Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

Position Summary

The CMC Regulatory Associate Director, Small Molecule is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support Small Molecule products regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating/leading HA meetings); and/or post-approval submissions. In this role, the GRS-CMC Associate Director, Small Molecule will serve as the primary interface between Global Regulatory  Sciences (GRS) and Global Product Development and Supply (GPS). The GRS-CMC Associate Director will assess Manufacturing Change Controls for global impact and guide technical teams on practical aspects of global change management.  The position may include direct report(s).

Key Responsibilities

• Participate  on and/or lead matrix teams for small molecule pipeline products and/or commercial products through completion of post-marketing commitments and relevant lifecycle management projects driven by research.

• Independently provide strategic guidance/input related to current regulatory requirements and expectation for small molecule marketing applications, clinical trial applications for projects, and/or lifecycle changes to marketed products, including guidance/input in support of direct reports and their projects.

• Independently manage and prioritize multiple complex projects, including support of direct reports and their projects.

• May interface with the Health Authorities for CMC submissions and CMC-related issues, with guidance and oversite from supervisor on complex topics.

• Identify, communicate and propose resolutions to routine/complex issues

• Interpret global regulations and guidance. Identify regulatory opportunity and risks.

• Anticipate and communicate possible regulatory paradigm shifts.

• May support deviation investigations

• Review and provide regulatory assessments on change controls.

• Prepare and manage CMC submissions for all global markets while ensuring thoroughness, completeness and timeliness, including creation and maintenance of strategy documents.

• Manage relationships with diverse teams.

• Utilize electronic systems for dossier creation and tracking.

• Manage and actively support growth and development of any/all direct reports.

• Strong oral and written skills. 

• Proficient with electronic systems.

• Prior management skills and / or experience preferred.

Qualifications & Experience
 

• Minimum BA/BS Degree

• 7-10+ years Pharmaceutical industry experience, including multi-disciplined experience, 6+ years CMC regulatory strategy. 

• Knowledge of CMC regulatory requirements during development and post-approval and experience with global CMC regulations for biologic products.

• Knowledge of pharmaceutical development, including drug substance, drug product and analytical methods.

• Demonstrated ability to develop/maintain strong working relationships with the regulatory CMC team and cross-functional teams, participate on and/or lead multifunctional teams, handle and prioritize multiple projects and work independently. 

• Ability to identify, communicate and resolve complex issues. 

• Prepare and manage filings and ensure thoroughness, accuracy and timeliness. 

Ability to interpret global regulations and guidance.
 

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.

Beschreibung der Position:

Als Medical Manager (m/w/d) für den Bereich Hematology & Oncology, GI Tumore, Melanom sind Sie Ansprechpartner für medizinisch-wissenschaftliche Fragestellungen in diesem Bereich. Sie sind verantwortlich für die Implementierung des Medical Plans. Sie konzipieren und überarbeiten wissenschaftliches (Werbe-) Material und gestalten die Produktkommunikation maßgeblich mit und führen regelmäßig medizinische Trainings durch. Sie unterstützen nach Bedarf Market Access bei der Erstellung aller Dokumente im Zusammenhang mit dem AMNOG Dossier. Zusammen mit der Klinischen Forschung unterstützen Sie lokale und internationale Studien. Auf lokaler sowie internationaler Ebene arbeiten Sie eng zusammen mit Marketing, dem Vertrieb, Market Access, Regulatory Sciences, Regional Clinical Operations, den Medical Science Liaisons und der Trainingsabteilung. Außerdem pflegen Sie den Kontakt zu wissenschaftlichen Meinungsbildnern und Prüfärzten und verfolgen die wichtigsten Kongresse.

Qualifikation für die Position:

Sie sind im Idealfall promovierter Arzt, Tierarzt, Apotheker oder Naturwissenschaftler und besitzen mehrjährige Berufserfahrung in Klinik oder der pharmazeutischen Industrie insbesondere im Bereich der soliden Onkologie. Die Vorbereitung neuer therapeutischer Gebiete und Anforderungen zur Einführung von neuen Medikamenten sind Ihnen vertraut. Sie haben bereits Erfahrung mit der Durchführung und Moderation von Advisory Boards, medizinischen Fortbildungen und ggf. der Mitarbeit an einem G-BA Verfahren zur Nutzenbewertung. Sie sind kundenorientiert, kennen die Stufen der Produktentwicklung und haben Erfahrung in der Gestaltung und Implementierung von klinischen Studien, ggf. Betreuung von ISRs und nicht-interventionellen Studien, sowie regulatorischen Abläufen. Sie sind kommunikativ und offen und präsentieren versiert wissenschaftliche Inhalte. Sie denken strategisch und zielorientiert. Ihre Kooperationsfähigkeit und Belastbarkeit zeichnen Sie aus. Sie sind ein Teamplayer und arbeiten effizient in Teamstrukturen des lokalen sowie internationalen Umfelds. Sie besitzen ausgezeichnete Englisch- und fundierte PC-Kenntnisse.

Befristung: befristet bis zum 31.12.2024

#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 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.

Position Summary
To coordinate and author documents needed for regulatory submissions, ensuring the coordination and integration of the scientific, medical, and regulatory input from cross-functional team members.

Key Responsibilities

• Coordinate and author regulatory documents [eg, Investigator’s Brochures (IB), development safety update reports, periodic benefit-risk evaluation reports, clinical study reports (CSR), protocols, and high-level summary documents] ensuring the coordination and integration of the scientific, medical, and regulatory input from development team members.

• Participate in relevant document subteam(s) and ensure effective planning and management of timelines for all components of assigned documents.

• Participate in document strategy sessions, including messaging, document flow, logic, and consistency for assigned projects.

• Maintain document prototypes and shells.

• Comply with internal and external processes and guidelines while managing the review process and, on an ongoing basis, resolve issues, errors, or inconsistencies with pertinent team members to ensure timely completion and high quality of assigned documents.

• Review and edit documents as required.

Qualifications & Experience

• PharmD/PhD in a relevant scientific discipline or Master's/bachelor's degree with at least 3-4 years of regulatory documentation. All PhD in biological sciences and PharmD candidates are considered.

• Demonstrated strong writing skills in authoring and managing the production of IB, Safety Aggregate Report, Clinical Protocols, and/or CSR.

• Ability to analyze and interpret complex data from a broad range of scientific disciplines.

• Understanding of global pharmaceutical drug development.

• Demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation, and interpersonal skills in a cross-functional team.

• Working knowledge of a document management system and basic knowledge of the document publishing process.

• Please note the position is not a remote working opportunity and is based in NJ.

#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.

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.

Manager, Digital Specimen Operations

Summary

We are developing a world-class Global Biospecimen and Imaging Management (GBSIM) organization within Global Development Operations (GDO) to drive excellence and innovation in end-to-end biospecimen and imaging management to support the objectives of both Research and Development. The operational oversight and management of the digital specimen strategy and lifecycle and precise vendor oversight to support these objectives is key. 

As such, we are recruiting for a Digital Specimen Operations Manager that will be responsible for providing project management, vendor oversight and operational support to the medical imaging component of multiple clinical trials across all therapeutic areas. Critical to this role is the ability to provide innovative solutions to oversee timelines for digital specimen data delivery and thereby, enabling quick decision-making and ensuring BMS’s continuous competitive advantage

As the GBSIM organization grows in scope and responsibility, primary responsibilities of this role may expand beyond medical imaging to include other digital specimen types.  Digital specimens are defined as a specimen, regardless of collection method that can be digitized to be viewed, analyzed, stored, indexed, and transmitted electronically.

Key Responsibilities and Major Duties of Digital Specimen Operations Manager:

• Tactical operations resource for clinical teams supporting the imaging strategy and imaging vendor selection.

• Interacts and liaises with imaging vendor project management teams and external imaging KOLs to enhance the value of the relationship and capabilities to BMS needs; ensuring BMS gets best-in class service from the imaging vendor/KOL on a global level.

• Interacts with imaging BMS protocol management teams; attends regular protocol related team meetings and responsible for communicating imaging timelines/needs

• Participates in protocol/imaging document development/review

• Provides operational guidance to clinical team and sites; clinical team training/education

• Ensures delivery of image data per pre-defined timelines and specifications

• Performs risk management and contributes to imaging issue resolution

• Supports due diligence efforts required to qualify imaging vendor, for participation in both novel and strategic BMS relationships requiring imaging capabilities

• Partners with the key stakeholders to develop and align BMS imaging standards

• Ensures program level processes and plans are developed to secure consistency across studies within an imaging paradigm

• Establishes trust and builds successful relationships with key internal and external stakeholders at all levels

• Through the use of effective communication practices, clarifies expectations, seeks to understand the needs of others and proactively provides status updates keeping stakeholders informed and up to date

• Proactively seeks feedback from stakeholders on the performance of self and team, operational processes and ways to optimize relationships

• Uses effective negotiation skills, diplomacy and tact and leverages those competencies to ensure continuous progress with the imaging vendor thus moving issues to resolution

• Applies broad business knowledge to ensure that decisions are taken in full context of BMS and the imaging vendor perspectives; ensuring balance between needs of the broader relationship vs. those of an individual team or function

• Fosters teamwork between BMS functional areas and imaging vendor; creating a team environment based on mutual trust and respect

• Encourages teams to share knowledge, experiences, best practices, and information on an ongoing basis and actively captures that knowledge for re-use and continuous improvement

• Willingness to travel (5-10% of time) to build relationships and review onsite capabilities

B.S., ideally with a concentration in a scientific or technical related discipline, and/or business/project management. PMP certification a plus.

Experience/Requirements

• Preferred experience:  5 years pharmaceutical and/or CRO project management experience

• Centralized medical imaging project management experience highly desired

• Digital Specimen Management (other than medical imaging) experience a plus.

• Demonstrated experience working with internal and external stakeholders (vendor management).

• Demonstrated ability to manage multiple protocols/projects simultaneously.

• Demonstrated ability to analyze and interpret complex problems/data from a variety of sources, and through effective decision-making and planning, deliver superior business results. 

• Knowledge of radiology response criteria used in oncology clinical trials preferred but not required (RECIST, etc.).

Competencies – knowledge, skills, abilities

• Strong written and verbal communication, presentation and organizational skills required.

• Ability to operate in a complex matrix organization.

• Must have a strong business partnering orientation with excellent analytic, interpersonal, and communication skill.

• Knowledge of ICH GCP and applicable local regulations governing clinical research along with basic medical and research knowledge.

• Experience with various imaging modalities incorporated and implemented in clinical trials for drug development preferred.

Excellent networking skills with proven track record in stakeholder and relationship management
#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.

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

Support the strategic and tactical planning as well as operational management of biospecimens, which contribute to asset development.  Our functional teams ensure timely availability of high quality, accurate, biological specimens; along with managing biospecimen information-driven by end-to-end visibility and best in class logistics.

Position Summary

No direct reports (this text for hiring requisitions only) 

Manager, Biospecimen Planning independent contributor who will work closely with our Clinical Teams to develop and implement biospecimen management plan for BMS-sponsored Phase 1-2a clinical trials and externally acquired biospecimens.  Members of this team will develop and execute asset and protocol-level biospecimen strategies initially under the guidance of senior colleagues and work across the organization and with BMS’s partners to implement and project manage efforts to execute these strategies. Critical to this role is the ability to provide innovative solutions to oversee timelines for specimen data delivery and thereby, enabling quick decision-making and ensuring BMS’s continuous competitive advantage. The individual will be responsible for supporting biospecimen management for the Early Development assets with opportunities to contribute toward optimizing work streams cross functionally throughout the organization as it relates to biospecimens.

Position Responsibilities

• Oversee and manage the complete lifecycle of biospecimens collected for early phase clinical studies with minimal supervision. 
• Core Clinical Team member responsible for providing Shipping/sample movement and management including requests, query and inventory reports, follow up active issues with vendors, prepare sample management related reports, review/prepare tracking activities (such as vendor manifests/inventories, tissue/blood match pairing, depleted/non-viable samples, loading documents to Shared Drive folders, etc.).
• Independently reviews clinical study protocol providing comparison of vendor statement of work and biospecimen relevant sections and feedback with support as needed.
• Performs routine vendor management responsibilities. Able to request and/or access necessary vendor/system inventory files to perform specimen tracking.
• Able, under direction, to create biospecimen tracker using various tracking tools (MS Excel, Spotfire, Tableau or Polaris (if applicable)) with support.
• Able to identify biospecimen related risks with support from risk library.  May require support for de novo risks and mitigation strategy proposals. Support Critical to Quality (C2Q) process with guidance, if needed.
• Exercises judgment within policy and procedure boundaries. Troubleshoots routine problems and understands when appropriate to ask for guidance. May need assistance to help prioritize BOW activities during critical deadlines.
• Maintain intermediate working knowledge of compound and study related biospecimen requirements.
• Ensure completion of individual Study Transition Forms

Degree Requirements

Scientific degree (Associates, Bachelors, Masters, or higher), Project management or equivalent experience.

Experience Requirements
 

Minimum of 2 years academic, biotech, healthcare or pharmaceutical industry experience or equivalent.

Basic understanding of clinical and biomedical research, GCP, GLP, CLIA, data and risk management.

Experience desired but not limited to: biospecimen life-cycle/operations, compliance, management and vendor management.

Key Competency Requirements

Demonstrated clinical trial experience, healthcare/medical/laboratory or equivalent.

Vendor experience preferred (e.g., Central Labs, Bioanalytical, Biomarker, CROs, Biospecimen Storage Vendors, etc.).

Ability to develop skills with training for stakeholder management including conflict and change management.

Biospecimen Operations Experience preferred but not mandatory.

Developing knowledge of the drug discovery or developmental process.

Applies Scientific and/or functional knowledge to conduct studies in assigned area.

Ability to effectively communicate, create and deliver presentation/information/data to knowledgeable audiences, with limited supervision.

Ability to adopt a biopharma enterprise-wide and entrepreneurial mindset, to act with a sense of urgency, accountability and integrity, and to have fun along the way.

Demonstrates change Agility through willingness to pivot current ways to working to new model(s)

#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.

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

The Specialist works cross-functionally to execute validation activities and prepare validation deliverables for S12 Enterprise Manufacturing Execution System (EMES) used in cell therapy manufacturing. This role is primarily an individual contributor but will routinely support project and production works. The Specialist will partner with site Business Owners, CI Owners, Quality, and the global EMES team to create, manage, and improve computerized systems/Recipes validation deliverables for electronic systems, applications, and associated controls to maintain data integrity supporting ALCOA+ principles throughout the CSV lifecycle. The Specialist will be responsible for ensuring the validation of the S12 Enterprise Manufacturing Execution System (EMES), and applications are done following the relevant BMS procedures, such as CSV SOP but no limited and applicable health authority regulations.

Responsibilities:

• Review & approve S12 MES Next Gen related qualification & validation documentation.
• Work with BO, MES IT, and QA to ensure that the site validation documentation is created, reviewed, and approved appropriately.
• Assist BO & MES IT in installing updated recipes and E-MES quailed recipe-related components (e.g., Operations, Behaviors, Interfaces, Equipment Classes, Reports, etc.) to the S12 site and verifying compliance with CSV.
• Work with QA to ensure CSV validation deliverables are prepared without compliance issues.
• Provide CSV & validation Production and Project support to S12 MES Next Gen.
• Complete all tasks required per the Change Management Process for S12 MES Next Gen SOP and in compliance with CSV and related SOPs.
• Review the summary reports from testing/validation to ensure all issues are resolved and approved.
• Ensuring that risks and issues impacting the validation strategy are resolved and mitigated.
• Assist UAT Test Script authoring, execution, and defects closure.
• Support IQ Test Script authoring, reviewing, and pre & post approvals of execution and defects closure.
• Author the verification/validation related documents (e.g., Validation/Test Plans, Requirements, Design / Configuration Specifications, Test Scripts [IQ/UAT], Summary Reports, Trace Matrices, SOPs, but not limited).
• Maintain the documents/testing trackers to support the needs of the Leader team.

Knowledge & Skills:

• Sound understanding of Electronic Batch Records (EBR) and Review by Exception (RBE) and Recipe Authoring/Validation.
• Ability to work extended hours or a modified work schedule to assist manufacturing operations support model, including 12x7 on-call support rotation.
• Knowledge of cGMP, GxP, GAMP, and SDLC regulations, including 21CFR part 11 electronic records and electronic signatures, and good documentation practices with the ALCOA+ principles of data integrity, risk-based approaches to validation, Computer Software Assurance (CSA) principles.
• Understanding the concept of Critical thinking for Computerized Systems.
• Familiar with the development of CSV documentation (Validation Plans, Requirements, Design / Configuration Specifications, Test Scripts [IQ/OQ/PQ/UAT], Summary Reports, Trace Matrices, SOPs).
• Experience with MES infrastructure, ALM and Veeva document/change management systems and middleware WebMethods.
• With advanced technical document writing and time management skills, including ability to prioritize and manage expectations.
• Operate effectively and with minimal supervision, within a team or independently, performing projects and related duties.

Basic Requirements:

• Bachelor's degree.
• Minimum of 2+ years relevant work experience.

Preferred Requirements:

• Bachelor's degree in a life sciences, engineering or technology discipline preferred.
• Minimum of 2+ years relevant work experience required preferably in a pharmaceutical manufacturing environment.
• An equivalent combination of education, experience and training may substitute.

 
Working Conditions:

• The incumbent will be required to work in an office environment, potentially requiring ergonomic considerations.
• The incumbent will be required to work in a conference room environment for moderate periods.
• The incumbent may be expected to work non-standard work hours, including weekends, to support high-priority project deadlines or emergency efforts impacting product delivery.
• The incumbent may travel between company sites for training, meetings, or corporate events on occasion.
• Occasional excursions to labs, production areas, or warehouses require some level of gowning.

BMSCART

VETERAN

#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.

Position Summary

The Senior Manager, Validation, Engineering and Technology is responsible for supporting the production of personalized cell therapy products for both global clinical trials and commercial supply at the Bristol Myers Squibb Manufacturing Plant (Jump), Bothell, WA. The Senior Manager oversees the Right to Operate, Operational Excellence and Ongoing Monitoring area within the Validation, Engineering & Technology (VET) team.

The Senior Manager will also oversee ad hoc teams performing VET activities, ensures the completion of all deliverables and develops the long term strategy of VET. Work will heavily involve the use and management of validation document control and quality system software and applications (e.g. ValGenesis, Infinity, Veeva Vault, Success Factors, BMRAM etc.), project plans and dashboards to drive accountability and delivery for the MSAT VET team.

This role will play a critical role in ensuring compliance with all regulatory requirements and industry standards related to GMP asset management and validation in a regulated GMP manufacturing facility. This position requires a hands-on leader with deep expertise in GMP, a thorough understanding of lab/manufacturing equipment, and a proven track record in validation processes.

Duties/Responsibilities

• Develop and execute validation plans for cGMP critical equipment and system with validation document deliverable in respect to cGMP, GDP, GXP, GAMP5 regulations, including 21CFR Part 11, computer system validation requirements, EU GMP Annex 15 principles and data integrity requirements.
• Act as a validation Subject Matter Expert (SME) providing support to multi-function teams, advises operations on validation matters, and potentially serves as the point of contact to present validation programs and strategies and defend their work before Health Authority inspectors and auditors.
• Lead/assist new facility and utility design, incorporation of new technology/processes/equipment, and/or upgrade current assets.
• Execute and/or lead multiple projects that require qualification work arising from change controls, risk assessment, capital projects, and ongoing supplemental validation deliverable per approved validation plans as a point of contact for project stakeholders and support GMP operations. On occasion, leads multiple technical teams and champions cross-functional projects and initiatives. 
• Work collaboratively with peers within the cross-functional teams (F&E, IT, MFG, QC, Supply Chain, and QA/QEV) to manage workload to address priorities, meet schedules, maximize productivity, reduce costs and COGM, and increase efficiencies.
• Build, maintain and leverage relationships across the matrix to identify opportunities for process improvement and facilitate the implementation of measurement and management systems.
• Regularly review, prioritize, and promptly respond to customer equipment qualification and support requests and maintain Jira system as part of the Agile methodology.
• Support GMSAT including our R&D site to execute validation related projects and make standardization across the sites. Develop and manage an ongoing monitoring program for GMP assets to ensure continued compliance and performance.
• Foster a culture of compliance, quality, and continuous improvement within the validation team.
• Interface with regulatory agencies during inspections and audits, serving as the subject matter expert for validation processes.
• Provide expert guidance and support to ensure that all validation processes and documentation meet regulatory expectations.
• Collaborate with cross-functional teams to address any findings related to validation and implement corrective actions as necessary.
• Oversee the qualification and validation of laboratory instruments, equipment, and systems, including but not limited to analytical instruments, autoclaves, and environmental monitoring systems.
• Implement risk-based validation approaches to optimize processes and reduce validation cycle times while maintaining the highest quality.
• Ensure all validation documentation, including protocols, test scripts, and reports, are accurately completed, reviewed, and archived in accordance with company policies.
• Routinely seek opportunities to learn BMS values. Excel in demonstrating one of the BMS values (Integrity, Innovation, Passion, Urgency, Inclusion, Accountability) and work to address perceived deficiencies.

Qualifications

• Bachelor’s Degree in life sciences/engineering/STEM or equivalent
• 8+ years of commissioning, qualification, and validation (CQV) experience within technical and regulated industries
• 4+ years of experience managing direct reports
• Expert knowledge of cGMP, GDP, GXP, GAMP5 regulations, including 21CFR part 11, computer systems validation requirements, EU GMP Annex 15, and data integrity requirements
• Experience with equipment/utility/facility qualifications and general commissioning, qualification and validation practices are required.
• Experience with investigations, deviations and CAPA management in a regulated pharmaceutical industry are required.
• Experience and in-depth understanding of validation lifecycle deliverables and documents from equipment design through qualification (starting with URS, to the end of IQ/OQ/PQ and SR) documents through system retirement.
• Excellent project and program management, communication skills, and technical writing skills are required.
• Knowledge and experience with electronic document management systems for quality record, procedural documents and validation lifecycle documents are desired.
• Possess the professionalism and technical competency required to represent the department before our customers, regulatory agencies, and management.
• Experience in the Pharma/Biopharma required, cell therapy industry is plus.
• Detail oriented, with strong GMP, Validation and Engineering experience
• Experience utilizing regulatory knowledge to drive innovation and improvement in validation and engineering functions.
• Lean and Six Sigma experience is desirable

The starting compensation for this job is a range from $114,000 - $144,000, plus incentive cash and stock opportunities (based on eligibility).

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

For more on benefits, please visit our BMS Careers site.

Eligibility for specific benefits listed in our careers site may vary based on the job and location.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

TRAVEL REQUIREMENTS:

☐ Not Applicable-NA

Infrequent visits to other BMS Cell Therapy sites and the Seattle, WA facility may be required.

WORKING CONDITIONS (US Only):

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 within reason.

BMSCART VETERAN

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

Position: Executive Director, Worldwide Medical NeuroPsychiatry Medical Communications

Location: Princeton, New Jersey

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.       

We are seeking a NeuroPsychiatry Medical Communications Executive leader with a deep understanding of disease states, medical education, scientific customer experience and communication within NeuroPsychiatry. In this exciting role you will create scientific communication strategic plans, publication tactics, field medical educational material and external communication tools in alignment with the business needs within Medical Affairs and Clinical Development.

The core purpose of this role is to help shape the enterprise Medical Communications and Customer experience strategies and to drive the NeuroPsychiatry integrated scientific communications through effective delivery, as well as supporting the end-to-end campaign execution in close collaboration with Commercial and Development. He/she will be expected to be a subject matter and data expert, as well as an expert in communications principles and execution to ensure that the team communicates company science and data to the right audiences, at the right time through the most relevant channels with success demonstrated both quantitatively and qualitatively.

Key Responsibilities

The ideal candidate of the team will have an outstanding level of desire to lead people with a strong leadership track record of creating/leading/transforming teams. He/she will be an impact player to drive quality and fast impact. He/she will carry a growth mindset, reflected through maximization of the opportunity to reach more patients and an immense sense of urgency for strategy and execution.

• Chairs Scientific Communications matrix team overseeing development of materials for NeuroPsychiatry specific assets in accordance with the asset specific strategy.
• Develops a high performing Medical Communications team focus to support the development and launch of NeuroPsychiatry assets
• Key representative member of the NeuroPsychiatry LT.
• Provides strategically aligned (with the Brand Lead and the GPL) scientific communication and publication plans for company assets
• Create simultaneous and aligned enduring materials and educational activities
• Accountable for accurate and impactful scientific deliverables including publications, symposia, slide decks, MSL tools, and booth materials and accuracy review of non-departmental driven materials (e.g. MI letters) as well independent medical Education (IME)
• For all deliverables, collaborates with investigators, congresses, medical experts and will liaise with cross functional internal team including clinical development, medical, marketing and biostatistics
• Oversees the development of scientific platforms for NeuroPsychiatry specific assets
• Assists in the development and execution of innovative tools for internal and external communication including digital/omnichannel/social media delivery
• Delivers timely execution for all deliverables within the Medical Communications plans for assigned assets
• Leads asset specific publication, scientific engagement and medical education/IME standards globally
• Oversees medical education strategy for assigned assets exploring innovative and interactive educational opportunities and executing on educational symposia at congresses as needed
• Disseminates internally up to date scientific data across NeuroPsychiatry assets and disease states including recent publications, landscape, insights, presentations, study specific information, scientific statements, providing training as needed to medical affairs associates
• ensures awareness of TA specific assets internally by developing materials and training tools
• Ensures clinical trial awareness materials available to MSLs to supplement trial recruitment activities
• Maximizes medical communication opportunity through the creation of tools and content for advisory boards, medical booths and externally facing meetings as needed
• Owner of budget and vendor management

Qualifications & Experience

• Basic qualifications
  • PhD, PharmD, or MD
  • 10+ years TA specific experience mandatory (pharmaceutical company or communications agency)
  • 5+ years direct line management experience mandatory
  • Experience in developing TA specific medical education tools and materials
  • Knowledge of publication guidelines and practices
  • Ability to interpret, analyze and organize scientific data
  • Experience with strategic and tactical publication planning, development of abstracts, manuscripts, and slide decks with strong scientific content
  • Experience with medical education meetings and digital/omnichannel/social media delivery
  • Experience with Budget and Vendor management
  • Experience leading and working within cross functional teams
• Preferred qualifications
  • Strong organizational, planning, and business acumen skills
  • Ability to prioritize business needs and flexibility to address them when business appropriate
  • Ability to conceptually organize and analyze data; interpret and synthesize complex clinical and non-clinical statistical reports to derive key outcomes and messages; ability to translate scientific and technical issues for diverse audience
  • 5+ years od Experience or background in working within the pharmaceutical industry, strong awareness of compliance issues and guidelines around medical education and publications
  • Ability to work with multidisciplinary teams to ensure execution of deliverables successfully
  • Prioritize projects effectively and proactively collaborate and communicate at all levels within the company
  • Experience with innovative tools and electronic communications channels; knowledge of applicable guidance related to the dissemination of scientific evidence to external customers
  • Strong leadership capability with a focus on development of high performing, diverse, integrated teams
  • Expertise in collaborating with external experts on medical affairs activities
  • Princeton, NJ based

Why You Should Apply

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

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

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

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

Incumbent into the position must reside in the territory advertised.

This territory includes: Philadelphia and the surrounding suburbs, Central and Southern New Jersey

As part of the commercial organization, the Clinical Nurse Consultant (CNC) is a trusted clinical expert responsible for developing professional relationships and educating key Health Care Professionals (HCP) involved in the care of patients receiving BMS hematology products in a defined geography.

• The primary role of the CNC is to drive peer to peer interactions with customers that optimize patient outcomes by delivering end-to-end clinical exchanges that clarify the complexities of patient identification and management.

• The purpose of these interactions is to deliver a continuum of clinical education and support that address the needs of HCPs starting or continuing patients on BMS hematology medicines, optimizing patient management and duration of treatment.  CNCs also educate on unmet disease needs and discuss the current treatment landscape for these patient populations.  CNC interactions are aligned with on-label commercial strategies and the needs expressed by customers. 

• CNCs develop relationships with hematology focused Patient Support Groups for the purpose of presenting approved presentations that address specific patient education needs identified by the group leader.

• CNCs are viewed as clinical experts by their customers for the BMS hematology portfolio and are responsible for REBLOZYL (MDS), ONUREG (AML), POMALYST & REVLIMID (MM), ABECMA & BREYANZI (CAR-T).  Product responsibilities may change based on franchise and business needs.

Customer Focus

• Develop and maintain relationships with academic and community HCPs within assigned geography to provide on-label clinical and product education for BMS hematology products. The CNC will use various channels for interactions (1:1, group presentations, remote, etc.) while utilizing on-label approved marketing materials.

• Actively assess the treatment and patient management landscape by meeting with HCPs to understand their needs and current patient management processes/protocols.

• Demonstrate proficiency in using available on-label CNC resources and presentations. Effectively utilize platform skills for presenting information to HCPs and be able to respond to questions, ensuring accuracy and compliance with local procedures, ethical and legal guidelines and directives.

• Consistently evaluate the impact of CNC activities in an account and plan for follow-up or next steps.

• Respond and adapt quickly to support new and ongoing educational gaps or other customer needs.

• Actively monitor CNC dashboard & account data, adjusting activities and business plans to meet goals and objectives.

• Continuously seek to increase knowledge of treatment landscape, product attributes and disease states. Actively prepare to address the educational needs of customers.

Provide Clinical Expertise

• In collaboration with sales partners, deliver on-label promotional speaker programs to HCP customers in approved out of office settings.

• In collaboration with sales partners, deliver on-label promotional in-services for HCP customers.

• Provide product demonstrations and infusion support for CAR T sites starting new patients. 

• Support initial and ongoing clinical/disease area and product specific training to internal stakeholders (e.g. Commercial, Value Access & Payment).

• Participate in assigned Medical Congress activities.

• Share clinical insights and patient management experiences internally to support franchise strategy.  

Commercial Planning and Execution

• Adopt account business planning approach and contribute to cross-functional business plans.

• Collaborate with peers and cross-functional partners to successfully execute Hematology franchise performance goals and metrics. 

• Assist with the development of clinically meaningful CNC programs/projects in line with commercial strategies and plans.

Required Qualifications and Experience

• APP (DNP, NP, PA), MSN, BSN with a minimum of 5 years clinical experience in a Hematology/Oncology Disease Area.

• Nurse Educator experience within the bio/pharmaceutical industry preferred

• Current active Nursing or PA licensure

• Clinical depth within Hematology and Cell Therapy including AML, Lymphoma, MDS, and Myeloma

Behaviors and Competencies Desired:

• Strong business acumen that leads to plans and execution aligned with business priorities

• Advanced impactful communication skills, including effective presentation platform skills

• Experience effectively transferring clinical expertise to others and influencing patient management processes/protocols

• Collaboration skills that lead to meaningful partnerships with other internal functions

• Established relationships with health care providers within assigned geography

• Demonstrates BMS Values

Essential Qualifications

• This field-based role requires frequent travel (approximately 50-75% of time) and HCP interactions in multiple public settings. Candidates must be willing and able to fly and drive within and out of their territory to meet business needs.

• A company car is provided and candidates must have a valid state-issued driver’s license and clear driving record.

• Candidates must have the ability to work nights & weekends as needed. 

• Candidates must operate in compliance with all laws, regulations, and policies.

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.

Locations

Philadelphia and surrounding area, Central and Southern New Jersey

Compensation Grade

EG-120

On-site Protocol
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

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.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

The Associate Director, External Partners & Research position will play a critical role in driving standardization, continuous improvement, and reducing demand within Agile Sourcing Function. This will be a new capability within Sourcing Excellence. The candidate will need to be comfortable with leading change and taking calculated risk. This role will support the Research Categories for Source to Contract execution, global category strategies and manage external partnerships vital to our source to contract delivery model. The Associate Director will lead a team of resources and outsourced providers, ensuring effective sourcing, negotiating, contracting, and purchasing activities to optimize buying power and achieve desired procurement outcomes.

Major Responsibilities and Accountabilities:

Performance Management & Continuous Improvement Source to Contract

• Establish Best Practices for Source to Contract Operations.

• Work with Agile Sourcing LT to create and monitor operational standards & maintain performance standards.

• Review Team Performance, Compliance & Identify Trends for Continuous Improvement to improve operational effectiveness.

• Lead Cross functional team to implement continuous improvement programs.

• Serve as an advisor for functional leads to identify trends and resolve operational gaps within the team.

• Work across procurement and with the law department to find improvements to contracting process, recommend updates to contract templates, collect fallback language, and develop guidance for negotiations.

• Coordinate support for Health Authority Inspections and M&A Activity.

Oversee end-to-end development and implementation of Sourcing Strategy and Contracting for Research:

• Guide and support functional teams to establish procurement plans that are developed and executed in congruence with organizational objectives and sourcing strategies.

• Act as a trusted advisor to global category managers and their leadership to ensure procurement strategies can be delivered against the expectations of the business.

• Oversee the development and execution of sourcing events and proposals with pertinent specifications, terms, and conditions.

• Guide teams to evaluate and execute competitive offerings to determine the overall best offer for a product or service, negotiating contracts, obtaining legal review and approval, facilitating, and issuing contracts, and leveraging BPO partners to support facilitation/administration of contracts where appropriate.

• Ensure negotiated terms are translated into contractual terms, following BMS templates provided by Legal Department, and work in close partnership with BMS Lawyers when needed.

Provide oversight and supplier management for external providers

• Provide Program oversight for external providers of source to contract support.

• Conduct operational reviews and coordinate with internal customers for Supplier Management program. Coordinate feedback on performance and delivery models for continuous improvement.

• Oversee compliance programs, ensure compliance, and risk responsibilities are appropriately staffed and training conducted

• Accountable for projects and their full compliance with BMS policies and external regulations/laws, including FCPA, FDA, EMA, SOX, Sunshine Act, and others).

Qualifications

Minimum Requirements

• Minimum education of an Undergraduate Degree preferably in Supply Chain Management, Business management, Life Sciences, or Pharmaceutical.

• Minimum of seven (7) years of business experience in which two (2) to four (4) years are multi-disciplined procurement experience.

• Minimum of three (3) years of experience managing a direct team, with ability to manage large group of professionals. Hands on manager, who provides close leadership and support to his/her team.

• Experience leading and participating on cross-functional and/or global teams.

• Strong contracting acumen.

• Relevant Research Category sourcing experience.

• Procurement process knowledge, agreement management, financial analysis, market analysis, supplier analysis, supplier diversity, supplier management, technology utilization, strategic planning, and integrated supply chain experience.

#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.