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.

Key Responsibilities and Major Duties:

• Handle authority request and notifications by collaborating with Regulatory and Quality Assurance department, and coordinate within BMSKK accordingly.
• Manage the change appropriately for market-authorized products in cooperation with BMS Global as well as BMSKK associated departments.
• Regarding the change control proposed by BMS-Global, coordinate with relevant internal departments, and appropriately assess the impact on Japan.
• Manage discrepancies between the approved file (site information, manufacturing processes, testing items and other necessary information) and the actual manufacturing situations.
• Periodically check whether there is any discrepancy between the approval file (Manufacturing site information, manufacturing process, test/inspection items, and other necessary information) and the actual manufacturing status.  If any discrepancy is found, draw up a regulatory strategy and respond to the regulatory authority in cooperation with related departments.
• Formulate and propose regulatory strategies such as application for GMP/GCTP compliance inspection and Foreign Manufacturer Accreditations renewal. Also, complete these tasks as scheduled.
• This position can be a designee for a director of MAH license and compliance for GMP compliance inspection submission and FMA management, AF verification, change control and GMP/GCTP audit verification.

Required Knowledge and Skill

Knowledge

• Knowledge of Pharmaceutical & Medical Device Act. and related regulations, GQP ministerial order and GMP ministerial order.
• Basic knowledge of DS/DP manufacturing, packaging operation, quality control testing and Japanese Pharmacopoeia.
• Knowledge of regulatory application for obtain/renew Foreign Manufacturer Accreditations and periodical GMP compliance inspection etc.

Skill

• Communication skill for achieving good relationship with authorities and connected departments.
• Strong leadership skill to perform cross functional tasks.
• Logical thinking to make regulatory strategy.
• Capability to have Global team and foreign manufacturers understand pharmaceutical regulations and notifications that is imposed to Japanese Market Authorization Holder. 
• Capabilities to obtain accordingly, information necessary to obtain/renew Foreign Manufacturer Accreditations and periodical GMP compliance inspection from the manufacturers (API site, Formulation site, etc).
• Capabilities of analysing the supervising results of manufacturing sites and make instructions for improvement if necessary.
• Skill to negotiate with PMDA officer on regulatory application and inquires.

Language skills

• Communication skills in fluent Japanese and business level of English
• Analyse English documents

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 primary focus of this role is the delivery of the Veeva Quality portfolio. This position is responsible for the planning and execution of assigned projects supporting Quality functions, reporting to the Veeva Platform lead in India center. This role will oversee approximately 6+ FTE’s (Veeva developers and testers) and will have accountability to drive both implementation and operations of Veeva Quality Capabilities working with internal teams, contractors and Veeva product team.

Desired Candidate Characteristics:  

• Have a strong commitment to a career in technology with a passion for healthcare   

• Ability to understand the needs of the business and commitment to deliver the best user experience and adoption   

• Able to collaborate across multiple teams    

• Demonstrated leadership experience   

• Excellent communication skills   

• Innovative and inquisitive nature to ask questions, offer bold ideas and challenge the status quo   

• Agility to learn new tools and processes 

• Veeva White Belt certification

• 5+ years' experience with validated system Computer System Validation (CSV)

• 3+ years Quality Vault experience

• Experience with QMS , Quality Docs applications.  

Key Responsibilities:

• Owns end-to-end accountability for managing technology assets, ensuring they are reliable, accessible, and secure

• Hire, Manage and mentor group of Veeva Developers in domain in India center

• Leads operational activities such as maintenance and break-fix releases, security assessments, regulatory risk assessments, incident response, etc.

• Manages the build, run of technology assets, and ensures timely delivery of releases (Veeva Vault General Releases, Operational Releases, and Project Releases)

• Collaborates closely with the Veeva Drug Development & Quality Cloud team to obtain a working knowledge of the Veeva Vault platform and the various domain-specific Vaults

• Partners with IT Business Partners and Business Subject Matter Experts to define, plan for, prioritize, deliver, and support the systems and ensure maximum value is achieved

• Ability to understand, prioritize, and communicate IT needs to our business colleagues and stakeholders

• Designs technical solutions to satisfy business requirements

• Fulfills all approved, technology asset-specific business needs

• Obtain/maintain a Veeva Associate Administrator Level certification

Qualifications & Experience

• Requires thorough knowledge of the principles and concepts of a discipline and developed knowledge of other related disciplines, typically gained through a university degree and 7+ years of experience.  Responsible for leading a small team (results/outcomes, goal setting, input into performance management and coaching). Actively participates in troubleshooting of routine problems. Makes decisions that impact own team and other groups/teams. May represent team or function on program or project teams. 

• People manager with experience working in matrix setup and responsibility for Individual contributor positions  

• Responsible for a sub-function's work in a team leader capacity.​ 

• Persuades and negotiates effectively with stakeholders in being able to coordinate actions for achieving the desired outcome. ​ 

• Articulates and presents complex information clearly and concisely across all levels. Demonstrates abilities and knowledge in being able to explain and present complex topics clearly.​ 

• Participates in decision making and brings experiences and ideas to achieve team objectives. ​ 

• Identifies short-term and long-term development goals aligned with current capabilities. Supports and coaches the team in continued learning and improving capabilities.​ 

• Looks to improve processes, structures, and knowledge within the team. Leads in analyzing current states, delivers strong recommendations, and able to execute to bring moderately complex solutions to completion.​ 

• Applies understanding of internal/external challenges to contribute to the team's vision and maintains a focus on work in accomplishing operational goals. 

• Evaluates complex issues through analytical thinking and previous experience to consider short and long-term implications and interdependencies and guides others when enough analysis has been completed in giving recommendations/solutions.​ Uses calculated risks to evaluate innovative solutions. 

#HYDIT #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.

BMS encompasses a broad range of disciplines to enable a robust pipeline of drug candidates aimed at serious diseases.  Chemistry is a core capability in Small Molecule & Drug Discovery with innovative scientists working in medicinal chemistry, radiochemistry, analytical chemistry, and large-scale synthesis.  Within SMDD our Lead Discovery and Optimization (LDO) team is responsible for high throughput screening, compound storage and distribution, primary assays to support discovery programs, and compound profiling to explore drug liabilities in vitro.   LDO scientists discover and adopt cutting edge assay technologies that utilize state-of-the-art automation to drive speed and efficiency.  Our Molecular Structure and Design team embraces novel approaches to computer-aided drug design, machine learning, and structural biology.  The integration of these disciplines provides a seamless and highly interactive environment for discovery scientists to learn, develop, and innovate.  Working in partnership with our disease area experts in the Thematic Research Centers provides an exciting pathway to discover and deliver medicines to patients in need.

We seek a highly motivated and innovative scientist to join our cell and genome engineering team. The successful candidate will participate in the development of engineered cell models in a fast pace setting to contribute to one of the basic foundations in the process of small molecule drug discovery. This individual will collaborate across Bristol Myers Squibb’s many sites and therapeutic areas to provide essential cellular reagents and data to initiate and progress drug discovery programs. To be effective in this position the successful candidate will need to possess a broad and strong technical background in cell and molecular biology as well as in emerging functional genomics technologies and more importantly be capable of implementing and adapting these novel approaches to cell line engineering. The successful candidate for this laboratory-based position will also be expected to collaborate effectively with academic and industry partners and be able to translate the knowledge gained from those collaborations into effective research driven solutions.  This position is designed to enable Bristol-Myers Squibb to maintain a leadership position in the application of novel and innovative cellular and genomic approaches to enable the drug discovery process.

The successful candidate will have:

• Deep understanding of the human genome, its organization, and how it relates to gene expression.
• Working knowledge of CRISPR Cas9/Cas12a/dCas9 and the associated molecular biology/genome sciences to implement the above for the creation of cellular models to advance drug discovery programs.
• Have experience in the manipulation of a diverse collection of cell lines and primary cell models.

• Be well versed in genomic sequence analysis and bioinformatics approaches for project designs, clonal genotyping, and final sequence verification.

• Have strong analytical and data analysis skills.
• Ability to manage projects across functional lines and geographic locations.
• Strong written & verbal communication skills for presenting data and ideas to multiple stakeholders across disciplines.
• An intense desire to leverage and apply new approaches to the field of drug discovery and make a profound impact on the lives of patients.
   

Basic Qualifications:

Bachelor’s Degree with 5+ years of academic or industry experience

Or

Master’s Degree with 3+ years of academic or industry experience

Or

PhD in Molecular/Cellular Biology, Biochemistry, Bioengineering with no experience

Preferred Qualifications:                                                                                                                       

• PhD in Molecular/Cellular Biology, Biochemistry, Bioengineering or related field.
• Demonstrated expertise in the creation of genetically modified cell lines (knockouts, knock-ins, overexpression) using a variety of technologies and approaches, including but not limited to CRISPR, lentiviral, and transposon mediated approaches.
• Strong cell biology background, especially in the culturing and manipulation of cancer cell lines, iPSCs, primary cells, including enteriods and organoids.
• Previous experience with various NGS platforms (e.g. Illumina MiSeq, NextSeq2000), and the analysis of clonal level sequencing data would be considered a plus.
• Previous experience with ddPCR and TaqMan.
• Publications resulting from PhD-level research experience would be highly advantageous.
• Demonstrated excellence in written and oral communication.
• Strong desire to succeed in cross-functional teams and collaborate in a highly matrixed environment.
• Working knowledge of the overall drug discovery process would be considered a plus.
• Applicants should be detail-oriented, highly organized, and able to multi-task with multiple projects.

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.

Poste: Gestionnaire, Évaluation des Technologies de Santé et Accès au Marché

Lieu: Montréal (Saint-Laurent), Québec

Type de poste: Contrat de 12 mois

Chez Bristol Myers Squibb, nous sommes inspiré(e)s par une seule vision : transformer la vie des patients grâce à la science. Dans les domaines de l’oncologie, de l’hématologie, de l’immunologie et des maladies cardiovasculaire et l’un des pipelines les plus prometteurs de l’industrie, chacun(e) de nos collègues passionné(e)s contribue aux innovations qui entraînent des changements significatifs. Nous apportions une touche humaine à chaque traitement dont nous sommes les pionniers. Notre organisation suit une structure de travail hybride où les employés peuvent travailler à distance ou au bureau 50 % du temps. Rejoignez-nous et faites la différence.

Description du poste

Remplacement temporaire pendant un congé maternité jusqu’en septembre 2025 avec la possibilité de devenir un poste permanent. Relevant du directeur, Stratégie accès au marché, cette personne sera un joueur d'équipe très précieux qui pilotera des stratégies de remboursement afin de maximiser l’ajout des produits Bristol-Myers Squibb aux formulaires des payeurs publics et privés au Canada.

Responsabilités clés et tâches principales:

Le rôle de gestionnaire, Évaluation des technologies de la santé et accès au marché comprend ce qui suit :

• En collaboration avec les équipes interfonctionnelles, identifier et développer des stratégies et des tactiques pour améliorer la proposition de valeur des produits BMS grâce à des initiatives/activités innovantes et efficaces de remboursement et d'évaluation des technologies en santé (ETS) pour soutenir les soumissions aux payeurs publics et privés ;

• Développer des dossiers de valeur convaincants basés sur les évidences cliniques et pharmacoéconomiques des produits BMS auprès des payeurs publics et privés canadiens;

• Préparer des soumissions pour les ETS de haute qualité en temps opportun;

• Assurer la liaison avec les agences d'ETS (AMC, INESSS), les régimes d'assurance-médicaments provinciaux/territoriaux, les payeurs privés, les experts ;

• Forger des relations avec les membres de l'équipe interne d'accès au marché pour développer des stratégies liées aux questions politiques clés soutenant les objectifs commerciaux;

• Gérer les projets et les budgets selon les objectifs et les délais fixés ;

Expérience/compétences requises:

• Un minimum de 2 ans d'expérience de travail pertinente;

• Expérience antérieure dans l'industrie pharmaceutique, en particulier avec une responsabilité fonctionnelle dans l'économie de la santé et la planification du remboursement de médicaments;

• Solide compréhension du paysage canadien de la tarification et du remboursement des médicaments, de l'ETS et des formulaires de médicaments;

• Faire preuve de passion, d'innovation, de responsabilité, de leadership stratégique et de rapidité ;

• Capacité à équilibrer la réflexion stratégique avec une planification complexe et une solide exécution tactique dans un environnement matriciel et interfonctionnel;

• Prioriser efficacement et gérer plusieurs projets simultanément;

• Capable de comprendre et de communiquer de manière claire et concise une grande quantité d'informations scientifiques;

• Bilinguisme (en anglais et en français) requis.

Éducation:

• Professionnel de la santé, MSc, PharmD ou PhD avec expérience en épidémiologie/économie de la santé/ETS ou dans des domaines connexes ;

• Excellente connaissance de Microsoft Office (Word, Excel, Power Point).

Pourquoi postuler

À travers le monde, nous sommes passionné(e)s par la volonté d’avoir un impact sur la vie des patients atteints de maladies graves. Nos valeurs communes de passion, d’innovation, d’urgence, de responsabilité, d’inclusion et d’intégrité font ressortir le potentiel le plus élevé de chacun(e) de nos collègues.

Bristol Myers Squibb reconnaît l’importance de l’équilibre et de la flexibilité dans notre environnement de travail. Nous offrons une grande variété d’avantages, de services et de programmes compétitifs qui fournissent à nos employé(e)s les ressources nécessaires pour poursuivre leurs objectifs, tant au travail que dans leur vie personnelle.

Nous vous invitons à transmettre votre curriculum vitae en ligne et nous nous ferons un plaisir de vous contacter si votre candidature est retenue pour une entrevue dans nos bureaux de Saint-Laurent. Au plaisir de vous rencontrer!

Position: HTA-Market Access Manager

Location: Montreal (Saint-Laurent), Quebec

Job type: 12 Month Contract

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. Our organization follows a hybrid work structure where employees can work remotely or from the office 50% of the time. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Job Description

Temporary maternity leave coverage until September 2025 with the possibility of transitioning into a permanent role. Reporting to the Director, Market Access Strategy, this person will be a highly valuable team player who drive successful reimbursement strategies to maximize formulary listings of Bristol-Myers Squibb products with public and private payers in Canada.

Key Responsibilities and Major Duties:

The Manager, Health Technology Assessment and Market Access role entails the following:

• In collaboration with cross-functional teams, identify and develop strategies and tactics to enhance the value proposition of BMS products through innovative and effective reimbursement and HTA initiatives/activities to support public and private payers submissions;

• Develop compelling value dossiers to establish the clinical and pharmacoeconomic evidence of value of BMS products with Canadian public and private payers;

• Prepare high quality health technology assessments (HTA) submission on a timely manner;

• Liaise with HTA agencies (CDA, INESSS), provincial/territorial drug plans, private payers, experts;

• Forge relationships with internal market access team members to develop advocacy strategies related to key policy issues supporting business objectives;

• Manage projects and budgets within set targets and timelines;

Experience/Skills Desired:

• A minimum of 2 years relevant work experience;

• Previous experience in pharmaceutical industry, especially with functional responsibility in health economics and reimbursement planning and program implementation preferred;

• Solid understanding of Canadian drug pricing/reimbursement landscape, HTA and drug formulary;

• Demonstrate passion, innovation, accountability, strategic leadership and speed;

• Ability to balance strategic thinking with intricate planning and strong tactical execution within a matrix, cross-functional environment;

• Prioritize effectively and manage multiple projects concurrently;

• Capable of comprehending and communicating in a clear, concise manner a large amount of scientific information;

• Fluent bilingually (in English and French) required.

Education:

• Health care professional, MSc, PharmD, or PhD with experience in Epidemiology/Health Economics/ HTA or related fields;

• Excellent knowledge of Microsoft Office (Word, Excel, Power Point).

Why You Should Apply

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion, and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

We invite you to forward your resume online and we will be happy to contact you if your candidacy is selected for an interview in our offices in Ville Saint-Laurent. Looking forward to meeting you!

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.

Job Title  

Phase IV Senior Global Trial Specialist 

Division  

Research and Development 

Functional Area Description 

 Crossing all therapeutic areas and research phases, collaborate with cross-functional global teams to execute on assigned operational aspects of complex global clinical research studies from protocol development to final clinical study report.  

Position Summary 

• Contributes to the operational execution of clinical studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs/WPs.  

• Participates on one or more cross-functional study team(s) and/or performance and quality oversight of one or more Contract Research Organization (CRO) teams and vendors.  

• Primarily works on routine to complex projects/trials at varying stages and supports multiple complex trials as needed.  

• Contributes to achieving corporate and study team goals, successfully completes assigned tasks, participates in service provider oversight, and sets priorities with guidance.  

• Proactively manages multiple assignments and operational processes with moderate to minimal supervision.  

• Has high functional impact on the study team and the organization.  

Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned.  

Position Responsibilities 

 Responsibilities involve a combination of execution and oversight, dependent on the sourcing model, to ensure deliverables and may include, but are not limited to, the following:  

Project Management  

• Provides operational input and facilitates in operational processes as a SME in support of the startup maintenance and close out of studies.  

• Uses performance metrics and quality indicators to assist the Global Trial Manager in driving study execution.  

• Proactively identifies potential risks and develops/implements actions to avoid or mitigate.  

• Resolves routine problems and escalates important issues appropriately and with a sense of urgency.  

• Actively contributes as a key functional member on cross-functional teams.  

Study/Project Planning, Conduct and Management  

• Provides and support input to study level tools and plans while working with moderate to minimal supervision.  

• Independently performs core GTS tasks and escalates/pushes back/delegates appropriately.  

• Actively contributes to study meetings by leading some components.  

• Contributes to oversight of the required country regulatory (e.g., CTA, MoH) and country/site IRB/IEC approvals/notifications.  

• Flexibility to work on various trials at varying stages/complexity with minimal guidance as needed.  

• Understands strategy and decision making at program level and their impact on the studies.  

• Ability to contribute to initiatives for process development and improvement.  

• Ability to assess a situation and identify path forward with the appropriate resources.  

• Understands interdependencies of tasks assigned.  

• Manages vendors and site payment processing and tracking.  

• Facilitate the maintenance of study budget tracking tools and reconciles invoices with overall contract/budget and finance reports.  

Degree Requirements 

BA/BS or equivalent degree in relevant discipline  

Experience Requirements 

• Minimum 1 year experience in Clinical Research or related work experience.  

• Experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems.  

• Global experience is required.  

Key Competency Requirements 

Technical Competencies  

• Knowledge of ICH/GCP, regulatory guidelines and directives, and the drug development process.  

• Knowledge of clinical research budgets including processing and tracking of site and vendor payments is preferred.  

• Working knowledge of project management preferred.  

Management Competencies  

• Begin to network and foster relationships with key stakeholders across the study team.  

• Responds flexibly to changing business demands and opportunities, proactively looking for ways to contribute.  

• Acts as a role model in supporting change within the organization and has knowledge of cross-functional partners who can help clarify change.  

• Mentors and coaches other team members and GTS’, as appropriate, and participate or provide leadership in departmental initiatives.  

• Builds relationships to achieve influence with others.  

• Develops and maintains collaborative relationships with internal and external stakeholders to be more effective in the role.  

• Displays a willingness to challenge the status quo and take risks  

• Effective oral and written communication skills, ability to across the matrix, organization, and to key stakeholders  

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.

Department: Manufacturing – Compliance and Support
Job Title: Specialist III

Background: The Specialist, Manufacturing Compliance & Support contributes in a team that directly support Manufacturing floor operations. The Manufacturing Compliance team is a part of the overall manufacturing team and is organized around floor-enabling deliverables through compliance programs, quality systems, training, finite scheduling and equipment lifecycle support. We are looking for multiple specialist positions at different levels within this team.

Responsibilities (included but are not limited to):
· Drive specialist group to meet daily deliverables
· Coach and mentor junior specialist staff
· Provide front line support for manufacturing operations
· Support manufacturing continuous improvement projects
· Partner with Manufacturing Science and Technology team
· Investigates and coordinate the resolution of deviations through use of Root Cause Analysis tools and product impact assessments.
· Issues and implements CAPAs to address root cause and ensure effectiveness
· Collaborating with appropriate stakeholders to write and/or revise applicable SOPs, batch records, and other operational related documents
· Participates in internal audit/inspection
· Represents Manufacturing operations in Change Control, CAPA and Deviation meetings
· Conducts technical training for manufacturing operations
· Other tasks and duties as assigned by Management

Experience & Qualifications:
The ideal candidate for this position of Manufacturing Compliance and Support Specialist III is highly skilled flexible worker with strong people skills and an extensive background in cGMP manufacturing.
· Bachelor’s or Master's degree in sciences (for instance: Biochemistry, Life Science & Technology, Biology).
· A minimum of 7 years of cGMP production experience
· Strong analytical and problem-solving skills
· Strong leadership skills
· Sound knowledge and understanding of process, documentation requirements, systems and equipment to troubleshoot problems and provide solutions to management
· Knowledgeable of Current Good Manufacturing Practices (cGMPs)
· Expert knowledge of electronic quality systems.
· Knowledge of equipment and systems related to manufacturing operations (i.e. MES, eBR, Sepax, CliniMACs, LOVO, etc.)
· Knowledge of KPI generation and reporting
· Expert knowledge of quality record ownership (CAPA/CC/Dev)
· Experienced in providing and assessing performance related to manufacturing operation technical training

Skills:
· Excellent verbal, technical writing and interpersonal skills
· Excellent communication skills in English, both written and spoken
· Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
· Ability to work efficiently and accurately on multiple projects simultaneously to meet set goals and timelines.

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.

External / Field Activities:
1. Scientific Exchange with Thought Leaders
Proactively and/or reactively interact with healthcare providers, as appropriate, through face-to-face meetings and other available means of communication, by focusing on activities described in Medical plans, in alignment with the customer-centric model and overall therapeutic area/brand strategies.

Develop and maintain contacts with Thought Leaders, in accordance with the strategy to further understand and gain both insight and/or input into treatment patterns, unmet medical needs, patient needs and behaviors.

Ensure appropriate response to unsolicited scientific questions or requests posed by Health Care Providers for approved products (in and off label), and for products in development.

Contribute to involvement of Thought Leaders, as required and as appropriate, in BMSsponsored studies and other scientific activities.

2. Collect and communicate Field Medical Insights (FMI)
Profiling of medical landscape within the Disease Area and continuously update this knowledge, including expertise in products, patient treatment trends, unmet medical needs, clinical trials and scientific activities.

Ensure awareness of current Key Insight Topics and Questions and proactively contribute insights gained from healthcare provider interactions to relevant internal stakeholders.

3. Provide Medical Services to External Customers
Liaise appropriately and effectively with the Medical Information department to develop a systematic follow up interaction plan with Health Care Providers to ensure customer satisfaction with the information received in response to their unsolicited scientific questions or requests; and is prepared to discuss these responses and/or expand on the content upon the HCP’s request.

Exhibit a high degree of familiarity with, and proficiency in, centrally developed scientific resources and presentations. Present information to HCPs, as appropriate, ensuring medical accuracy and compliance with local procedures/regulation, ethical, and legal guidelines.

Identify appropriate candidates for the local speaker bureau

Key facilitator during formal Speaker Training meetings, and/or through regular one-to-one education, ensuring speakers are skilled on the latest approved resources.

4. Provide clinical trial support, Clinical Trial/Survey Identification, Planning and Execution

Lead the identification, at an early stage, of potential opportunities for country
participation in clinical development programs. Lead early mapping of centers of excellence, treatment trends and recruitment potential in untapped therapeutic areas / with new compounds.

Contribute to the ‘early prioritization’ of development programs for the country by integrating data on disease incidence / prevalence, treatment patterns, unmet medical needs and interest from the scientific community.

Participate actively in providing input to the RCO Hub on trial and survey feasibility and site suitability, based on knowledge of the field and through direct contacts with potential investigators.

Facilitate clinical trial activities between BMS and investigators for both BMS sponsored(interventional and non-interventional) and Investigator sponsored trials).

Provides support to the Clinical Site Manager, as requested and as per Scope
document, for site support activities relating to the conduct of a BMS sponsored clinical trial.

Internal / Medical Strategy Activities:
1. Country Medical Strategy Key Contributors
Generate and execute the Local Medical Plan, and contribute to the development of integrated Local Brand Plans and strategies with reference to recent publications around patient’s needs and treatment trends, and as derived from contacts with Thought Leaders
and other HCPs or payers.

Identify the need for Consultants and/or Advisory Boards and execute
engagements according to strategy.

Contribute to the development of scientific publications or presentations, as appropriate.

Lead development and execution of educational Programs and Symposia and ensure flawless execution of such activities, where permitted.

2. Medical support for internal stakeholders
As appropriate, contribute to the initial and ongoing medical/scientific disease area and product-specific training of internal and field-based BMS personnel (Brand team, Sales force, Clinical Operation, etc), enabling understanding and balanced communication of the scientific benefits and clinical values of brands.

Provide scientific support to Internal Stakeholders, specifically but not limited to Marketing, Regulatory, HEOR, Pharmacovigilance, Legal Counsel and Market Access.

Contribute to the execution of Medical Education activities by reviewing the proposed presentations for scientific rigor and accuracy, where Company policies, and applicable laws, regulations and ethical standards permit it.

Promotional Material Contributor & Reviewer
Contribute to the development of clinical data to be included in promotional materials and review the overall material.

3. Compliance
􀁸 Endorse and implement a culture of compliance
􀁸 Develop an understanding and competence of SOPs, GCP and ICH, as well as legal and ethical standards
􀁸 Immediately alert management or the Compliance Department to any possible compliance issues

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.

BMS Hyderabad is an integrated global hub where our work is focused on helping patients prevail over serious diseases by building sustainable and innovative solutions. This important science, technology, and innovation center will support a range of technology and drug development activities that will help us usher in the next wave of innovation.
Functional Area Description

Global Trial Managers, crossing all therapeutic areas and research phases, collaborate with cross-functional teams to drive operational aspects of complex, global clinical research studies from concept to final clinical study report. Position Summary / Objective

• Provides strategic and operational leadership of clinical research studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs/WPs.

• Independently leads complex, large, global in-house or outsourced, NonRegistrational Data Generating or Registrational Data Generating trials/studies at any point in the life cycle of the trial/study (i.e. start up, maintenance, or close-out).

• Acts as the primary operational contact for the study and leads the crossfunctional global team for execution of the study. • May provide operational leadership of one or more cross-functional Study Team(s) and/or performance and quality oversight of one or more Contract Research Organization (CRO) teams and vendors.

• Has high global organizational impact and influence, and significant impact on function and Study Team.

Position Responsibilities

Responsibilities involve a combination of execution and oversight, dependent on the sourcing model, to ensure deliverables and may include, but are not limited to, the following:

Project Management

• Directs and delegates to the assigned Global Trial Management Staff as applicable

• Drives study execution utilizing available performance metrics and quality indicators and study milestones and drivers

• Oversees clinical monitoring quality and adherence to established processes and plans.

• Develops, manages, and maintains study deliverables (i.e. timelines, study plans, etc.) through collaboration with internal and external stakeholders using data and strong interpersonal influencing skills to make robust data driven decisions.

• Proactively identifies potential risks and develops/implements actions to avoid/mitigate and make the appropriate trade-offs of balancing risks with study deliverables and costs.

Job Description

• Maintains/updates data as appropriate in project management tools including CTMS.

• Troubleshoots complex issues with little guidance and support.

• Informs operational program lead(s) and other leadership (as appropriate) on overall clinical trial plans, recruitment status, and raises potential issues/mitigation.

• Leads, develops, and implements cross-functional/global initiatives and best practices.

• Creates, maintains, and implements project management tools at the study level (e.g. actions, decisions, issues log and risk management plan). Study Planning and Conduct

• Supports and oversees country and site feasibility/selection processes with use of robust data.

• Provides operational and strategic input into Study Team and study documents.

• Collaborates with CSO on global investigational product [IP] supply forecasting/management.

• Participates in the subject recruitment/retention strategy and related initiatives (e.g. recruitment material).

• Participates in clinical service provider (vendor) selection, specification development, and management/oversight.

• Oversees TMF set-up, ongoing quality review, operational oversight memo, and requests final reconciliation.

• Provides input to and reviews study training for Study Team, investigational sites, and vendors in collaboration with the Clinical Scientist. • Oversees study specific CSR appendices.

• Provides input and communicates with the appropriate teams for response to country/regulatory and IRB/IEC.

• Proactively manages issues and information sharing with key internal/external stakeholders with use of standardized reports and other mechanisms.

• Highly proactive risk identification, contingency planning, innovative problem solving, and the ability to solve multiple problems with varying degrees of complexity for multiple functions and understands when escalation is needed.

• Oversees service providers without supervision.

• Leads Audit Response Team and CAPA and participates in inspections.

• Supports the development/management/review vendor scope of work (SOW), invoices, and accruals as per the contract, quality requirements, and budget. Relationship Management

• Proactively develops and maintains collaborative relationships with internal partners/stakeholders across the multidisciplinary teams.

• Manages external partners including Contract Research Organizations (CROs), Academic Research Organizations (AROs), and other clinical service providers as applicable.

• Influences key stakeholders inside/outside of the team and capitalizes on established relationships.

Leadership Competencies

• Creates realistic plans that clearly define goals, milestones, responsibilities and results.

• Maintains focus on strategic objectives while accomplishing operational goals.

• Places a priority on getting results with an emphasis on high quality outcomes.

• Holds self and others accountable for accomplishing goals.

• Makes timely, data-driven decisions while balancing against daily priorities.

• Develops and maintains effective working relationships with people across cultures.

• Encourages collaboration across teams, functions, and geographies. • Ensures that conflict is handled constructively so that performance is not impacted.

• Displays a willingness to challenge the status quo and take risks.

• Responds resourcefully to changing business demands and opportunities, proactively looking for ways the team can contribute.

• Maintains optimism, support and composure in times of change, uncertainty, or stress.

• Executes/delivers on corporate objectives and drives goals. • Leads global cross functional therapeutic programs.

• Creates global solutions for processes.

• Acts as mentor, driver, and motivator to Global Trial Specialist, Associate GTMs, GTMs, and others in the Study Team and function, especially during challenging times.

• Frequently encourages others to consider new approaches and ideas, avoiding getting stuck in a "one right way" approach.

• Models and promotes positive team behaviors in a cross-functional setting by inspiring and holding others accountable for accomplishing goals, building a culture of energy and commitment that challenges people to excel, recognizing and rewarding accomplishments, managing issues, and providing guidance/feedback on performance.

• Can be viewed as a SME by cross functional teams. • May participate in company initiatives, leads continuous improvement initiatives, and shares knowledge where applicable. •

Provides guidance regarding company policies and procedures.

Degree Requirements

BA/BS or equivalent degree in relevant discipline

Experience Requirements

• Minimum 6 years of clinical study management experience of which at least 2 years should have been in direct multinational study management.

• Experience in leading global clinical trials and multi-functional teams.

• Demonstrated project management and organizational skills with strong presentation and communication abilities.

• Experience with electronic quality, compliance and CTMS systems.

• Risk management experience preferred.

• Experience in managing CROs experience is a plus. Key Competency Requirements

• Demonstrated project management and organizational skills with strong presentation and communication abilities.

• Ability to see and understand how work at hand may have program or global implications and follows through to connect appropriate stakeholders Version Technical Competencies

• Strategic clinical trial project management and study management expert. • Intermediate knowledge of clinical trial forecasting, and financial management. • Expert knowledge of ICH/GCP, regulatory guidelines/directives, and drug development and Clinical Trial Process (CTP).

• Expert level cross functional awareness. • Proven success in using oral/written communication skills to influence, inform, or guide others.

• Fosters a continuous learning mindset.

• Computer skills -

Microsoft applications including (but not limited to), Word, Excel, PowerPoint. • Proficiency in study tools including electronic system skills – e.g. CTMS / eTMF

Management Competencies

• Leadership/influence and negotiating management skills.

• Ability to effectively lead a cross-functional team in a matrix environment.

• Time management skills - ability to effectively multi-task and set priorities for self and assists others with the same.

• Has the command of the projects, the ability to zoom in and out as the situation demands and deliver high quality presentations to senior and executive leadership within and outside of BMS (as appropriate).

• Has critical thinking skills for problem solving and the lateral and strategic thinking capacity to drive the study(ies) and understanding the upstream, downstream and lateral implications of decisions that affect study outcomes and timelines.

• Proven problem-solving skills to address and overcome complex safety and compliance related issues during clinical program implementation and execution.

• Excellent negotiating and influencing skills.

• Adaptable and flexible—willing/able to adjust to multiple demands and shifting priorities and demonstrates ability to meet day-to-day challenges with confidence and professionalism.
#HYDDD #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.

主要职责 (岗位相关):
•    有深入的产品知识和疾病领域知识
•    达成/超越区域目标
•    执行市场经理阐明的市场战略。从恰当的细分市场里甄别出目标HCP并与之合作, 达成推广计划
•    充分了解所在地区和所负责区域的关键HCPs
•    更新客户数据
•    协调当地的“院内会议”
•    及时更新HCP的信息，根据计划进行拜访。
•    建立和维护和关键HCP的联系, 理解客户(医学)需求。
•    达成并保持公司关于拜访率、知识水平、能力、行为和个人形象方面的要求。
•    定期（每天）在ETMS 系统中报告拜访情况。
•    提供准确的报告，并且根据规定的流程联系直接主管。
•    提供给直接主管关于BMS 推广材料有效性的信息。.
•    通过参加培训、会议、和自学医学文献以发展和提高专业知识
•    和团队成员分享自己的知识和经验。
•    管理好专业设备和促销资料，确保完好。

岗位要求
•    具备医药，生命科学相关本科以上学历
•    熟悉当地医院的推广工作
•    1-3 年销售经验
•    有肿瘤经验者优先考虑
•    具备良好的人际沟通技巧，团队合作精神，能独立分析解决问题并在压力下工作。

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.

When you join BMS, you are joining a diverse, high-achieving team united by a common mission. 

The Discovery Biotherapeutics team at BMS seeks to understand the structure and function of complex molecules such as bispecific antibodies, antibody drug conjugates and endogenous proteins in order to optimize their utility as therapeutic agents.  We collaborate with biology and translational scientists imbedded in the Thematic Research Centers in order to prosecute Targets and Biological pathways with disease modifying potential. By using a blend of internal and external technologies and capabilities, we work to discover and deliver first-in-class as well as best-in-class molecules that warrant clinical evaluation for patient benefit.

Here, you’ll get the chance to grow and thrive through opportunities that are uncommon in scale and scope. You’ll pursue innovative ideas while advancing professionally alongside some of the brightest minds in biopharma.

Senior Scientist Biotherapeutics Developability

Bristol Myers Squibb is seeking a highly motivated and innovative Senior Scientist with demonstrated expertise in antibody developability and characterization of monoclonal antibodies, bi/multispecifics, Fc-fusion proteins, and antibody-drug conjugates (ADCs) to join our Discovery Biotherapeutics team. Responsibilities will include a range of activities related to antibody and therapeutic protein developability characterization including but not limited to high-throughput plate-based screening for polyreactivity, analytical chromatographic methods for hydrophobicity, molecule integrity and pharmacokinetic prediction, and high throughput assays for manufacturability. This role will work in close collaboration with the protein engineering and characterization teams to test, design and optimize early to late-stage therapeutics to accelerate biotherapeutic discovery. The ideal candidate should also have knowledge/experience in protein chemistry, protein engineering, in silico modeling and prediction, and generation of large high-quality datasets to aid in generating training datasets for AI/ML guided therapeutic design.

Responsibilities:

• Develop and perform plate-based methodologies to address biotherapeutic polyreactivity for a range of modalities including antibodies, bi-/multi-specific antibodies, Fc-fusion, VHH, ADCs, etc.
• Serve as the lead and point of contact on antibody developability, managing requests, performing diverse assays, analyzing, communicating results, and cataloging of all data in databases.
• Execute on early to late-stage characterization for the developability of biotherapeutics including biophysical and bioanalytical methods involving plate-based assays, chromatographic methods, stability and aggregation propensities, structural properties, etc. with the goal of feeding training sets for ML and utilizing the output for improved therapeutic design.
• Demonstrate significant expertise in biophysical and bioanalytical characterization of large molecules to address hydrophobicity, polyreactivity, polyspecificity, self/cross‑interaction, colloidal and conformational stability, aggregation propensity, chemical stability, half-life (PK) predictors, and ADC toxicology predictors.
• Proactively identify liabilities for antibody developability, manufacturability or pharmacokinetics and work with protein engineering teams to guide design and optimization using sequence and computational prediction tools.
• Serve as the point of contact on antibody polyspecificity, managing requests and communicating results.
• Collaborate with multiple project teams in all disease areas to advise on key metrics of antibody developability, polyreactivity, manufacturability, and stability.
• Collaborate with our late-stage manufacturability scientists to support characterization of forced degradation studies.
• Develop new and innovative approaches and methodologies to accelerate early developability/manufacturability testing through miniaturization, increasing throughput and automating assay and data capture.
• Collaborate with the automation engineers for the high-throughput scaling of established assays.
• Prepare and present data and updates to project and functional teams, official reports and SOPs for internal and external purposes, internal documents/reports for regulatory filings.
• Stay current on biophysical and biochemical technologies and relevant literature, recognize risks and propose contingency plans.
• Collaborate with multiple teams across the organization, to support and share methodologies, align on efforts, and harmonize experimentation.
• Manage lab/equipment organization and maintenance.

Basic Qualifications:

Bachelor’s Degree with 7+ years of academic / industry experience

Or

Master’s Degree with 5+ years of academic / industry experience

Or

PhD with 2+ years of academic /industry experience

Preferred Qualifications:

• PhD in Biophysics, Biochemistry or related discipline with 2 years of relevant experience or MS with at least 5 years of work experience. Work experience is ideally in a biotech/pharma/industry environment.
• Proven track record and hands-on experience with biotherapeutic modalities and modern developability/manufacturability assays, methods and workflows.
• Expertise in high throughput plate-based assays including, but not limited to, ELISA, fluorescence, FLISA, HTRF, Flow cytometric, AlphaELISA, etc.
• Extensive experience in analytical liquid chromatograph (HIC, AnSEC, FcRn, Heparin Sulfate, RP, SMAC etc.).
• Demonstrated experience in antibody colloidal stability/self-interaction analysis (e.g. SI-BLI, AC-SINS, kD, viscosity, etc.).
• Experience in antibody conformational/thermal stability (e.g., Tm/Tagg, DSF, DSC, etc.).
• Experience in light scattering methodologies for analysis of biologic modalities and accelerated stability (DLS, SLS, SEC-MALS, Mass Photometry, etc.).
• Experience in biotherapeutic aggregation, solubility, and clipping analysis (AnSEC, Mass Photometry, PEG, CE-SDS, etc.).
• Deep understanding of antibody polyreactivity, stability, solubility, aggregation potential, chemical and other manufacturing liabilities, immunogenicity.
• Advanced knowledge of high throughput developability and pharmacokinetics including assessment and mitigation strategies.
• Familiarity with biotherapeutic manufacturability/accelerated stability testing methods including forced degradation, oxidation, isomerization, deamidation, etc.
• Prior experience with antibody biophysical characterization and binding assays of complex biologics (SPR, BLI, ITC, MST, etc.).
• Deep knowledge in antibody sequence, sequence motifs, and sequence liabilities.
• Broad familiarity with sequence- and structure-based protein modeling tools.
• Experience with high-throughput screening and automated liquid handling.
• Experience with large data generation, analysis and capture (e.g., LIMS systems).
• Exceptional organizational & time management skills, and attention to detail.
• Strong written and oral communication skills are essential.

Skills/Knowledge in one or more of the following areas are a plus:

• In silico modeling and prediction: homology modeling (e.g., MOE, Schrodinger, etc.), correlation of structure-based calculations/properties with experimental data, structure-activity relationship, etc.
• Knowledge/experience in protein and antibody engineering, structure, and design. Collaborate with the protein engineering teams to aid in the design of molecules with improved properties.
• Knowledge of antibody-based and computational databases for analysis and design of sequences (e.g., IMGT, OAS, AlphaFold2, etc.).
• Experience in aspects of structural biology (x-ray crystallography, cyro-EM, nsEM, NMR).
• Experience with programming languages like python, R, etc. is a plus.

For California Sites -  The starting compensation for this job is a range from $109,000 – $150,700, plus incentive cash and stock opportunities (based on eligibility). The starting pay takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation is decided based on demonstrated experience. For more on benefits, please visit our BMS Careers site. Eligibility for specific benefits listed in our careers site may vary based on the job and location.

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.