广计划

•      充分了解所在地区和所负责区域的关键HCPs

•      更新客户数据

•      协调当地的“院内会议”

•      及时更新HCP的信息，根据计划进行拜访。

•      建立和维护和关键HCP的联系, 理解客户(医学)需求。

•      达成并保持公司关于拜访率、知识水平、能力、行为和个人形象方面的要求。

•      定期（每天）在ETMS 系统中报告拜访情况。

•      提供准确的报告，并且根据规定的流程联系直接主管。

•      提供给直接主管关于BMS 推广材料有效性的信息。.

•      通过参加培训、会议、和自学医学文献以发展和提高专业知识

•      和团队成员分享自己的知识和经验。

•      管理好专业设备和促销资料，确保完好。

为公司树立良好的专业形象，对公司商业秘密做到保密，确保在工作中, 严格遵守公司的各项规章制度，保证自己的行为符合公司的道德原则和合规准则。

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.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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.

The KAM is a critical role in our unique customer model to execute the BMS aspiration to be the BioPharma that delivers the most impactful engagement with Health Care Providers (HCPs), driving adoption of new and existing medicines for appropriate patients.
The primary role of the KAM is to drive demand for BMS medicines within their portfolio for the appropriate patients. To meet the HCPs expectations, the KAM engages them with a differentiated Customer Experience (Cx) through deeper scientific dialogue on and consistent with label, leveraging new ways of working and CE^3.

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.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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.

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.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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.

Functional Area Description

• The Worldwide Patient Safety (WWPS) group is responsible for ensuring the safety of our medicines. WWPS pharmacovigilance and pharmacoepidemiology deliverables include single case and aggregate safety monitoring, safety reporting, contributing to benefit-risk assessment, risk management planning and strategy, execution of certain post marketing commitments, and ensuring compliance with global regulatory requirements.

Position Summary

• Lead safety activities and benefit-risk strategies for assigned BMS compounds/programs in the Immunology Therapeutic Area (TA) and chair the product Safety Management Team(s).
• Oversee, prepare, and/or review aggregate safety review documents as well as safety sections of relevant clinical trial documents and regulatory filings.
• Lead team in the evaluation & management of signals emerging from any data source. Develop strategy for signal evaluation and document outcome.
• Lead safety labeling activities for assigned products/program. Act as the Safety Subject Matter Expert for input to regulatory product labeling. Participate/provide input at cross-functional labeling team meetings and provide regional safety labeling support.
• Lead process improvement projects. Assist the Medical Safety Assessment (MSA) TA Head/Lead in developing and maintaining state-of-the-art Pharmacovigilance (PV) processes and procedures within BMS Drug Development and WWPS.
• Support the EU Qualified Person for PV or other regional or local Qualified Person for PV relative to issues relating to assigned products.
• Provide input to Drug Development publication strategy/plan & ensure safety input to publications/presentations.
• Actively drive safety strategy preparation and represent WWPS at Health Authority (HA) and Data Monitoring Committee (DMC) meetings.
• Ensure that the above tasks are performed in the most efficient manner possible commensurate with quality, accuracy, and timeliness and in accordance with current global regulatory requirements and BMS cost effectiveness goals.
• Promote collegiality and teamwork among peers. Mentor/support colleagues as a positive change agent.

Position Responsibilities

General Product Support

• Lead safety activities and benefit-risk strategies for assigned BMS compounds and chair the product SMT(s).
• Oversee, prepare, and/or review aggregate safety review documents (e.g., Development Safety Update Reports [DSUR], Periodic Benefit-Risk Evaluation Reports [PBRER]) and safety sections of relevant clinical trial documents (e.g., protocols, clinical study reports [CSR], investigator brochures [IB], informed consent forms [ICF]) and regulatory filings (e.g., clinical trial applications, marketing authorization applications).
• Lead team in evaluation & management of signals emerging from any data source. Develop strategy for signal evaluation (egg, case-series, literature review, HA/ claims database). Document by Safety Topic Review/ Signal Report or other means of communication.
• Lead safety labeling activities for assigned products. Act as the Safety Subject Matter Expert for input to regulatory product labeling. Participate/provide input at cross-functional labeling team meetings and provide regional safety labeling support.
• Support the EU QPPV or other regional or local Qualified Person for PV relative to issues relating to assigned products.
• Provide input to Drug Development publication strategy/plan & ensure safety input to publications/presentations.

Clinical Development

• Act as the global safety lead for assigned compounds in development. Provide safety lead support for global submission document production. Review draft summary documents.
• Lead medical safety development and execution of benefit-risk management strategies for assigned products.
• Provide safety input to clinical development plans, study protocols, amendments, IB, statistical analysis plan, ICF, CSR, responses to HA or institutional review board/ ethics committee queries.
• Lead development of safety risk language, risk management strategy, pre-filing safety activities including safety table shells, integrated safety data review, integrated safety summary document review, and safety-focused publication development.
• Perform medical safety review of DSUR, annual reports and other periodic safety submissions.
• Support safety strategy preparation for pre-submission meetings, Advisory Committee meetings, Scientific Advice meetings, DMC meetings, etc.
• Post marketing Support
• Act as the safety lead for assigned marketed compounds and support global post marketing safety activities and submissions.
• Provide medical safety, benefit-risk input for safety aggregate reports, product renewal submissions, post marketing study documents and reports, responses to HA queries.
• Lead medical safety oversight of and execution of risk management strategies and RMP elements for assigned products.
• Lead safety signal evaluation & management. Prepare and review reports on safety signals (ie, Safety Topic Reviews/Signal Reports) and ad hoc regulatory responses.
• Provide post marketing safety study guidance to other groups including epidemiology and medical affairs including but not limited to investigator-sponsored research, epidemiology studies, and non-interventional safety studies.
• Ensure safety labeling adequately reflects emerging post marketing safety profile.

Department Activities

• Lead process improvement projects. Assist the MSA TA Head/Lead in developing and maintaining state-of-the-art PV processes and procedures within BMS Drug Development and WWPS.
• Support preparation for regulatory inspections with evaluation of current processes and assess alignment with regulatory expectations, guidelines, and mandates.
• Assist the team and senior management in all forms of issue management and crisis management.
• Liaise with all TA staff and maintain an effective and collaborative patient safety team.
• Support hiring & orientation.

Cross-Functional Activities

• Provide input to strategic plans for safety differentiation of BMS products.
• Prepare and provide training to BMS employees on product safety profiles/issues.
• Act as WWPS liaison for assigned products with BMS functions (Legal, Business Development, Operations, Marketing, etc.).
• Support manufacturing quality. Co-Author integrated health hazard assessments.
• Develop communications of safety data & interpretation to BMS and external parties, globally.

Degree Requirements

• MD/equivalent required. Postgraduate qualification or experience in internal medicine, immunology, or related specialty desirable.
• Experience Requirements
• 3+ years in PV or relevant pharmaceutical or biomedical field (eg, Medical, Clinical, Regulatory) is strongly preferred. Other relevant experiences & accomplishments considered, such as roles in clinical research, observational research & clinical practice experience.

Key Competency Requirements

• Understanding of the drug development process.
• Knowledge of PV and ability to apply knowledge to evaluation of safety concerns and minimization of patient risk throughout the life cycle of a drug product.
• Proficient ability to leverage the range of available tools to investigate safety concerns, including the science of observational research.
• Understanding of regulatory requirements for safety assessment and action.
• Strong scientific analytical reasoning skills.
• Ability to work on multiple projects in parallel.
• Excellent attention to detail.
• Behavioral competencies necessary to work and lead within a complex matrix environment.
• Excellent verbal and written communication skills.

  Functional Area Description

• The Worldwide Patient Safety (WWPS) group is responsible for ensuring the safety of our medicines. WWPS pharmacovigilance and pharmacoepidemiology deliverables include single case and aggregate safety monitoring, safety reporting, contributing to benefit-risk assessment, risk management planning and strategy, execution of certain post marketing commitments, and ensuring compliance with global regulatory requirements.

​​Position Summary

• Lead safety activities and benefit-risk strategies for assigned BMS compounds/programs in the Immunology Therapeutic Area (TA) and chair the product Safety Management Team(s).
• Oversee, prepare, and/or review aggregate safety review documents as well as safety sections of relevant clinical trial documents and regulatory filings.
• Lead team in the evaluation & management of signals emerging from any data source. Develop strategy for signal evaluation and document outcome.
• Lead safety labeling activities for assigned products/program. Act as the Safety Subject Matter Expert for input to regulatory product labeling. Participate/provide input at cross-functional labeling team meetings and provide regional safety labeling support.
• Lead process improvement projects. Assist the Medical Safety Assessment (MSA) TA Head/Lead in developing and maintaining state-of-the-art Pharmacovigilance (PV) processes and procedures within BMS Drug Development and WWPS.
• Support the EU Qualified Person for PV or other regional or local Qualified Person for PV relative to issues relating to assigned products.
• Provide input to Drug Development publication strategy/plan & ensure safety input to publications/presentations.
• Actively drive safety strategy preparation and represent WWPS at Health Authority (HA) and Data Monitoring Committee (DMC) meetings.
• Ensure that the above tasks are performed in the most efficient manner possible commensurate with quality, accuracy, and timeliness and in accordance with current global regulatory requirements and BMS cost effectiveness goals.
• Promote collegiality and teamwork among peers. Mentor/support colleagues as a positive change agent.

Position Responsibilities

General Product Support

• Lead safety activities and benefit-risk strategies for assigned BMS compounds and chair the product SMT(s).
• Oversee, prepare, and/or review aggregate safety review documents (e.g., Development Safety Update Reports [DSUR], Periodic Benefit-Risk Evaluation Reports [PBRER]) and safety sections of relevant clinical trial documents (e.g., protocols, clinical study reports [CSR], investigator brochures [IB], informed consent forms [ICF]) and regulatory filings (e.g., clinical trial applications, marketing authorization applications).
• Lead team in evaluation & management of signals emerging from any data source. Develop strategy for signal evaluation (egg, case-series, literature review, HA/ claims database). Document by Safety Topic Review/ Signal Report or other means of communication.
• Lead safety labeling activities for assigned products. Act as the Safety Subject Matter Expert for input to regulatory product labeling. Participate/provide input at cross-functional labeling team meetings and provide regional safety labeling support.
• Support the EU QPPV or other regional or local Qualified Person for PV relative to issues relating to assigned products.
• Provide input to Drug Development publication strategy/plan & ensure safety input to publications/presentations.

• Clinical Development

• Act as the global safety lead for assigned compounds in development. Provide safety lead support for global submission document production. Review draft summary documents.
• Lead medical safety development and execution of benefit-risk management strategies for assigned products.
• Provide safety input to clinical development plans, study protocols, amendments, IB, statistical analysis plan, ICF, CSR, responses to HA or institutional review board/ ethics committee queries.
• Lead development of safety risk language, risk management strategy, pre-filing safety activities including safety table shells, integrated safety data review, integrated safety summary document review, and safety-focused publication development.
• Perform medical safety review of DSUR, annual reports and other periodic safety submissions.
• Support safety strategy preparation for pre-submission meetings, Advisory Committee meetings, Scientific Advice meetings, DMC meetings, etc.
• Post marketing Support
• Act as the safety lead for assigned marketed compounds and support global post marketing safety activities and submissions.
• Provide medical safety, benefit-risk input for safety aggregate reports, product renewal submissions, post marketing study documents and reports, responses to HA queries.
• Lead medical safety oversight of and execution of risk management strategies and RMP elements for assigned products.
• Lead safety signal evaluation & management. Prepare and review reports on safety signals (ie, Safety Topic Reviews/Signal Reports) and ad hoc regulatory responses.
• Provide post marketing safety study guidance to other groups including epidemiology and medical affairs including but not limited to investigator-sponsored research, epidemiology studies, and non-interventional safety studies.
• Ensure safety labeling adequately reflects emerging post marketing safety profile.

Department Activities

• Lead process improvement projects. Assist the MSA TA Head/Lead in developing and maintaining state-of-the-art PV processes and procedures within BMS Drug Development and WWPS.
• Support preparation for regulatory inspections with evaluation of current processes and assess alignment with regulatory expectations, guidelines, and mandates.
• Assist the team and senior management in all forms of issue management and crisis management.
• Liaise with all TA staff and maintain an effective and collaborative patient safety team.
• Support hiring & orientation.

Cross-Functional Activities

• Provide input to strategic plans for safety differentiation of BMS products.
• Prepare and provide training to BMS employees on product safety profiles/issues.
• Act as WWPS liaison for assigned products with BMS functions (Legal, Business Development, Operations, Marketing, etc.).
• Support manufacturing quality. Co-Author integrated health hazard assessments.
• Develop communications of safety data & interpretation to BMS and external parties, globally.

Degree Requirements

• MD/equivalent required. Postgraduate qualification or experience in internal medicine, immunology, or related specialty desirable.
• Experience Requirements
• 3+ years in PV or relevant pharmaceutical or biomedical field (eg, Medical, Clinical, Regulatory) is strongly preferred. Other relevant experiences & accomplishments considered, such as roles in clinical research, observational research & clinical practice experience.

Key Competency Requirements

• Understanding of the drug development process.
• Knowledge of PV and ability to apply knowledge to evaluation of safety concerns and minimization of patient risk throughout the life cycle of a drug product.
• Proficient ability to leverage the range of available tools to investigate safety concerns, including the science of observational research.
• Understanding of regulatory requirements for safety assessment and action.
• Strong scientific analytical reasoning skills.
• Ability to work on multiple projects in parallel.
• Excellent attention to detail.
• Behavioral competencies necessary to work and lead within a complex matrix environment.
• Excellent verbal and written communication skills.

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.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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.

The Informed Consent (IC) Management function at BMS sits within Global Development Operations (GDO) and is responsible for managing the end-to-end process for IC for BMS-sponsored clinical trials. This includes a centralized triage function for informed consent negotiations with global clinical trial sites, IRBs/ECs, and health authorities, as well as management of templates, processes, and technology to support implementation of informed consent in our trials. This team is evolving the BMS approach to informed consent by leveraging internal and external best practices and exploring technologies.

The Associate Director (AD), Informed Consent Management role reports to the Director of Informed Consent Management. The AD will be responsible for informed consent activities and will also serve as the Global Process Lead for IC at BMS. The AD will be responsible for triaging and addressing questions and requests for IC language changes supporting our global clinical trials and will be responsible for IC codification to document permissions and restrictions associated with specimens and data. The AD will also assist in the development of processes, procedures, templates, and technology to facilitate informed consent as well as lead process optimization to align with the QMS document hierarchy.

RESPONSIBILITIES:

• Central triage of all study, county, and site level language modifications.

• Review and process language modifications and engage with relevant stakeholders per BMS SOPs. Manage escalations key stakeholders, as appropriate.

• Track and assign requests for language modifications, ethics committee or health authority queries related to IC or other supporting materials.

• Identify and resolve complex consent issues and mentor junior team members.

• Drive collaboration with cross-functional teams across BMS to ensure both patient safety and quality, and specimen and data compliance.

• Independently liaise with Regional Country Operations to ensure adherence to local laws/regulations/requirements.

• Use critical thinking to solve problems and exercise good judgment.

• Serve as the Global Process Lead for Informed Consent.

• Drive the development and continuous improvement of policies, procedures, processes, and support technology solutions to aid in the execution of a compliant process.

• Develop and maintain, in collaboration with stakeholders and SMEs, BMS Global IC templates for use in BMS-sponsored clinical trials.

• Ensure appropriate governance and oversight is in place and effective for the IC templates.

• Collaborate with cross-functional teams in and outside of GDO in order to ensure both patient safety and quality are the foundations of the IC processes.

• Provide subject matter expertise and oversight on the IC process in support of clinical operations, including during audits and inspections.

• Establish objectives, strategies, priorities and plans to ensure appropriate governance, oversight and compliance to the process. 

• Collaborate with Outsourcing Management team to develop appropriate process and communications with Clinical Research Organizations and other external partners to ensure compliance with applicable requirements for the IC.

• Working with management and Global Quality to foster a cross functional mindset of Quality Excellence, Quality by Design, Inspection Readiness at all times, and Growth Mindset.

• Partnering with the Training, Process and Continuous Improvement team to ensure appropriate training is current.

• Keep abreast of the changing regulatory landscape and engage externally as appropriate with industry consortia.

REQUIRED QUALIFICATIONS AND EXPERIENCE:

• Bachelor's degree with a concentration in a scientific- or technical-related discipline. Master’s degree preferred.

• At least 6-8 years in the pharmaceutical industry and 3-5 years of experience in clinical operations and/or Good Clinical Practice, with direct experience related to informed consent required.

• Proficient understanding of Good Clinical Practice (GCP) and Human Subject Research requirements.

• Thorough understanding of company policies and regulatory requirements, and their relation to the management and documentation of compliance issues related to patient rights and data privacy.

• Strong program and project management experience with proven track record of several years managing cross-functional programs and ability to manage multiple, simultaneous projects.

• Demonstrated innovation, flexibility, open-mindedness, and adaptability to meet objectives in a rapidly changing global environment with shifting priorities.

• Experience with partner management.

• Experience in process improvement methodology and Lean Sigma is a plus with a mindset for Simplification.

• Knowledge of IT systems used to support clinical trial processes and the authoring of clinical trial related documentation is desirable.

• Good understanding of the drug development process and clinical operations, experience in risk management, audits and health authority inspections, root cause analyses and mitigation strategies as well as Corrective Actions Preventive Actions (CAPA) process.

• Experience in matrix management is required at all levels in the organization.

• Ability to engage and inspire others at all levels in the organization.

• Excellent communication skills with a proven ability to effectively engage and manage key internal stakeholders at all levels (in various functions and geographies) as well as external stakeholders (including Health Authorities).

• Excellent presentation and negotiation skills with the ability to resolve conflict in a timely and constructive manner.

• Ability to manage multiple projects simultaneously to ensure timely, on budget execution of tasks. Attention to detail with excellent planning, time management and organizational skills.

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.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.