Job Search Results
Medical and Regulatory Affairs
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, 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.
Senior Manager, Operational Excellence – GRSP Business Operations
Summary
The Business Operations Group Lead will be jointly responsible for driving key projects to support operational excellence activities for Global Regulatory Strategy & Policy and providing managerial support for other Global Regulatory Managers (GRMs)
- Operational Excellence:
- Drives operational excellence initiatives across GRSP and with cross-functional stakeholders
- Assesses and develop plans to streamline processes and ways of working to remove duplications and finds efficiencies/synergies
- Analyzes existing regulatory systems and tools to look for opportunities of improvement.
- Partners with cross-functional stakeholders to develop actionable plans for improving regulatory systems and tools
- Team Member Development:
- Supports the GRM Community of Practice knowledge and sharing learning forums to empower team development and initiatives
- Fosters a strong culture of continuous regulatory improvement and sustainable high standards of performance through training, coaching and stakeholder engagement
- Directs training and onboarding of new hires for evaluation of development progression
- Manages and supports Global Regulatory Managers in the coordination and creation of governance-approved global regulatory plans and transmittal to cross functional SMEs for execution
- Manages and supports regulatory work schedules with for assigned projects using common data points and milestones, annual reports, PMR and PMCs
- Manages, tracks, and reviews regulatory deliverables for each therapeutic area to ensure BOW is equitable across team members
- Stakeholder Management:
- Demonstrates strong communication, interpersonal and negotiating skills and leverages those competencies to ensure continuous progress within both internal and external teams thus moving issues to resolution
- Actively engages with leadership cross functional team members and escalate issues proactively
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Administrative Services
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, 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.
The Early Clinical Development (ECD-HOCT) team at BMS is responsible for hematology, oncology and cell therapy pipeline assets and sits at the interface between discovery and translational science and clinical drug development. Composed of physician-scientists and clinical-scientists, this group oversees the early development of both internal and partnered assets covering all platforms of therapies, including small molecules, traditional and complex biologics and next gen cell therapies. Therapeutic areas span the full range of hematologic and solid tumor indications. The ECD-HOCT team interacts hand-in-glove with discovery and translational scientists, project leadership, late development, commercial colleagues and other key functions to optimize biomarker, patient enrichment, dosing and combination strategies to enable faster and more effective drug development informed by core scientific principals and data.
Position Summary:
We are seeking a highly motivated Executive Assistant to join BMS. The position provides comprehensive administrative support to two leaders: VP, Early Clinical Development Oncogenesis & VP, Early Clinical Development Immuno-Oncology and Cell Therapy within the R&ED organization located in Brisbane, CA. The successful candidate must be detail oriented, have strong organizational and coordination skills, and excellent communication skills. They will have demonstrated ability to prioritize, work independently, and be able to learn new tools and systems in an ever-evolving environment. The successful candidate will be highly collaborative and comfortable working in a fast-paced, team-oriented environment.
Responsibilities (include, but are not limited to):
Perform highly diverse and complex administrative functions, including but not limited to proactive calendar management, travel arrangements, ensuring manager’s meeting preparedness (e.g., assemble meeting materials & pre-reads) & preparing expense reports
Demonstrate strong interpersonal skills and diplomacy in all levels of management.
Work with minimal supervision, have strong initiative and follow-up with focus on details
Phone and calendar management as well as timely scheduling to ensure meetings are prioritized and occur within appropriate timelines.
Support specific operations through scheduling Town Halls, site, and department level event planning, etc.
Organize meetings and events including scheduling, coordinating room schedules, AV assistance and catering
Provide coordination with other groups, CROs, vendors, equipment, maintenance, service contracts, collaborators etc.
Create purchase orders and assist in reconciling open purchase requisitions
Maintain and organize office operations and procedures such as expense reports, requisition of supplies, and other administration services.
Serve as a key point of contact to help resolve payment/invoicing/ordering issues.
Support various projects as needed for team leads & external collaborations including basic project management.
Welcome new hires to the site but completing i-9 verifications and assisting with any HR tasks including submitting job requisitions.
Partner with other site Executive Assistants as needed
Qualifications:
High School degree, some college, or degree desirable.
Minimum of 8 years of executive level administrative or comparable experience in a scientific research environment. Pharmaceutical, biotech start-ups, and venture capital companies preferred.
Highly proficient with Microsoft Suite (Outlook, Word, Excel, PowerPoint)
Knowledge of the following applications is highly preferred: Concur, Ariba/SAP, SharePoint, Room Scheduler, Workday, Microsoft Teams.
Excellent communication skills
Proven ability to handle Confidential matters
#LI-Hybrid
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Medical and Regulatory Affairs
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, 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.
Head, Scientific Communications & Engagement (SCE)
Position Summary
The Head of Scientific Communications & Engagement (SCE) has a strong scientific communications background, preferably with experience in one of BMS’ major therapeutic areas (Oncology, Hematology, Immunology, Fibrosis, CV), with ability to apply clinical and scientific expertise to drive global internal and external Medical Communications for training and external engagement with HCPs, patients, and payers. S/he will report to the Head of Global Medical organization and lead a team that will own the Scientific Narrative, develop the Scientific Communication Platform (SCP) and associated tactics (i.e. Publications, Scientific Content, Med Info, Med Education, Field Medical training) to ensure pull-through of the Scientific Narrative. S/he will be accountable for disclosure of the science and health economic value of BMS products and research data that informs Healthcare Providers, Patients, and Payers worldwide.
The incumbent has a track record of innovation with a clear vision on how new technologies can be successfully implemented in effective and personalized medical communication. They will apply enterprise mindset and lead strategically across the BMS matrix by working with stakeholders from WW medical and local market medical teams, Research & Early Development (R&ED), Global Drug Development (GDD), Health Economics & Outcomes Research (HEOR), Global Biometric Sciences (GBS), Regulatory, Pharmacovigilance, Corporate Affairs, Competitive Intelligence, Legal, Business Insights & Analytics (BI&A) and other key functions.
S/he will be accountable for aligning with cross-functional stakeholders on highest priority areas, develop the right personalized communication materials, and disseminate through optimized channels to appropriate internal & external stakeholders at the right time. S/he will enable streamlined collaboration with Worldwide Customer Capabilities (WCC) team to drive external engagement planning, digital, and omni-channels. S/he will manage a team of training and compliance specialists to ensure internal readiness of field-based and home office employees for clinical trials, launches, key congresses, and audits. S/he will enable data-driven decision making by partnering with BI&A to effectively leverage external Medical insights and innovative analytics.
Key Responsibilities
- Provide leadership and trusted partnership to the worldwide TA and Market Heads and across the R&D continuum to develop Medical Communication strategy inclusive of creation, packaging, and dissemination of Medical Communications.
- Accountable for delivery of timely and high-quality medical publications, scientific content, and congress presentations worldwide in alignment with overall Medical vision, strategy, and objectives.
- Provide scientific communication leadership through story-telling that translates BMS science into patient care and enables internal readiness for external engagement.
- Must have strong business acumen, ability to interface with senior leaders to make trade-off decisions and navigate through budget/resource constraints to deliver on business priorities.
- Provide strategic direction for developing personalized scientific communications through landscape analysis and insights that meets the needs of HCPs, payers, and patients.
- Proven change leader who demonstrates forward thinking, proactive, strategic, and collaborative approach.
- Lead with business savviness and innovative mindset and approaches to data analytics to define value drivers that will drive data-driven decisions.
- Leverage personal & non-personal channels (social media) and social media listening to broaden reach of our scientific communications.
- Accountable for Medical Communications OpEx budget and allocation of funds to TA-specific Medical Communications and ensure resource allocation to highest business priorities.
- Lead Global Medical training and drive compliance with GxP, evolving landscape, technology, and third-party oversight.
- The incumbent maintains clinical, scientific, and technical expertise in specific therapeutic areas; reviews scientific journals; attend scientific and key technical meetings; network with external professional associations (i.e. MAPS, PhactMI, MILE, ISMPP), and participate in internal training programs. Keeps abreast of the current literature, collects and communicates medical and scientific insights and intelligence relevant to lifecycle and product portfolio.
Key Capabilities for Role
Innovation
- Leadership behaviors for innovation to help define the unmet need and spark partner collaboration in innovation
- Evolve ‘where we play’ to build effective presence in geographies of intense innovation
- Leverage partner capabilities for innovation to unlock the maximum value from innovation
- Competitively pivots to improve quality and speed of decision making to advance the right ideas
- Accelerate digital capability by using technology and analytics to increase value, engagement, agility and decision making
- Analyze and disrupt the status quo and develop advanced analytics to drive competitiveness, inform our decisions and innovate the way we operate
- Innovative leadership to accelerate digital capabilities and investments in data and IT systems, social media, and patient engagement
Leadership
- Strong capacity to work, collaborate, communicate, influence, and lead in a cross-functional matrix environment, delivering on Medical strategies with a one-team, one-portfolio mindset
- Excellent executive presentation skills, ability to communicate complex ideas clearly and concisely, and to influence others to think through problems, improvement opportunities, solutions, and plans
- Motivate, inspire and influence others across the organization and enterprise to achieve results and adopt new operational models.
- Outstanding visionary that strategically leads the development and maturity of technical and business capabilities.
- Demonstrated leadership capability including the ability to lead and manage through change
Talent
- Demonstrated track record as a Talent Champion in coaching, developing, retaining, acquiring, and building a diverse pipeline of future talent
- Gather internal and external data & insights to advance inclusive culture
- Revitalized focus on building a best-in-class innovation culture
- Ignite our impact and challenge status quo, push boundaries, organize key stakeholders across the business and HR, to optimize and deliver for Medical
- Develop and execute regional strategies to increase cultural competency and meet local market needs
- Shape/provide thought leadership to drive differentiated outcomes
Business Acumen
- Cost engineering for innovation drives to drive value captured through efficiency projects
- Has a strong understanding of external environment and pivots to stay ahead of competition
- Match core partner capabilities to unmet needs for innovation
- Ability to synthesize rapidly evolving healthcare dynamics and translate to new business/organizational models
- Optimize functional efficiency and streamline systems and processes to optimize the MCDC portfolio
- Unlocking incremental value through our strategic internal and external partnership by applying tools and best practices to influence the way we work
Change Management
- Lead the strategy and execution of change management processes and tools to build a strategy that support the adoption of changes required by global projects and initiatives to be deployed across SCE.
- Identify, mitigate and manage anticipated resistance, issues, and risks, proactively.
- Integrate change management activities into SCE project and program plans, according to SCE strategy and Therapeutic Area Medical Plans.
- Identify measures of successful adoption, utilization, proficiency, and change risk mitigation in consultation with key business partners.
- Develop and maintain key stakeholder relationships, ensuring the business leadership team is aligned and a true sponsor of change(s).
Technical Skills
- Advanced scientific required (MD, PharmD, PhD).
- Training and scientific expertise in one of BMS’ major therapeutic areas (Oncology, Hematology, Immunology, Fibrosis, CV).
- Develops and maintains strong network with Thought Leaders and scientific societies, a credible voice of Medical with external customers.
- Ability to connect the “internal” science to the “external” unmet medical need.
- Ability to communicate complex clinical data in a user-friendly way.
- Experience in leveraging Real World Evidence to inform treatment guidelines and patient access.
- Functional understanding of Drug Development and implementation of Medical strategies.
Qualifications & Experience
- Minimum of 15+ years of mix of development/clinical and medical experience, with an emphasis on Global or Market based Medical Affairs experience.
- Credible, dynamic leader and capable of interacting across all levels of the business with a demonstrated track record of establishing and actively managing relationships with key external stakeholders, matrix partners, and other company resources to optimize capabilities.
- Clinical or Academic Experience (Patient Facing) is desirable.
- Advanced leadership skills/experience managing people and portfolio understanding of Research and Drug Development and the ability to communicate data in an impactful way.
- Acts with the highest level of integrity, flexibility, and credibility at customer/stakeholder interface.
- Proven experience in building new organization/capabilities and high-performing teams.
- Proven track record developing effective strategic directions and communications that drive results.
- Demonstrated strong and proven communication, people management, and stakeholder management skills.
- Strong matrix leadership management, enterprise mindset, and adaptability to change.
- Experience leading global/virtual teams with a strong understanding across a range of medical, commercial and R&D roles.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Qlty Assurance Methods
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, 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.
Cell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today. With therapies only in their infancy and BMS’s continued investment in our Cell Therapy capabilities, the growth potential of this science, your career, and the ability to help patients are incredible.
PURPOSE AND SCOPE OF POSITION:
This role is responsible for the day-to-day operations of the Field Quality Assurance (QA) team at the Devens, MA Cell Therapy Manufacturing site. The Field QA team is responsible for 24x7 oversight of the operations at the Devens site, including but not limited to Manufacturing, Quality Control laboratories, and Warehouse Operations.
This person will be a key leader in the Quality Assurance management team and a champion for quality principles and compliance within the Quality organization. This position reports directly to the Director of Cell Therapy Quality Assurance for the Devens site.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
Expertise in GMP compliance and FDA/EMA regulations
Experience with implementing and overseeing GMP operations in a plant manufacturing commercial products
Background in Protein Biologics or Cell Therapy Manufacturing is desired
Demonstrated experience building and leading exceptional teams is required
Demonstrated excellence in written and verbal communication
Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships
Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a senior management team member and to engage and influence team members in a matrixed environment
DUTIES AND RESPONSIBILITIES
Responsible for the Quality Assurance oversight of GMP operations at the Devens Manufacturing site and ensuring adherence to applicable GMP regulations and BMS policies and procedures
Provide direction and ensure timely guidance to Field QA personnel during handling and resolution of GMP events (deviations, non-conformances and corrective action assessments)
Develop a comprehensive understanding of the manufacturing processes followed for BMS products and the associated risk management control strategy developed to identify process risks and associated critical controls around the associate processing steps.
Collaborate with stakeholders and management, and effectively communicate status
Ensure timely Quality support to site compliance activities such as Change Control impact assessments, deviation impact assessments, and development of corresponding CAPAs
Collaborate with other leaders across the organization and assist in the continuous improvement and lifecycle management of implemented GMP policies and quality management system
Contribute to the development and execution of BMS Inspection readiness plan at the Devens Manufacturing site
Develop departmental goals and ensure the timely completion of all deliverables, including batch record review
Champion and foster a positive and successful quality culture, aligned with BMS’s existing culture
Mentor Quality personnel and enable their individual growth
Act as subject matter expert for QA oversight of GMP operations during audits and regulatory inspections.
EDUCATION AND EXPERIENCE
BS/MS in relevant Science or Engineering discipline and 9+ years of experience in within a GMP Quality Assurance function (or equivalent experience) with a minimum of 7 years of people management experience
WORKING CONDITIONS: PHYSICAL /MENTAL DEMANDS:
Able to stand and walk for several hours at a time to provide on-the-floor leadership and GMP walkthroughs
Able to move between rooms in a timely manner.
Able to gown for ISO 8 and ISO 7 rooms (medical scrubs, safety shoes, safety glasses, gloves, coveralls, booties, etc.).
If you want to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients’ lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
#BMSCART, #VETERAN, #LI-Onsite
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Medical and Regulatory Affairs
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, 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.
Head, Medical Evidence Generation (MEG)
Position Summary
The Head of Medical Evidence Generation is a trained and scientific expert in one of BMS’ major therapeutic areas (Oncology, Hematology, Immunology, Fibrosis, CV) with ability to apply clinical and scientific expertise across multiple therapeutic areas. S/he has an interest in innovative scientific evidence generation, and will report to the Head of Global Medical organization and lead a team of worldwide therapeutic area evidence leads, clinical trial physicians, clinical trial leads, clinical scientists, and external engagement leads, responsible for all internal and external Medical Evidence Generation across all BMS therapeutic areas and Markets.
The Head of Medical Evidence Generation in partnership with the worldwide therapeutic area (TA) teams will define and manage the Integrated Evidence Plan (IEP) and ensure all MEG conducted through various modalities is aligned with IEPs. S/he is accountable for MEG portfolio management, execution, and performance metrics for Investigator Sponsored Research (ISR), BMS-sponsored late phase trials (i.e. Phase IV, non-interventional, and other post-marketing trials) and collaborative research studies to drive innovative research.
The incumbent will apply enterprise mindset and lead strategically across the BMS matrix by working with stakeholders from WW medical and local market medical teams, Research & Early Development (R&ED), Global Drug Development (GDD), Health Economics & Outcomes Research (HEOR), Global Biometric Sciences (GBS), Regulatory, Pharmacovigilance and other key functions to align on highest priority areas and data gaps, review of proposals, and execution of approved studies and collaboration agreements. The incumbent will focus on building research collaborations across R&ED, GDD, Medical, HEOR, and external partners such as academic and key research centers, community networks, professional societies, and cooperative groups in order to accelerate BMS research. S/he is responsible for leading this global capability, ensuring the development, internal alignment, and execution of the strategies across key research accounts.
Key Responsibilities
- Provide leadership and trusted partnership across internal matrix and external collaborative partners that will drive MEG strategy and execution.
- Partner with worldwide TA and Market Heads to develop 3-year MEG portfolio plan and advise Medical, R&ED, and GDD leadership to evaluate, design, and enhance long- and short-term strategies.
- Lead a global portfolio capability and governance structure for MEG to inform MEG strategy, optimize portfolio, drive execution, and ensure timely delivery of data to fill gaps identified in IEPs in collaboration with cross-functional stakeholders.
- Foster an innovative culture and lead initiatives to increase innovative approaches to evidence generation.
- Must have strong business acumen, ability to interface with senior leaders to make trade-off decisions and navigate through budget/resource constraints to deliver on business priorities.
- Establish enterprise strategy for external strategic collaborations across BMS functional areas to provide aligned direction leveraging external expertise that will advance BMS portfolio through innovative research.
- Lead with business savviness and innovative approaches to data analytics to define value drivers that will drive data-driven decisions.
- In partnership with Finance, BI&A, and WW TA Leads to establish automated reporting and distribution of budget and tracking of financial health of MEG portfolio.
- Manage a team of Executive Directors in each therapeutic area responsible for the MEG portfolio and a VP of strategic collaborations.
The incumbent maintains clinical, scientific, and technical expertise in specific therapeutic areas; reviews scientific journals; attend scientific and key technical meetings; and participate in internal training programs. Keeps abreast of the current literature, collects and communicates medical and scientific insights and intelligence relevant to lifecycle and product portfolio.
Key Capabilities
Innovation
- Leadership behaviors for innovation to help define the unmet need and spark partner collaboration in innovation
- Evolve ‘where we play’ to build effective presence in geographies of intense innovation
- Leverage partner capabilities for innovation to unlock the maximum value from innovation
- Competitively pivots to improve quality and speed of decision making to advance the right ideas
- Accelerate digital capability by using technology and analytics to increase value, engagement, agility and decision making
- Analyze and disrupt the status quo and develop advanced analytics to drive competitiveness, inform our decisions and innovate the way we operate
- Innovative leadership to accelerate digital capabilities and investments in data and IT systems, social media, and patient engagement
Leadership
- Strong capacity to work, collaborate, communicate, influence, and lead in a cross-functional matrix environment, delivering on Medical strategies with a one-team, one-portfolio mindset
- Excellent executive presentation skills, ability to communicate complex ideas clearly and concisely, and to influence others to think through problems, improvement opportunities, solutions, and plans
- Motivate, inspire and influence others across the organization and enterprise to achieve results and adopt new operational models.
- Outstanding visionary that strategically leads the development and maturity of technical and business capabilities.
- Demonstrated leadership capability including the ability to lead and manage through change
Talent
- Demonstrated track record as a Talent Champion in coaching, developing, retaining, acquiring, and building a diverse pipeline of future talent
- Gather internal and external data & insights to advance inclusive culture
- Revitalized focus on building a best-in-class innovation culture
- Ignite our impact and challenge status quo, push boundaries, organize key stakeholders across the business and HR, to optimize and deliver for Medical
- Develop and execute regional strategies to increase cultural competency and meet local market needs
- Shape/provide thought leadership to drive differentiated outcomes
Business Acumen
- Cost engineering for innovation drives to drive value captured through efficiency projects
- Has a strong understanding of external environment and pivots to stay ahead of competition
- Match core partner capabilities to unmet needs for innovation
- Ability to synthesize rapidly evolving healthcare dynamics and translate to new business/organizational models
- Optimize functional efficiency and streamline systems and processes to optimize the MCDC portfolio
- Unlocking incremental value through our strategic internal and external partnership by applying tools and best practices to influence the way we work
Change Management
- Lead the strategy and execution of change management processes and tools to build a strategy that support the adoption of changes required by global projects and initiatives to be deployed in MEG and across Medical.
- Identify, mitigate and manage anticipated resistance, issues, and risks, proactively.
- Integrate change management activities into MEG project and program plans, according to MEG strategy and Therapeutic Area Medical Plans.
- Identify measures of successful adoption, utilization, proficiency, and change risk mitigation in consultation with key business partners.
- Develop and maintain key stakeholder relationships, ensuring the business leadership team is aligned and a true sponsor of change(s).
Technical Skills
- Training and scientific expertise in one of BMS’ major therapeutic areas (Oncology, Hematology, Immunology, Fibrosis, CV).
- Develops and maintains strong network with Thought Leaders and scientific societies, a credible voice of Medical with external customers.
- Ability to connect the “internal” science to the “external” unmet medical need.
- Ability to communicate complex clinical data in a user-friendly way.
- Ability to leverage real-world evidence in patient outcome.
- Hands on experience in designing and executing clinical trials.
- Functional understanding of Drug Development and implementation of Medical strategies.
Qualifications & Experience
- Advanced scientific degree. MD preferred.
- Minimum of 15+ years of mix of development/clinical and medical experience, with an emphasis on Global or Market based Medical Affairs & Clinical trial conduct/execution experience.
- Credible, dynamic leader and capable of interacting across all levels of the business with a demonstrated track record of establishing and actively managing relationships with key external stakeholders, matrix partners, and other company resources to optimize capabilities.
- Clinical or Academic Experience (Patient Facing) is desirable.
- Significant experience with collaborative projects, thought leader engagement, and negotiation.
- Advanced leadership skills/experience managing people and portfolio understanding of Research and Drug Development and the ability to communicate data in an impactful way.
- Acts with the highest level of integrity, flexibility, and credibility at customer/stakeholder interface.
- Proven experience in building new organization/capabilities and high-performing teams.
- Proven track record developing effective strategic governance and communications that drive results.
- Effective communication, people management, and stakeholder management skills.
- Strong matrix leadership management, enterprise mindset, and adaptability to change.
- Experience leading global/virtual teams with a strong understanding across a range of medical, commercial and R&D roles.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Information Management
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, 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.
Summary:
The Cell Therapy Global Manufacturing Data Analytics Lead (Assoc. Director IT) role is instrumental in partnering with Cell Therapy Manufacturing Site IT and Business Leadership in defining data analytics strategy and roadmap for the Cell Therapy Manufacturing Network.
This leader provides the vision and day-to-day management necessary to establish analytics program for the CT global manufacturing network supporting the commercial manufacturing sites.
This position partners with global IT stakeholders, BI&A, site IT leads and various business stakeholders in the Cell Therapy Manufacturing Network and is accountable for creating site analytics strategy, creation of roadmaps, leading the governance for prioritization and intake of work in support of these capabilities. This role will partner with business to advance our site analytics strategy in support of manufacturing objectives that can have the highest business impact and be accountable for its deployment and business value realization outcomes.
This role will report to the Sr. Director, IT Business Partner for Cell Therapy Global Manufacturing and will also be part of the Cell Therapy Manufacturing IT Leadership Team.
Required Competencies: Knowledge, Skills, and Abilities:
- Ability to effectively communicate with both technical and non-technical team members.
- Ability to manage budgets and build multi-year deployment roadmaps
- Ability to interact with senior business leadership and translate business strategy into executable IT programs.
- Strong interpersonal skills, especially regarding:
- Teamwork and collaboration
- Customer focus
- Verbal and written communication
- Knowledge of industry standard integration protocols and programming applications
- Knowledge and experience with data platforms, enterprise data lake technologies, data integration tools, visualization tools. Knowledge of AWS services that form foundations of data platforms is preferred.
- Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices.
- Strong technical and problem-solving skills and the ability to work independently.
- Demonstrated success working in a high-performing, business results-driven environment.
- Expertise with Business Intelligence (BI) and reporting programs. Tableau experience preferred.
- Understanding of computer system validation.
- Proven experience of establishing data analytics strategy and achieving business outcomes from use of data in manufacturing plants to improve operational excellence.
Education and Experience:
- Bachelor’s degree in an engineering or Science related discipline. Advanced degree (MS) preferred
- Must have 5+ years of experience in data analytics roles with 3+ years of experience in a manufacturing environment (industry agnostic)
- Understanding of supply chain, manufacturing domains, and supporting technology including manufacturing and supply chain ERP systems (e.g., Oracle, SAP) is preferred.
- Working knowledge of regulatory requirements and how they relate to existing and new business systems and practices, primarily GxP.
- Must have prior experience working on a project team to implement, customize, or enhance data warehouse, data lake systems.
- Experience with continuous delivery, dev-ops, open-source technologies & Agile/Lean software development (e.g. Scrum, Kanban, XP).
- Experience building highly scalable, concurrent, large volume, event-driven systems supporting manufacturing.
- Experience with CI / CD tools and configuration management tools is preferred
Duties and Responsibilities:
- Collaborate with business stakeholders and implementation partner(s) to configure, build, and deploy data analytics related solutions in GMP environment.
- Establish strong governance at global manufacturing level to prioritize demand intake, delivery incremental value and drive standardization across the network.
- Owns the governance process for Cell Therapy Manufacturing network around change management of analytics tools.
- Ensure consistent deployment data related platforms across manufacturing network.
- Manages the delivery/enhancements of data ingestion projects, setup of CT Manufacturing related data programs and delivery of analytics/reporting in support of business objectives.
- Own and manage roadmap of data related platforms as they impact CT manufacturing, enhancements, and budgets for deployment of data/analytics tools.
- Design and implement an effective and top in class solution to capture, collate, store and maintain real time data for purpose of achieving operational excellence, measuring progress and performance (though a common database solution as an example) in relation to making of CAR-T products.
- Identify ways to resolve data pain points and maintain data integrity and consistency across functions consuming the same data in pre-production and test environments, Support data problems in test environments
- Ensure data solutions comply with internal and external regulations / standards and monitor data integrity.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, 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.
Reporting to the Head of R&D Global Strategic Change, you will lead the development and delivery of change management strategies and plans for the highest priority initiatives in R&D. Immediate examples include the implementation of our global Strategic Roadmap, our R&D Productivity program, our Innovation Program, post-merger integration opportunities, and other strategic programs.
Key responsibilities include:
- Define and own R&D-wide global change management program for multiple strategic initiatives, while connecting to other ongoing and planned initiatives, to ensure a common and compelling vision for the organization.
- Diagnose the organization’s readiness for large-scale change.
- Provide hands on expertise and develop change strategies through the development of stakeholder analysis, impact assessments, engagement plans, impact assessments, change readiness plans and quantitative success measures that will reinforce change.
- Design functional/initiative-level change plans in partnership with R&D Functional Heads, the Integration Management Office, Corporate Affairs, and other strategic initiative leaders. Liaise with key partners across R&D to ensure company-wide change imperatives are incorporated and reinforced in the R&D-wide change management program and minimize the risks to business disruption.
- Collaborate with key Executives and other leaders across the enterprise to ensure that R&D Change Management aligns with BMS and R&D business strategy and strategic roadmap.
- Manage complex cross functional stakeholder alignment and issue and risk resolution.
- Create clear and efficient communication strategies in collaboration with Corporate Affairs and enterprise/functional/initiative representatives.
- Use a structured change management methodology (e.g., process and tools) to guide portfolio-level and initiative-level change management activities.
- Contribute to an R&D change community of practice as a mechanism to foster a robust change management community and to amplify the impact of our change strategy.
Experience desired:
- BA/BS degree required; advanced degree preferred
- 7-10 years of pharma industry experience preferred
- Strong working knowledge of pharma industry landscape, forces, and trends
- 10-15 years of change management or relevant complex organizational transformation experience required
- Demonstrated track record converting complex challenges into clear plan of action and driving large cross-functional enterprise change initiatives to deliver intended business outcomes
- Track record in developing and implementing successful business strategies in complex and global environments
- Deep knowledge and practical application in the area of business strategy implementation
- Experience working effectively with business/technology/innovation leaders to integrate change to drive results
- Demonstrated ability to collaborate across functions in a highly matrixed organization global setting
- Strong problem solver and facilitator, especially in highly ambiguous situations
- 10 years M&A and post-merger integration experiences are a plus
- Experience in innovation and technology sector is a plus
Key skills desired:
- Ability to navigate ambiguity in a fast-paced environment
- Strong business acumen and understanding of organizational challenges
- Ability to make the complex more easily understood through written narrative, visuals representations and clear presentation decks.
- Possess excellent written and verbal communication skills, including the ability to deliver executive presentations
- Experience and knowledge of change management principles, methodologies, and tools
- Strong ability to flex and influence across critical stakeholders to drive enterprise agenda
- Exceptional cross-functional / matrix / project leadership skills
- Organized with demonstrated strength in planning strategy and tactics
- Proven track record of balancing broad enterprise change strategies with pragmatic on the ground solutions that increase adoption and usage of desired change efforts
- Recognizing and accommodating diverse regional and organizational needs in change strategies
- Strong problem solver and facilitator, especially in highly ambiguous situations
- Strong developer of effective partnerships and relationships with all levels
- Commitment and passion for achieving desired outcomes (i.e., value, quality, speed, cost)
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, 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.
In this role the Project Coordinator is expected to provide support in implementing Occupational Health services, as well as reporting to the Site Manager, Occupational Health Summit West. This position support the Summit East, Berkeley Heights and Warren facility and also collaborates with other on-site staff, as well as other members of the Occupational Health team. The Occupational Health program complies with BMS Corporate Policies and Directives as well as federal and state occupational health and safety regulations and laws.
General Responsibilities:
- Performs complex and diverse administrative duties that require attention to managing multiple, shifting priorities and attention to several urgent issues at once
- Apply core competencies in simple and routine situations and decision making
- Proactively manage calendars, as well as schedules, and organize complex activities such as department calendars, meetings, travel, conferences related to activities across the Occupational Health Team.
- Coordinate and answer correspondence and assemble highly confidential and sensitive information
- Develop, maintain, and update electronic and paper filing systems for the department
- Presents information clearly and effectively in written and verbal formats to multiple levels of internal and external audiences
- Act as department liaison among internal departments in overseeing requests for Occupational Health.
- Work independently and serve as a team contributor for special nonrecurring and ongoing projects including time sensitive, and practice area specific projects
- Ability to demonstrate a capacity to develop new skills and learn new software applications
Position Requirements:
- Bachelor’s Degree preferred
- Bilingual preferred
- Experience in project coordination and/or management preferably within pharmaceutical, legal, or regulatory industry
- Strong collaboration and communication skills, including the ability to operate in a highly matrixed environment and work cross-functionally while interacting with employees across sites, and the company at all levels
- Excellent communication skills-both verbal and written
- Strong organizational and execution skills with the ability to deliver to deadlines
- In-depth knowledge of MIE, Microsoft Suite and SharePoint, OneNote
- Experience in Travel and Expense - Ariba and SAP preferred
- Mastery of Excel for sorting, formatting, and analysis of data
- Ability to set priorities and to work proactively and independently
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Manufacturing/Ops
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, 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
Reporting to the Cell Therapy Capability Center Lead, within Global Manufacturing Science and Technology, this is a key role to assist in the mission of the Cell Therapy Capability Center (CTCC) to harmonize and develop effective global training and learning content to assist the BMS Cell Therapies manufacturing sites in successfully providing life-saving cell therapies for patients.
The CTCC was started in 2020 to help with the standardization of process specific training curricula to assist the different manufacturing sites, and to assess gaps and needs across sites and for new sites coming into the BMS Cell Therapy network. The CTCC also is responsible for piloting new innovative solutions and technologies to enable learning, such as VR and AR. This role will also help to guide and participate in defining and refining the future state of the CTCC, to include the build out of a centralized facility for hands on and classroom training in Summit, NJ.
The successful candidate will be responsible for harmonizing existing training, assessing needs, designing, developing, and evaluating new training materials and approaches. The Senior Specialist will collaborate with the Cell Therapy Validation team, MSAT project teams, internal and external manufacturing teams to ensure training needs are assessed and met, and training solution implementations are successful. The CTCC team will enable mindset and behavior changes to ensure compliant reliable supply through developing and implementing training and capability building programs. Also, they will collaborate with counterparts in the Cell Therapies network to leverage expertise and knowledge across modalities and will ensure manufacturing process specific knowledge is transferred from tech transfer SMEs to manufacturing operators in a sustained manner beyond the HyperCare phase of tech transfers by creating job aids, reinforcement strategies and other mechanisms.
Key Responsibilities
- Evaluate existing training, harmonize content and implement standards for training new employees and new sites for the network.
- Support the standardization and linking of site-based training, global training and continuous learning.
- Assess and prioritize incoming needs for learning solutions and support collaboration and assessment of global training needs across the many global manufacturing sites.
- Support and develop innovative learning for increased skills retention and virtual platforms (Augmented Reality, Virtual Reality, etc.)
- Assist in identifying, assessing and vetting external groups Needed to assist in meeting site and global training needs training.
- Support the life cycle management and continuous improvement of the CTCC.
- Assist or Lead implementation of pilots and training programs at key sites or for key groups.
- Work with sites to define and finalize the centralized training center (Summit,NJ) for content, equipment, and program requirements.
- Ensure manufacturing process specific knowledge is transferred from tech transfer SMEs to manufacturing operators in a sustained manner beyond the HyperCare phase of tech transfers by creating job aids, tools and other mechanisms.
- Excellent team player and cross functional collaborator.
- Good understanding of training principles, concepts and expectations.
- Preferred Qualifications -
- Experience in Cell Therapy manufacturing and analytical requirements and best practices from theory, science and practical manufacturing applications and instrument use.
- Experience in GMP training environment.
- Understanding of learning technology and or AR/VR concepts.
- Experience working on global projects with cross-functional teams.
- Travel as required to various sites ~25%
Qualifications & Experience
- Required Bachelor’s Degree or relevant experience in Life Sciences, Instructional Technology, Instructional Design, or Engineering.
- Minimum 2 years of experience in pharma/biotech or instructional design.
- Experience with instructional design, training, and/or curriculum assessment, design, and development.
- Preferred to have a degree or certificate(s) in Instructional Design ex - Langevin, ATD, 6Ds, EdX, LinkedIn Learning/Lynda, Mini Masters in Instructional Design / Instructional Technology.
- Demonstrated ability to work with leaders and develop strategy and implement large scale changes.
BMSCART
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Qlty Assurance Methods
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, 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.
The Associate Director Document Control & Label Control is responsible for directing the Quality Assurance Document Control and Label Control operations in accordance with BMS policies, standards, procedures and Global cGMPs.
In this role, the incumbent will direct and motivate team members, build trust, and cultivate a collaborative environment between the groups and key stakeholders, both locally and globally. In addition, the incumbent will be responsible for representing the Summit West Cell Therapy Doc Control and Label Control teams on various multi-site and global teams.
The Quality Assurance Document Control organization is responsible for processing, and issuing GMP documentation (i.e. batch records, ancillary documents and labels, logbooks, and forms). This group is also responsible for the external archiving of GMP records.
The Quality Assurance Label Control organization is responsible for the establishment, maintenance, and continuous improvement of the clinical and commercial label control process, procedures, and responsibilities for achieving quality policies and objectives.
Both organizations support the S12 manufacturing facility to ensure patient safety, regulatory requirements, and improve its effectiveness and efficiency on a continuous basis.
Work scope includes clinical and commercial manufacturing for all Cell Therapy products manufactured in S12 facility.
This position is based in Summit, NJ, and reports to the Director Quality Assurance CAR T.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.