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

Senior Director, Risk Management and Central Monitoring Position is a critical member of the Clinical Oversight and Risk Management Leadership Team and accountable to develop and drive Risk Based strategies to enable the efficient and effective execution of clinical trials through monitoring and data oversight. Key strategic and tactical activities include the execution of the strategic vision for the organization, and to enable a highly efficient and engaged organization through operational directives and key initiatives.

The role is accountable for defining the RBM strategy, collaborating with stakeholders to ensure buy in and leading the Risk Management and Central Monitoring team, responsible for supporting delivery of reliable clinical trial information for internal decision making, regulatory approval and market acceptance, and ensure a holistic community of practice centered on quality by design, clinical trial risk management, efficient issue management, and continuous improvement.

The role will need to play an instrumental role in collaborating and negotiating with VP level peers in the broader Drug Development organization to facilitate risk discussion at portfolio level and would operate for a specific TA The insights that come from the RM_CM TA specific team will be used for decision making at site, study, country, portfolio level.  

The Senior Director, Risk Management and Central Monitoring, is an industry thought leaders and seeks understanding of what industry best practice is and is engaged in industry leading forums for bringing industry standards in centralized monitoring into BMS.

This role is expected to be in office 50% of the time over 2 weeks per company policy.

Key Responsibilities
- Drive the development of and deliver the vision, strategy and road map, in partnership with the CORM LT, to build a holistic and integrated Risk Management and Central Monitoring capability and processes to drive proactive risk-based management and related data insights that enable BMS Drug Development to accelerate in performance and safeguarding the well-being of our trial participants.

- Lead and shape the Risk Management and Central Monitoring TA specific team, enabling them to lead execution of the Risk Based Management Framework, enhancement of quality, compliance and inspection readiness across the clinical trials (Phase 1-4) in the portfolio.

- Lead and manage governance for ongoing review of portfolio risk to support successful delivery of  

portfolio priorities for specific TA

-Is accountable for implementing an effective quality by design and risk-based management approach.

- Accountable for monitoring holistic quality of GDO activities across the portfolio, identifying risks and supporting functions to remediate gaps.

-GDO point of contact for Quality oversight in RBM implementation, driving best practice and improved quality for clinical trials

- Seeks understanding of what industry best practice is and is engaged in industry leading forums for bringing industry standards in centralized monitoring into BMS.

-Accountable for the identification and/or escalations of significant operational, quality and compliance risks within established risk management framework and councils. Participates in investigations and mitigation measures.

- Develops strong and productive working relationships with key stakeholders throughout BMS, demonstrates the ability to think strategically across R&D, and effectively influence peers and senior management.

- Collaborates with Global Development Operations, Quality Assurance, and process owners to ensure that processes, SOPs, oversight, and governance meet the needs of the organization and evolving regulatory expectations.

- Provides leadership and oversight to the Risk Management and Central Monitoring process and audits ensuring quality readiness for regulatory inspections.

- Develop and implement the strategy to incorporate automation and emerging technologies to support risk identification and management.

- Provides ongoing feedback, coaching, and career development, including engagement and retention support to staff in order to maximize their potential.  Empower and hold staff to high quality performance and delivery.

- Engages and energizes employees through communication of goals, priorities and other business critical information as well as focus on employee value proposition, development and retention activities.

- Develop and promote a workplace culture that values diversity of thought, promotes integrity, and creates an atmosphere that supports coaching and fosters accountability.

Qualifications & Experience
-A minimum of a Bachelor’s degree (or equivalent degree) is required

-Degree in a life science, natural science, or business is preferred

-Broad knowledge of the global drug development processes is required, with at least 10 years GCP-related experience in clinical operations (e.g. site, sponsor, and/or CRO).

- Would operate for a specific TA' so would have relevant TA experience to shape thinking.

-Inspection experience is a plus

-Experience in and/or knowledge of centralized monitoring and risk management in a regulated industry.

-Enterprise Risk Management knowledge is preferred

-Experience in managing teams of diverse individuals, ability to operate in a matrix organization and manage competing priorities with a sense of urgency.

- Engaged in industry leading forums related to risk management and central monitoring.

-The candidate will demonstrate the ability to adopt a biopharma enterprise-wide mindset, to act with speed, accountability, and integrity.

- Demonstrated team and matrix leadership, escalation, enterprise and senior leadership alignment.

- Knowledge of external health authority and industry trends and emerging areas of interest.

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.

Employer:       Bristol-Myers Squibb Company

Position:          Sr. Manager (ref.# 4250)

Location:         3551 Lawrenceville Road, Princeton, NJ 08540

Duties: Assist management in the collection and assessment of global submission metrics of ICSRs (Individual Case Safety Reports) and SARs (Safety Aggregate Report) to assure compliance with proper regulations and continuous improvement mechanism of trending of CAPA (corrective and preventative actions) by drawing on experience with case processing; gathering and creating CAPA; pharmacovigilance (PV); safety reporting; adverse event reporting principles; and PVAs (Pharmacovigilance Agreements). Conduct thorough and careful analysis of ICSR global compliance for trending/tracking of root causes to assess global compliance risks. Responsible for global SAR (Safety Aggregate Report) metric collation and distribution. Partners with the PV Compliance and Quality Risk Management organization to proactively identify opportunities for process improvement to increase the effectiveness and efficiency of the WWPS (Worldwide Patient Safety) organization. Ensure adequate and timely escalation of incidents/issues and/or potential deviations. Lead formal investigations of issue as they arise, ensuring timely escalation to line management if critical observations or critical issues are not resolved. Provide guidance during the development and execution of CAPA relating the submission issues. Coordinate and review CAPAs to ensure adequate root cause analysis and systemic solutions. Collaborate with WWPS stakeholders innovate processes associated with the timely submission processes. Ensure continued inspection readiness in area of expertise. May work remotely 3 days per week within normal commuting distance of Princeton, NJ.

Requirements: Master’s degree in Pharmaceutical Sciences, Psychology or a related field plus 5 years of post-baccalaureate experience reflecting demonstrable ability in the skill set described above. The required skills do not need to be maintained over the full term of required experience.

The starting compensation for this job is $186,306/year, plus incentive cash and stock opportunities (based on eligibility).

The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Career Site.

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 BMS Careers Site link is not copy and pasting correctly, please add manually using the following address: https://jobs.bms.com/careers/join.

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.

This position is the Senior Frontend Developer, Authoring Platform within the Commercialization IT function, responsible & accountable for leading and contributing on viable technical solution design, development/configuration & deployment in accordance with a release management plan. The key responsibilities would go across investment projects and operational changes for bug fixes/enhancements, and innovation projects supporting organizational goals.

• Partner with the leads of Commercialization IT and the broader IT matrix organization with a focus on solution design, development, and implementation of digital authoring tools, for new and existing capabilities, to drive effective content creation and better customer engagement & experience.
• Collaborate with IT partners and business teams to understand requirements and use cases. Improve or align requirement outcomes to deliver successful release for new initiatives and enhancements.
• Actively drive the development life cycle of digital tactics from requirement analysis, feasibility estimates and design to implementation, testing, and support (HTML5, CSS3, JavaScript).

• Understanding of Veeva Vault PromoMats and MedComms development processes. Strong knowledge & hands on experience managing the end-to-end content lifecycle i.e., content creation, content storage, content review & approval, content assembly/authoring & content distribution.
• Responsible for regular coaching and training for depth of knowledge of Jr Developer team to match Veeva Vault and BMS technology need and job growth. Set training objectives and ensure knowledge success or certifications.
• Work in conjunction with all development teammates to contribute towards requirement grooming, documentation, UT test plan, ST and UAT during release.
• Provide hands-on L2/L3 support for applications and dependent apps. Assist with tracking, logging, monitoring, and driving to resolution of end user issues.
• Design/Conduct Proof of Concepts (POCs) with user management, security, data privacy & performance as key considerations to help prove out/establish a potential digital capability solution to scale into production.
• Demonstrate the ability to identify high value capabilities with clear differentiators when making digital capability platform choices. Identify opportunities for continuous improvement.
• Shared responsibility for ensuring that all development functions are successful in their delivery of services to support the digital solutions enablement of the Omni-Channel Capabilities group. Key matrix IT partner functions include data architecture, cyber security, data privacy office, application build & support, portfolio & program management, collaboration services, infrastructure services etc.

• Commercialization (Commercial + Medical) domain & Digital Capability Solutions development experience.
• Excellent collaboration and communication skills, with the ability to build strong partnerships. Ability to clearly articulate and translate technical elements in business terms. Demonstrated ability to partner with leaders.
• Working knowledge of software-development lifecycle methodologies including Agile, Lean, Waterfall etc.
• Passionate with a desire to quickly learn new technologies, self-motivated & ready to drive technology solutions. 
• Strong understanding of Validated Delivery and GxP standards. Should be willing join teammates strategically and hands-on to deliver proper requirements, functional design documents, Trace Matrix, and test scripts.
• Experience with creating/maintaining standard documentation such as SDD, Configuration Tracker, Deployment Checklists, Change Requests etc.  
• Ability to clearly document Knowledge Base Documents, SOPs, User Manuals/Training Materials for local and global teams.  
• Hands-on experience with Veeva system integrations and content authoring tools.
• Solid understanding of Veeva CRM application, especially as it integrates with PromoMats and MedComms.
• Experience with effectively using the CI/CD processes to streamline and integrate with the AGILE ways of working/delivery. 
• Proponent of following all the best practices in every stage of SDLC including consistent architecture practices across deliverables using IT operating model and Enterprise Architecture frameworks. 
• Should be able to closely work with a diverse set of teams spread across different locations globally that would comprise of BMS resources as well as Service Providers. 

Required Qualifications

• Bachelor’s Degree in Computer Science, Information Technology, or related field with 5+ years of progressively responsible experience in an IT technical role.
• 5+ years of experience in web development: HTML/CSS, JavaScript/Typescript, Vue.js/React.js, Pinia
  Git/GitHub/SVN, NPM/Pip, Axios/Fetch API to integrate with APIs, Vite, Docker, AWS S3 webkit, Tailwind css, Basic Python, Figma, command line tools, IDE (VSCode, Pycharm), SQL, VeevaCRM, Veeva Vault, Salesforce, jQuery and working with databases
• Knowledge of e-Wizard authoring tool a plus

• Exposure Veeva API connection and coding for functionality enhancements and integration.
• Knowledge of multi-channel content distribution to CRM (Veeva CLM and Approved Email Admin Certification).
• Strong knowledge of Vault content load in Vault (and manual in Veeva CRM).
• Strong analytical and problem-solving skills. 
• Familiarity with and awareness of the Pharmaceutical Industry.
• Demonstrates strong presentation, persuasion and influencing 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.

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 reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team.

The Specialist, QA Operations Deviation role will be responsible for providing quality oversight for site manufacturing operations and quality control laboratory operations at the Summit S12 Cell Therapy manufacturing facility, in accordance with Bristol Myers Squibb policies, standards, procedures and Global cGMP. Functional responsibilities for the incumbent include ensuring accurate and timely maintenance and review of procedures and methods; providing compliance oversight; ensure accurate and timely review of manufacturing and laboratory investigations; and identifying any trends.

Shift Available:

• Sunday - Wednesday, Onsite, 4 p.m. - 2 a.m.

Responsibilities:

• Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner.

• Review all data in accordance with applicable procedures and cGMP requirements.

• Anticipate and troubleshoot problems.  Communicate effectively with management regarding task completion, roadblocks, and needs.

• Support document revision, project, CAPA, and investigation/deviation related tasks.

• Perform assigned tasks within a CAPA, deviation, or project.

• Participate in projects and continuous improvement efforts.

• Perform other tasks as assigned.

• Support for QC and manufacturing operations requires shift coverage consisting of weekdays, weekends, holidays, and during adverse weather conditions. 

• Ability to adapt to multiple changing priorities.

Knowledge & Skills:

• Must have knowledge and experience with US and global cGMP manufacturing, Quality, and Compliance.

• Understanding and competence in quality processes, including but not limited to material disposition, deviations, investigations, and CAPA management.

• Supports quality initiatives that accomplish continuous improvement and enhance site manufacturing efficiencies, while providing a safe and compliant process.

• Must have strong authorship and be able to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.

• Must be able to note technical/scientific attributes in potential situations or issues and process science-based solutions across most of the job function.

• Must provide guidance to other employees in the interpretation of technical/scientific issues.

• Must possess an independent mindset and tenacity.

Basic Requirements:

• Bachelor’s degree required, preferably in science-based field. 

• 1-2 years Quality Control and/or Quality Assurance experience in a pharmaceutical company with CAR T or Biologics experience.

• 1-2 years of minimum within a manufacturing GMP environment.

• Good technical writing skill-set.

Preferred Requirements:

• Advanced degree, in a science area.

• Knowledge of LIMS and laboratory data analysis systems.

• Support in Health Authority Inspections.

• Ability to understand the manufacturing process of both Abecma and Breyanzi.

BMSCART, #LI-Onsite

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.

The Principal Scientist Stability is responsible for stability product strategy and oversight of product stability programs for commercial small molecules Drug Substances and Drug Products. Activities include those associated with product stability strategy, stability program requirements, authoring / approving stability protocols, and preparation, review and approval of stability reports and regulatory filings.

The Principal Scientist Stability will work closely with QC commercial, Quality Operations and External Quality, MS&T, Regulatory CMC and interface with CMOs.

Duties/ Responsibilities:

• Manage the Stability program for assigned brands, act as Stability Product Lead

• Develop and maintain expertise on the overall stability performance of products manufactured in the global supply chain, including maintaining a working knowledge of the attributes that impact the products’ performance/stability profile

• Participates on transfer team for new products to internal and external sites (as required), reviews registrational stability studies and conducts gap analysis against Global Manufacturing & Supply requirements.  Develops stability data where gaps exist.

• Serves as stability representative on project teams covering post-approval changes, designs and executes required premarket stability program in support of the change

• Perform change control impact assessments and document the stability assessment in change controls.  Review and endorse change controls as an expanded reviewer. Initiate change controls related to stability operations

• Provide the technical requirements in a Master Stability Protocol, review and approve study specific protocols and /or batch enrollment forms 

• Responsible for the handling of annual commercial stability program for assigned products in coordination with sample management groups.

• Authors stability sections of CTD dossiers for post-approval filings, annual reports, product renewals, Annual Product Stability Reviews, and stability related responses to health authority inquiries.

• Serves as stability representative for OOT/OOS investigations, Market Action Fact Finding, and other investigations related to potential quality issues and/or deviations from standards.

• Leads work activities involving Change Controls and CAPA’s .

• Identify information regarding stability program that may impact lab capacity, product studies or regulatory commitments directly.

• Responsible for stability procedures and ensures consistency with site department and BMS groups procedures.

• Participate and/or lead OpEx initiatives to streamline and standardize management of stability programs

• Support health authorities inspection internal and external.

• Represents department in cross functional projects

Education /Experience:

• BS Chemistry Biology or relevant discipline

• 8 years experience of relevant work in a pharmaceutical environment is preferred

Required Knowledge /skills:

• Expert knowledge and understanding of stability ICH Guidelines (Q1A, Q5C) and associated policies, directives and guidance documents. A thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to stability programs in a pharmaceutical manufacturing facility.

• Expert Knowledge of US/EU/ROW Requirements, Corporate Directives and industry best practices.

• Knowledge of Drug Substance and Drug Product manufacturing OSD and good understanding of analytical and/or Microbiology methods.
• Very good skills to drive development of technical or scientific initiatives for solving complex problems/issues; recommending and drive science-based decisions/ implementation of solutions.
• Experience with authorship and able to critically review investigations, interpret results, and generate technical conclusions consistent with Quality management principles
• Good Knowledge of evaluation and interpretation of stability data using statistics software. Review data and demonstrated ability to recognize anomalous trends or results

• Significant experience on health authorities inspections on stability programs.

• Excellent solution oriented, problem solving, decision making skills.

• Exhibit strong leadership, advanced ability to work independently and collaboratively in a team matrix environment, contribute to a team based environment, promoting a high commitment to business goals and objectives.

• Advanced ability to prioritize objectives from multiple projects and ability to adapt to quick changes in schedules in order to accommodate priority requests.

• Excellent written and verbal communication skills, advance knowledge in English and French.

• Advanced knowledge of Microsoft office applications , LIMS, Quality Management system (e.g. Veeva), Statistics software (e.g. SlimSTAT, JMP).

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

The Senior Manager for Asset Management Systems contributes to the effective delivery of IT capabilities and services supporting the asset management functions. You will collaboratively partner with colleagues to understand their information technology and digital enablement needs. You will collaborate with business units and/or functional groups to gather business requirements and be responsible for turning these business requirements into delivered technical solutions.  The role supports the execution of Computer Systems Validation processes.

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 an exceptional 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

• Collaborate with business representatives to understand business needs, challenges and opportunities and how digital capabilities can be leveraged to deliver value.  Translate those needs to business requirements.
• Identify and articulate use cases for proper utilization of software
• Perform demos, process modeling, interviewing, prototyping, and root cause analysis. 
• Analyze data to inform business decisions, and find technological solutions aligning to business needs.
• Develop understanding of BMS policies and procedures related to computer system validation and IT compliance.
• Understand key processes within asset management and understand the value they provide.
• Transform business requirements into functional requirements.
• Transform requirements into digital solutions.
• Collaborate with business stakeholders and implementation partner(s) to configure, build, and deploy Maximo Application Suite and related systems.
• Perform validation activities of Maximo applications.  Generate computer system validation documents (such as plans, reports, protocols, and test scripts) and guide personnel in development/execution of such documents.  Conduct risk & impact assessment to determine the extent of testing.
• Assist groups with data integrity analysis and assessment exercises.
• Support daily operation and future enhancements as a functional and technical expert.
• Support integration initiatives between enterprise systems, e.g. LES, ERP, MES, etc.
• Support multiple IT projects and ongoing work activities of moderate to high complexity.
• Manage small to medium sized IT projects.

Qualifications & Experience

• Functional and technical experience with the following systems (required): IBM Maximo Asset Management 7.6x, Maximo Application Suite and Application Lifecycle Management.  5+ years of experience working with a Maximo application (required), preferably Maximo Application Suite.
• Proficient functional and technical knowledge of Maximo.  
• Experience with use of Maximo in the life sciences industry (desirable).
• General knowledge of other asset management systems (desirable).
• Detailed understanding of end-to-end process flows within the asset management domain.
• Demonstrated technical knowledge and ability to express complex technical concepts in terms that are understandable to the business.
• Demonstrated success as a business analyst working with stakeholders in a GMP environment.
• Demonstrated success using structured problem solving and available tools to quickly evaluate problems, identify root causes, assess impact and develop resolution options.
• Demonstrated success in delivering and supporting COTS, custom-built solutions and partnering with software vendors and service providers.
• Experience working in large and/or complex IT programs, preferably within a regulated industry or biopharma company.
• Extensive knowledge of computer system validation processes.
• Knowledge of cGxP and 21CFR Part11 standards.
• Experience utilizing quality principles and quality assurance methodologies.
• Excellent oral and written communication skills including the ability to write documentation and deliver clear and articulate presentations is required.  Explains own work clearly and confidently.
• Understanding of Information Technology and Software concepts and how these relate to compliance, quality, and data integrity.
• Ability to manage multiple priorities.
• Candidate must have a good level of attention to detail while maintaining a view of the “big picture”.
• Demonstrates openness to learning and developing. Takes a responsibility for their own development and growth.
• 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 6-8 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. ​
• Identifies opportunities to improve and grow, balancing performance feedback and career development.​ 
• 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.​

#LI-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.

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.

This position plays a critical role in ensuring the clinical differentiation of BMS’ Oncology Early Assets across the oncology portfolio. Development and execution of medical differentiation plans is executed across 4 domains. 1.) Insight gathering and integration, 2.) Evidence generation, 3.) Medical Communications, 4.) Patient Journey. This leader owns the EA strategy, including medical evidence generation plans, development of scientific narrative & creation of the integrated evidence plans to advance asset development. This position includes the following responsibilities:

• Develop and execute of medical differentiation plans for assigned compounds across 4 domains. 1.) Insight gathering and integration, 2.) Evidence generation, 3.) Medical Communications, 4.) Patient Journey.

• Be an indispensable partner to Early Asset Development Program Leads, Clinical Development Leads, Tumor Medical/ commercial teams, Translational Medicine to ensure medical readiness, and to deliver against objectives and program milestones, as a core member of the early GPTs.

• Serve as a primary source of medical accountability for a set of early assets; matrix management responsibilities across the internal network (commercial, R&D, medical & access)

• Ensure the development of a clearly differentiated TPP for each early asset.

• Own the Integrated Evidence Plans (IEP) to compliment data generation with Early Drug Development & ongoing evaluation of IST/ITT/strategic collaboration proposals, including medical biomarker and TM components.

• Develop innovative Early Asset internal and external medical education presentations, programs and training.

• Partner with external Thought Leaders (on ongoing basis) to gain medical advice on Early Asset compound strategies, with a goal to inform asset decision making and portfolio tradeoffs.

• Serve as WWM point of contact on various TM workstreams (above asset / asset-agnostic)

• Be the voice of medical to inform and accelerate decision making and governance for assigned compounds.

• Support asset / study level objectives (protocol development, study start-up, enrollment & engagement)

• Work with publications and colleagues from across the business to develop and execute a robust publication strategy.

• Partner with the Translational Medicine & Diagnostic and Commercial organization(s) on Precision Medicine Strategy for Oncology & Hematology

• Exercise enterprise mindset with ability to work in highly matrixed environment.

• Be a science-driven medical affairs professional with high business acumen.

• Advanced degree (MD, PharmD, PhD)

• 8-10 years Clinical, Medical or industry experience

• A breadth of relevant industry experience (Discovery, Medical Affairs or Clinical Development, Commercial). 

• Candidate should ideally have experience developing medical plans / ISR/IST strategy

• Candidate should ideally have therapeutic experience in oncology and/or malignant hematology

• Candidate should ideally have experience interfacing & influencing executive leadership

• Candidate should ideally have experience interfacing with translational medicine /diagnostic organization

• Experience in a customer-facing role with thought leaders and key customers in the early clinical space preferred

• 50% Flexible Work Arrangement onsite in NJ (Princeton Pike, Giralda Farms or Summit)

#LI-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.

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.

This position plays a critical role in ensuring the clinical differentiation of BMS’ Oncology Early Assets across the oncology portfolio. Development and execution of medical differentiation plans is executed across 4 domains. 1.) Insight gathering and integration, 2.) Evidence generation, 3.) Medical Communications, 4.) Patient Journey. This leader owns the EA strategy, including medical evidence generation plans, development of scientific narrative & creation of the integrated evidence plans to advance asset development. This position includes the following responsibilities:

• Develop and execute of medical differentiation plans for assigned compounds across 4 domains. 1.) Insight gathering and integration, 2.) Evidence generation, 3.) Medical Communications, 4.) Patient Journey.

• Be an indispensable partner to Early Asset Development Program Leads, Clinical Development Leads, Tumor Medical/ commercial teams, Translational Medicine to ensure medical readiness, and to deliver against objectives and program milestones, as a core member of the early GPTs.

• Serve as a primary source of medical accountability for a set of early assets; matrix management responsibilities across the internal network (commercial, R&D, medical & access)

• Ensure the development of a clearly differentiated TPP for each early asset.

• Own the Integrated Evidence Plans (IEP) to compliment data generation with Early Drug Development & ongoing evaluation of IST/ITT/strategic collaboration proposals, including medical biomarker and TM components.

• Develop innovative Early Asset internal and external medical education presentations, programs and training.

• Partner with external Thought Leaders (on ongoing basis) to gain medical advice on Early Asset compound strategies, with a goal to inform asset decision making and portfolio tradeoffs.

• Serve as WWM point of contact on various TM workstreams (above asset / asset-agnostic)

• Be the voice of medical to inform and accelerate decision making and governance for assigned compounds.

• Support asset / study level objectives (protocol development, study start-up, enrollment & engagement)

• Work with publications and colleagues from across the business to develop and execute a robust publication strategy.

• Partner with the Translational Medicine & Diagnostic and Commercial organization(s) on Precision Medicine Strategy for Oncology & Hematology

• Exercise enterprise mindset with ability to work in highly matrixed environment.

• Be a science-driven medical affairs professional with high business acumen.

• Advanced degree (MD, PharmD, PhD)

• 8-10 years Clinical, Medical or industry experience

• A breadth of relevant industry experience (Discovery, Medical Affairs or Clinical Development, Commercial). 

• Candidate should ideally have experience developing medical plans / ISR/IST strategy

• Candidate should ideally have therapeutic experience in oncology and/or malignant hematology

• Candidate should ideally have experience interfacing & influencing executive leadership

• Candidate should ideally have experience interfacing with translational medicine /diagnostic organization

• Experience in a customer-facing role with thought leaders and key customers in the early clinical space preferred

• 50% Flexible Work Arrangement onsite in NJ (Princeton Pike, Giralda Farms or Summit)

#LI-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.

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 Associate Director of Biostatistics is a member of cross-functional Development teams and contributes to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions. With appropriate experience, the Associate Director of Biostatistics can have responsibilities for providing statistical leadership for a particular indication of an asset. These individuals develop collaborative relationships and work effectively with the Biostatistics therapeutic area Lead and other cross functional team members.

• Collaborates in design of innovative and efficient clinical trials, including the selection of study population/endpoints to address study objectives, and contributes to project development strategy
• Defends protocols and analysis plans at internal governance reviews and provides independent reviews of complex protocols.
• Independently authors and/or reviews protocol, statistical analysis plan, clinical study reports, associated publications, and other study level documents
• Presents summary data and analyses results, in a clear, concise, complete, and transparent manner
• Provides statistical support and leadership to address health authority request, publication, presentation, and other public release of information
• Manages multiple studies to ensure consistency and adherence to standards within an indication or therapeutic area
• Applies extensive knowledge of statistical / clinical trials methodology as it relates to clinical development
• Invests in developing knowledge outside of traditional statistical expertise in the clinical, regulatory and commercial environments with demonstrated application to study design
• Effectively engages as a matrix team member on project teams, to act as a scientific and strategic partner in the drug development process
• Compliant with BMS processes and SOPs, adherence to global and project standards within an indication or therapeutic area and responsible for quality of deliverable
• Contributes to external and internal statistical community of practice
• Develops & advises team members
• 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

• PhD (6+ years’ experience) or MS (8+ 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, data manipulation, graphing & simulation
• Great interpersonal, communication, writing and organizational skills
• Expertise in statistical/clinical trials methodology as it related to clinical development and ability to apply to relevant clinical development framework
• Good understanding of regulatory landscape and experience with participating in regulatory interactions
• Demonstrate collaboration, organizational/leadership abilities, and interpersonal skills
• Demonstrate ability to plan, organize, and prioritize multiple work assignments, and strong project management 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.

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.

Summary:

The primary role of the Medical Science Liaison (MSL) is to engage in meaningful peer-to-peer scientific dialogue with healthcare system leaders such as Regional Thought Leaders (RTLs), National Thought Leaders, and Healthcare Professional (HCPs) within a defined geography to translate science into patient care. MSLs will also engage the top HCPs in high-disease burden hospitals.

The MSL will engage in educational dialogue with relevant HCPs and share relevant clinical evidence and information based on the physicians’ needs and in accordance with the field medical plan. The MSL will also be responsible for serving on a scheduled, standing basis as “Medical on Call” - virtually engaging treating physicians in the community, facilitated by their commercial counterpart, TAS (Therapeutic Area Specialist), to answer unsolicited off-label and technically complex questions in real time. The Medical on Call capability and operating model will be implemented in 2024/5 on a market-by-market basis as the technology and operating model are ready.

This role is field-based, and it is anticipated that the employee will spend a majority of the time in the field interacting with external stakeholders, including investigators and clinical thought leaders, while also supporting internal stakeholders and continuing to maintain a high level of therapeutic expertise.

The territory this role will support includes: Kentucky, West Virginia and Virginia

Responsibilities:

Develops trusted relationships with appropriate academic and community Thought Leaders (TLs) in Oncology through high-quality peer-to-peer scientific dialogue in both proactive and reactive settings. The MSL will use various channels for interactions (1:1, group presentations, virtual, etc.)

Medical engagement

• Effectively collaborates and engages in scientific dialogue with TLs to gain insights on clinical landscape to ensure development of a medical plan that is both product/disease area focused and translates into effective launch
• Proactively engages in scientific and clinical conversation to ensure development of a medical plan that is both product/disease area focused and translates into effective launch and LCM activities.
• Engages with medical societies, PAGs (Patient Advocacy Groups) and guideline committee members as appropriate.
• Provides training for external speakers as needed.
• Strategically engages payers in the pre- and peri-launch phases (with fHEOR and Account Executives).
• Provides medical support to address unsolicited HCP questions in real-time, both in face-to-face interactions and through the Medical on Call virtual capability.
• Develops credible connections with key Thought Leaders (TLs) in Oncology through high-quality peer-to-peer scientific dialogue.
• Appropriately document and achieve annual goals 
• Leverages digital capabilities to enhance medical engagement

Clinical Trial engagement

• Provides recommendations and insights to clinical development team on study feasibilities within the therapeutic area based on knowledge of the field and through direct contacts with potential investigators, as agreed with home office medical and GDO.
• Liaises with key large accounts to understand clinical barriers to patient access and ensuring equity in access to clinical trials.
• Leads major evidence read-outs with clinical trial investigators e.g., Ph 3 top-line data.
• Support Interventional and Non-Interventional Research (NIR) studies (e.g. identification and assessment of potential study sites) to facilitate patient recruitment and/or discussions around the safe and effective use of BMS investigational products, as agreed with home office medical and Global Development Operations (GDO) and as defined by the study scope document
• Provide recommendations and insights to clinical development team on study and site feasibilities within the therapeutic area based on knowledge of the field and through direct contacts with potential investigators, as agreed with home office medical and GDO
• Support HCPs in the ISR submission and execution process and study follow-up as agreed upon with home office medical and GDO
• Ensure that BMS Pharmacovigilance procedural documents are understood and applied by investigators of local studies, and alert appropriate BMS personnel to any identified Adverse Events
• If applicable, support CRO sponsored studies as agreed with home office medical and GDO and as defined by the study scope document

Required Qualifications & Experience:

• MD, PharmD, PhD, APP, PA, NP with experience in a specific Disease Area or with a broad medical background or relevant pharmaceutical experience
• Working in a scientific and/or clinical research environment. Field medical expertise preferred.
• Deep understanding of TL environment and needs.

Strong Oncology experience

• Scientific or clinical disease area knowledge, patient treatment trends, clinical landscape
• Pharmaceutical industry including compliance and regulatory guidelines

Understanding of scientific publications

• Clinical trial design and process
• Understanding of national and regional healthcare and access environment.

Travel

• As this position requires the operation of a Company-provided vehicle, offers of employment are contingent upon the candidate meeting the requirements of “Qualified Driver,” as determined by the Company in its sole discretion, including but not limited to the following: 1) at least 21 years of age; 2) a driver’s license in good standing issued by your state of residence; and, 3) a driving risk level deemed acceptable by the Company.
• The MSL will spend majority of their time in the field with their external customers and additional requirements based on territory assignment and team needs, as needed.

Key competencies desired:

Scientific Agility

• - Ability to engage in a dialogue about data in a compelling, fair and balanced way and explain in a manner that resonates with TLs/HCPs
• - Expert knowledge of clinical practice and evolving healthcare delivery models.
• - Ability to understand and critically appraise scientific publications.
• - Knowledge of clinical trial design and methodology, including Good Clinical Practices and ethical, governmental, and regulatory requirements.
• - Understands treatment paradigms, competitive landscape and can frame information in a convincing and compliant way that resonates with physicians.
• - Excellent communication and presentation skills to articulate scientific and clinical data in an easy-to-understand manner to help HCPs best serve their patients.
• - Has a strong learning mindset and passion for science. Prioritizes staying current with the latest data.

Patient centricity

• Understands the patient journey and experience.
• Has a patient-focused mindset.

Customer-focused/enterprise mindset

• Understands overall enterprise objectives and prioritization.
• Winning Mindset: results-oriented, positive, resilient attitude, able to quickly adapt in an ever-changing environment.
• Willingness to embrace new ways of working and technological tools.
• Demonstrated ability to drive organizational performance.
• Experience identifying, engaging, and cultivating relationships with HCPs.
• Demonstrated ability to influence matrix organization and problem-solving mentality.

Analytical Capability

• Ability to analyze data, such as market trends, and HCP preferences. Data-driven insights help them strategize and target their efforts effectively.
• Ability to segment HCPs based on their preferences and other relevant factors. This helps them tailor their communication and proactive presentations to suit individual HCP needs.
• Ability to derive actionable insights from data and analytics, including CE^3 analytics engine.
• Providing feedback proactively to enable continuous improvement of technology and tools like CE^3.

Technological Agility

• Understanding, adapting, and effectively using technology in various aspects of healthcare business and interacting with HCPs.
• Utilizing various digital communication channels such as emails, instant messaging apps, and video conferencing to stay in touch with healthcare professionals, colleagues, and clients. This enables them to respond promptly to inquiries, share updates, and maintain effective communication.
• Competency using CE^3 and other software or CRM tools to collect, enter, and manage quality HCP data in a timely manner, track interactions, and plan future engagements with healthcare professionals
• Ability to use the Medical on Call technology effectively.
• Keeping up to date with technological advancements and changes.

Teamwork/Cross-functional mindset

• Ability to work independently and act as a team player by developing strong rapport and working relationships with external and internal stakeholders.
• Knowledge of the national healthcare and access environments.
• Deep knowledge and experience of RWE. Ability to interpret RWE and identify opportunities for RWE projects.
• Be a representative of BMS in all interactions with external stakeholders.
• Holds a high level of integrity and good judgment, to navigate the requirements of the role effectively and compliantly in accordance with BMS policies and procedures.

The starting compensation for this job is a range from $150,000 - $200,000, plus incentive cash and stock opportunities (based on eligibility).  The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.  Final, individual compensation will be decided based on demonstrated experience.  Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Careers site. 

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. 

#LI-Remote

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.