Job Search Results
Drug Discovery Research
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 Oncology Thematic Research Center at BMS is a key research and early development engine, responsible for the discovery and development of novel oncology therapeutics for patients. Centered at our state-of-the-art research sites in Cambridge and Seattle, scientists focus on novel targets and pathways for tumors that are refractory to current therapies. With a deep understanding of the causal human biology, we are able to leverage our multiple modality platforms to best match the modality to the mechanism and desired outcome. We are a fully integrated drug discovery through translational and early clinical development organization which exploits state-of-the-art in vitro, in vivo and ex-vivo models of Cancer biology and Immuno-oncology to identify and validate targets. We partner closely with colleagues in Translational Medicine, Informatics and Predictive Sciences and Early Clinical Development to generate biomarker and patient enrichment hypotheses to enable efficient decision making in early clinical trials. We are optimally positioned to complement the world-class translational expertise, biology and leading academic research centers in the area.
Our Bristol Myers Squibb research site in Cambridge Crossing will help us continue to deliver on our mission, positioning the company and our scientists in the heart of a vibrant ecosystem of world-class science, innovation, and business opportunities.
Position Summary:
This is an exciting opportunity to develop and execute on a strategy to identify and advance our understanding of cancer immunology and tumor cell extrinsic targets by applying functional genomics to interrogate patient-relevant disease models (cell lines, organoids (PDO), PDX). The successful applicant will lead a team to use cutting-edge techniques to generate biological, mechanistic, and structural insights that support target rationale. The candidate will be expected to collaborate effectively with colleagues within Discovery Oncology and across the BMS enterprise, including Drug Discovery, Translational Research, Informatics and Predictive Sciences, and the Discovery and Development Sciences groups.
Position Responsibilities:
In the role as a Principal Scientist within Discovery BioSciences, the ideal candidate:
Will be responsible for the discovery of next-generation oncology biotherapeutic targets (eg. ADCs, multispecifics, and TCEs) utilizing molecular biology and genome engineering techniques in disease relevant pre-clinical models. The role requires extensive knowledge in how to functionally interrogate biotherapeutics-based mechanisms and modalities including screen conceptualization, design, and execution.
Effective management skills with a track record of leading effective teams
Proven ability to strategize, develop, and articulate concepts
Work across teams, externally interface, with good communication skills
Strong biology skills with experience using a wide range of cellular and molecular biology techniques, cell culture and manipulation of complex cellular model systems (organoid, immune and stromal cell co-culture, and cancer cells), flow cytometry, qPCR, cell proliferation assays, generating reporter assays, molecular cloning techniques, western blotting, immunoprecipitation, ELISA
Strong experience developing and applying state-of-the-art gene perturbation methods (siRNA/shRNA knockdown and CRISPR-mediated genome editing) and/or variant screening (deep mutational scanning, base-editing). Experience with ex vivo pharmacology including model generation and optimization is strongly preferred.
Excellent interpersonal skills with the ability to work in a matrixed environment, interacting with colleagues across functions including translational research, in vitro pharmacology, and drug discovery.
Ability to interface with computational biologists and AI/ML experts to deploy appropriate analyses methodologies is required
An ability to mine large-scale genetic screen datasets using desktop tools/interfaces, AI integration, and public databases (CBIO, DepMap, TCGA, CCLE, Genepattern etc.) for target hypothesis generation is strongly desired.
Proficiency in utilizing software such as Benchling, GraphPad, FlowJo, Microsoft Office, Spotfire, JIRA, Confluence etc. for experimental design, data analyses, tracking, and figure generation is highly desired.
Experience =
Basic Qualifications:
Bachelor’s Degree
8+ years of academic and / or industry experience
Or
Master’s Degree
6+ years of academic and / or industry experience
Or
Ph.D. or equivalent advanced degree in the Life Sciences
4+ years of academic and / or industry experience
Preferred Qualifications:
PhD with 4+ years of academic/industry experience in Oncology, with background in cancer immunology and/or exploration of tumor extrinsic mechanisms is strongly preferred.
Experienced in the design and development of cell-based viability and reporter assays using various technology platforms, especially gene perturbation to assess viability, imaging, and signaling pathway phenotypes in organoid or tumoroid, and 2D cultures.
Experience developing molecular biology assays, cell culture, and analyses of protein and DNA/RNA samples using a variety of methodologies including but not limited to: vector cloning, flow cytometry, RNAi, CRISPR-Cas, Cas activity assays (reporter and genomics readouts), qPCR, ex-vivo culturing, co-culture assays, functional and imaging-based readouts, lentiviral production and transduction, electroporation.
Effectively troubleshooting skills when optimizing assays and when developing innovative methodologies.
Ability to efficiently manage and prioritize multiple projects, coordinating in-house research with collaborative work.
Ability to summarize and interpret scientific data in a clear, concise, and accurate manner.
Excellent oral and written communication skills. Ability to communicate and discuss data with peers and supervisors.
Ability to work alongside colleagues in a team environment.
Exceptional organizational skills and meticulous attention to detail
Strong problem-solving skills and understanding of relevant scientific principles.
#LI-Onsite
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Clinical Development
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.
Director, Early Clinical Development (MD) – Hematology & Cell Therapy with Focus in Cellular Therapy for Autoimmune Indications
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. The Early Clinical Development (ECD-HOCT) team at BMS is responsible for hematology, oncology and cell therapy (including diverse indications spanning oncology, hematology, rheumatology, immunology, neurology, etc.) pipeline assets and sits at the interface between discovery and translational science and clinical drug development.
The Director, Early Clinical Development role will focus on the emerging and rapidly expanding area of cellular therapy for autoimmune indications. Physician-scientists and clinical-scientists within this group oversee the early development of both internal and partnered assets covering all cellular therapy platforms for autoimmune conditions. Therapeutic areas span the full range of autoimmune disorders, including hematology, rheumatology, and neurology. The ECD-HOCT team interacts hand-in-glove with discovery and translational scientists, project leadership, late development and commercial colleagues to optimize biomarker, patient enrichment, and dosing strategies to enable faster and more effective drug development informed by core scientific principles and data.
Functional Area Description
The Early Clinical Development - HOCT function is part of a global organization dedicated to the effective design and execution of early drug development. Early Clinical Development drives clinical development strategy, design, execution, and interpretation of clinical trials.
Position Summary / Objective
- Serves as a primary source of medical accountability and oversight for multiple clinical trials
- Manages Phase I/II studies, with demonstrated decision making capabilities
- Provides medical and scientific expertise to cross-functional BMS colleagues
- Maintains matrix management responsibilities across internal and external networks
Position Responsibilities
Medical Monitoring
- Independent medical monitor for clinical trials from Phase 1 through Proof-of-Concept by
- Articulating clinical development strategy
- Analyzing, interpreting, and acting on Clinical Trial data to support development, and
- Serving as principal functional author for Regulatory submission, study reports, and publications
- Provides oversight and medical accountability for multiple trials across early development clinical lifecycle
- Manages site interactions in partnership with the Clinical Scientist (CS) for medical questions and education (including safety management guidelines)
- Assesses key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversees safety narratives
- Contributes to and is a key member of a high performing Study Delivery Team (SDT) and may be a member of the Development Team
- Collaborates with CS and provides input into protocols, contributing medical strategic oversight in protocol development (input on inclusion/exclusion and other safety-related clinical considerations)
- Fulfills GCP and compliance obligations for clinical conduct and maintains all required training
- Acts as a focal point for defining and establishing relationships with key global Phase I Centers
- Works on multiple trials across early development clinical lifecycle.
Clinical Development Expertise & Strategy
- Designs and develops clinical studies and research plans in support of asset strategy with the Early Clinical Development Leadership team; Clinical studies include first-in-human Phase I, proof of concept Phase I/II, entry registrational studies, and/or clinical pharmacology studies
- Liaises with Clinical Scientists, Translational & Discovery Scientists and Development Teams to define dose and schedule, indications, and patient selection (e.g., biomarker qualification and implementation)
- Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment working with Clinical Scientists
- Partners with CS to support executional delivery of studies (e.g., site activation, enrollment status, as well as adjudication for protocol violations, significant, non-significant deviations etc.)
- Maintains a strong medical/scientific reputation within the disease area; has in-depth knowledge of etiology, natural history, diagnosis, and treatment of the disorder
- Keeps up to date in the disease area by attending scientific conferences and ongoing review of the literature
- Keeps abreast of development and regulatory issues related to other competitive or relevant compounds in development and how our portfolio fits into the competitive landscape
- Provides ongoing medical education in partnership with CS to allow for protocol-specific training, supporting the study team, investigators, and others
- Ad-Hoc involvement in various departmental initiatives (e.g., committees, sub-teams etc.)
- Presents and/or articulates clinical strategy to senior leadership and to support progression of portfolio
Health Authority Interactions
- Contributes to key Health Authority interactions and advisory board meetings as Early Clinical Development Physician; serves as Primary Clinical Representative in Regulatory interactions for early development projects
- Authors/drafts clinical content for CSRs, regulatory reports, briefing books and submission documents to support closure, clinical narratives, reporting and filling of the study in partnership with Clinical Scientists
External Partnerships, Alliances, and Publications
- Sits on team responsible for establishing key alliances with academic centers, co-operative groups, vendors and government agencies
- Represents department in business development due diligence and partner alliance management with oversight
- Acts as a focal point for defining and establishing relationships with key global Phase 1 Centers
- Track record or recognized for contributions to field (e.g., publications, patents, keynote participation in conferences etc.)
Degree Requirements
- Advanced degree(s) in relevant field: MD, MD/PhD (or x-US equivalent) and clinical expertise in a therapeutic area (e.g., attending level or international equivalent)
- Subspecialty fellowship training in rheumatology or hematology area preferred
Experience Requirements
- 5+ years of relevant experience in discovery, translational and/or clinical research in academic or industry setting including education where applicable
- Clinical trial leadership experience (e.g., study director, etc.) within pharmaceutical industry preferred OR
- Significant independent clinical/laboratory/translational research experience in academic/pharmaceutical setting preferred including demonstrable achievement in experimental design, interpretation and exposition
Key Competency Requirements
- Ability to communicate and present information clearly in scientific and clinical settings
- Expertise in the scientific method to test hypotheses, including statistical design, analysis, and interpretation
- Knowledge of drug development process
- Knowledge of the components needed to execute an effective clinical plan and protocols
- Strong leadership skills with proven ability to lead and work effectively in a team environment
The starting compensation for this job is a range from $275,630-374,100, plus incentive cash and stock opportunities (based on eligibility).
The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.
Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Information Technology
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:
This position serves as a sub-team lead or senior individual contributor on the Process Automation Team within Devens Cell Therapy. The role is focused on, but not limited to, operational support of the Process Automation Systems.
Duties/Responsibilities:
Function as a DeltaV, PI, and Building Automation System Subject Matter Expert and System Administrator for multiple systems to support the operation of all GMP and non-GMP control systems and other auxiliary equipment at the Devens Cell Therapy Facility.
Member of a team of automation engineers that investigate, design, configure/integrate, and test process control solutions to a variety of complex technical problems.
Member of cross-functional teams that develop requirements and perform qualification and validation activities.
Provide troubleshooting and guidance support to automation systems in support of Manufacturing as part of daily responsibilities and a 24/7 on-call rotation.
Exercise sound judgment in making decisions and recommendations within generally defined practices and policies and notify senior management when necessary.
Monitor and support the delivery of automation team deliverables and function as the application system owner for automation systems.
Reporting Relationship:
This position reports to the Automation Systems Lead at the Cell Therapy Facility, Devens, MA.
Required Experience:
Experience with DeltaV, PI, and OT Infrastructure.
Understanding of S88, S95, and batch processing operations.
Understanding of engineering documentation such as P&IDs, network diagrams, process flow diagrams, and SOPs.
Understanding of Validation Lifecycle Management, including the planning, creation, and execution of IQ’s, OQ’s, and PQ’s.
Ability to establish and maintain professional relationships across cross-functional teams.
Experience with QMS systems (Veeva, or similar) and GMP Quality Processes (Deviation Management, Change Controls, etc.) required.
Ability to troubleshoot network and control systems from the field element up through operator interfaces and databases.
Experience with IT Ticketing Systems (ServiceNow or similar).
Excellent communication skills including oral, written, and formal presentations.
Ability to clearly communicate technical information to a variety of audiences.
Preferred Experience:
Experience with Control System Networking Technologies and PC networking technologies.
Experience working with SQL, Server, Oracle, or other relational databases.
Experience with Validation Lifecycle Management Systems (Valgenesis, or similar).
Experience with Building Automation Systems.
Experience with .Net scripting.
Education/Experience/ Licenses/Certifications:
Bachelor’s degree in engineering or its equivalent.
Specific technical skills with 4-7 years’ experience working with control systems (DeltaV, PI, BAS and PLC's) in the Pharmaceutical or Biotechnology sector.
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Information Technology
Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.
Summary:
We are seeking a highly skilled and motivated Computer System Validation (CSV) Engineer to join our team at Devens Cell Therapy Facility. The CSV Engineer will be responsible for ensuring that all computer systems and software used in our manufacturing and laboratory environments comply with regulatory requirements and industry standards. This role involves the development, execution, and maintenance of validation protocols and documentation to support the validation lifecycle of GxP systems.
Key Responsibilities:
Develop and execute validation plans, protocols (IQ, OQ, PQ), and reports for computer systems and software applications used in GxP environments.
Ensure compliance with regulatory requirements (FDA, EMA, etc.) and industry standards (GAMP 5, 21 CFR Part 11, etc.).
Collaborate with cross-functional teams, including IT, Manufacturing Sciences and Technology, Quality Assurance, Manufacturing, and Laboratory, to ensure successful validation of systems.
Perform risk assessments and impact analyses to determine the validation requirements for new and existing systems.
Maintain validation documentation and ensure it is up-to-date and readily available for audits and inspections.
Participate in the review and approval of system change controls, deviations, and CAPAs related to computer systems.
Provide training and guidance to stakeholders on CSV processes and best practices.
Stay current with industry trends and regulatory updates related to computer system validation.
Qualifications:
Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related field.
Minimum of 2 years of experience in computer system validation within the pharmaceutical, biotechnology, or medical device industry.
Strong knowledge of regulatory requirements and industry standards related to CSV (e.g., FDA, EMA, GAMP 5, 21 CFR Part 11).
Experience with validation of various types of systems, including MES, DeltaV, LIMS, ERP, and laboratory instruments.
Excellent written and verbal communication skills, with the ability to create clear and concise validation documentation.
Strong analytical and problem-solving skills, with attention to detail.
Ability to work independently and as part of a team in a fast-paced environment.
Proficiency in Microsoft Office Suite and validation software tools.
Preferred Qualifications:
Advanced degree in a related field.
Experience with cloud-based systems and software as a service (SaaS) validation.
Knowledge of data integrity principles and practices.
Certification in computer system validation or related areas (e.g., ASQ, ISPE).
Working Conditions:
Office and laboratory environment.
Occasional travel may be required to support validation activities and workshops at other sites.
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Information Technology
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 Engineer – IT Compliance, Cell Therapy at Devens Cell Therapy Facility (CTF) will support the development, implementation, and maintenance of IT/Automation (Digital Plant) processes and ensure the group’s adherence to System Life Cycle standards. This role will primarily support the IT Compliance, IT Deviation Management, Computer System Audit, Change Management, Training Management, and the Risk Management Programs at the Devens CTF.
Duties/Responsibilities:
Supports IT Compliance, IT Deviation Management Program, Computer System Audit, Change Management, Training Management, and Risk Management Programs at the Devens CTF.
Acts as a CSV Subject Matter Expert (SME) for computerized system related changes and associated IT/Automation projects. This may include developing and executing validation plans, protocols (IQ, OQ, PQ), and reports for computer systems and software applications used in GxP environments.
Collaborates with cross-functional teams, including IT, Manufacturing Sciences and Technology, Quality Assurance, Manufacturing, and Laboratory, to ensure successful validation of systems.
Supports regulatory audits and internal audits as a Digital Plant representative, responsible for inspections readiness and finding responses.
Interacts with Veeva Vault (Quality Management System) to enter deviations and associated actions, investigations and associated root cause analysis, supporting data, corrective action/preventative action (CAPA) and effectiveness checks as needed.
Provides IT compliance support to Devens CTF Digital Plant team through owning or supporting investigations and change controls, deviation ownership of computerized system events, and CSV activities.
Provides support to maintaining quality system compliance against established KPIs for the Devens CTF Digital Plant team
Provides compliance support of Digital Plant programs and system maintenance activities.
Ensures that Digital Plant standard operating procedures (SOPs) and procedural methodologies employed to maintain the validated state are regularly reviewed and updated, as needed.
Reporting Relationship:
This position will report into the Devens CTF Site Sr. Manager of IT Quality and Compliance
Qualifications:
Strong knowledge of regulatory requirements and industry standards related to computer system validation (CSV) requirements (e.g., FDA, EMA, GAMP 5, 21 CFR Part 11, Annex 11) as they apply to Cell & Gene Therapy or Biologics manufacturing.
Experience with Quality principles and QA methodologies, including ISO 9001 and ICH guidelines (e.g., Q7, Q9, Q10).
Experience working with global policies/procedures, CGMP requirements, and regulatory guidelines, demonstrating the ability to work within a regulated environment for a fully automated, multi-product, Cell Therapy manufacturing facility.
Experience in implementing and supporting quality systems including risk management, audit readiness, deviation management, training management, and change management programs.
Strong in project management, verbal communication, and technical writing skills.
Proficiency using electronic quality management systems, such as Veeva Vault Quality.
Knowledge of data integrity principles and practices.
Preferred Qualifications:
Experience working with Manufacturing Execution Systems (Syncade), Process Automation Systems (DeltaV), and Benchtop IT Systems.
Experience with Lean Six Sigma and Operational Excellence.
Experience developing and applying new and innovative approaches to projects and processes.
Education/Experience/Licenses/Certifications:
Engineering and science experience generally attained through studies resulting in a B.S. in Engineering, Sciences, or a related IT/OT discipline or its equivalent.
A minimum of 2 years of the above relevant experience preferably in the Cell Therapy or life sciences area is required.
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Clinical Development
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 Clinical Scientist function provides scientific expertise necessary to design and deliver clinical studies and programs.
Position Summary / Objective
• Will be responsible for design and execution of assigned clinical trial activities and work closely with clinical team members within the assigned project to execute activities associated with the conduct
• May serve as Clinical Trial Lead for one or more trials
• May lead or support trial level activities for one or more trials with the necessary supervision
• May co-lead study team meetings in partnership with GDO protocol manager and collaborate with cross-functional study team members
Position Responsibilities
• Collaborate and liaise with external partners (e.g., KOLs)
• Seek out and enact best practices with instruction
• Provide regular and timely updates to manager/management as requested
• Develop Protocol and ICF documents / amendments and present these to governance committee and development team meetings as required
• Conduct literature review
• Submit clinical documents to TMF
• Develop site and CRA training materials and present these at SIVs and Investigator meetings
• Review clinical narratives
• Monitor clinical data for specific trends
• Develop Data Review Plan in collaboration with Data Management
• Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming
• Submit clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission.)
Degree Requirements
Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred). Appropriate for new entrance to pharma (post fellowship/ new to industry)
Experience Requirements
• Basic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
• Ability to understand assigned protocol(s) and their requirements
• Basic knowledge skills to support program-specific data review and trend identification
• Intermediate medical writing skills and medical terminology
• Basic planning/project management skills (develop short range plans that are realistic and effective)
Travel Required
Domestic and International travel may be required.
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Clinical Development
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 inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, cell therapy, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Position Summary
The Associate Director of Biostatistics is a member of cross-functional Development teams and contributes to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions. With appropriate experience, the Associate Director of Biostatistics can have responsibilities for supporting a particular indication of an asset. These individuals develop collaborative relationships and work effectively with the Biostatistics indication/asset Lead, and other cross functional team members.
Key Responsibilities
- Collaborates in design of innovative and efficient clinical trials, including the selection of study population/endpoints to address study objectives, and contributes to project development strategy
- Defends protocols and analysis plans at internal governance reviews and provides independent reviews of complex protocols.
- Independently authors and/or reviews protocol, statistical analysis plan, clinical study reports, associated publications, and other study level documents
- Presents summary data and analyses results, in a clear, concise, complete, and transparent manner
- Provides statistical support and leadership to address health authority request, publication, presentation, and other public release of information
- Manages multiple studies to ensure consistency and adherence to standards within an indication or therapeutic area
- Applies extensive knowledge of statistical / clinical trials methodology as it relates to clinical development
- Invests in developing knowledge outside of traditional statistical expertise in the clinical, regulatory and commercial environments with demonstrated application to study design.
- Effectively engages as a matrix team member on project teams, to act as a scientific and strategic partner in the drug development process
- Compliant with BMS processes and SOPs, adherence to global and project standards within an indication or therapeutic area and responsible for quality of deliverable
- Contributes to external and internal statistical community of practice
- Develops & advises team members
- Effectively communicates the GBDS Mission and Vision in a fashion that generates pride, excitement and commitment within GBDS.
- Enables a culture of inclusiveness, respect for diversity, compliance with process and allows for the questioning and challenging of others in a respectful and constructive manner.
Applicable to people managers
- Effectively engages as an employee advocate and management coach/mentor to team members - both internally and externally
- Provides leadership to empower and develop the team.
- Provides guidance to employee's development plans and carries out performance review and feedback. develops performance metrics for staff.
Qualifications & Experience
- PhD (6+ years’ experience) or MS (8+ years’ experience) in statistics or biostatistics or related scientific field with clinical trials, drug development, pharmaceutical industry or healthcare experience
- Proficiency in scientific computing/programming (SAS, R or Python) and implementation of advanced statistical analysis, data manipulation, graphing & simulation.
- Great interpersonal, communication, writing and organizational skills
- Expertise in statistical/clinical trials methodology as it related to clinical development and ability to apply to relevant clinical development framework
- Good understanding of regulatory landscape and experience with participating in regulatory interactions
- Demonstrate collaboration, organizational/ leadership abilities, and interpersonal skills
- Demonstrate ability to plan, organize, and prioritize multiple work assignments, and strong project management skills
- People manager experience is preferred (for people manager position only)
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.
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Information Technology
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.
Description: DevEx Technical Program Lead - Business Insights & Technology (BI&T) – Global Product Development and Supply (GPS)
Position Summary: Bristol Myers Squibb (BMS) is driven by its vision to transform patients’ lives through science. The Product Development Excellence (DevEx) Technical Program Lead for the Global Product Development and Supply (GPS) division plays a crucial role in advancing this vision. GPS is responsible for developing, manufacturing, and supplying quality clinical and commercial medicines to patients worldwide.
Based in New Jersey, USA, this leadership role partners with DevEx GPS Product Development (PD) leadership and oversees the technology delivery of DevEx related workstreams. DevEx program is intended to accelerate development timelines and transform the way GPS brings new medicines to market. The DevEx Technical Program Lead will be responsible for leading a team of GPS BI&T engineers building information model, semantic layer and knowledge graphs for PD scientific domains, working in close partnership with other BI&T leaders and GPS stakeholders. This role will partner with the PD BI&T lead to ensure applications and technology teams are mobilized to deliver DevEx outcomes. This role requires a visionary leader who can play a leading role in shaping the strategy for how best to deliver the Model First Strategy, advance the data as strategic asset vision for PD and deliver impactful technology solutions in an operationally effective manner, and foster collaboration across global teams. This role will directly report to the GPS BI&T Analytics Enablement Leader, to manage close alignment with modern analytics capabilities, and functionally reports to the Product Acceleration & Capabilities BI&T Lead to align with overall BI&T accountability to the PD DevEx program.
If you are passionate about harnessing the power of technology and analytics to make a difference in patients’ lives, this role offers an exciting and rewarding opportunity.
Roles and Responsibilities:
Leadership & Team Development:
Develop a high-performing DevEx Program team, ensuring alignment with GPS DevEx Program vision, strategy, and roadmap.
Directly manage and mentor team of technology professionals delivering data capabilities to support DevEx strategy, fostering an inclusive, collaborative, and high-engagement culture.
Indirectly manage and influence other technology professionals from the broader GPS BI&T and Enterprise BI&T team, in close partnership with PD BI&T lead.
Implement robust onboarding, cross-training, and knowledge-sharing programs to build a resilient team capable of delivering consistent results.
Participates in all DevEx Agile ceremonies, lead the planning and mobilization phase for new workstreams, oversee and manage interdependencies between various workstreams and ensure resource management is in place to actively manage and resolve bottlenecks.
Develop a DevEx Program operating model that manages work intake and prioritization, drives innovation, and cross GPS BI&T collaboration in an optimized manner.
Lead planning, diversity efforts, and colleague development initiatives to sustain a robust talent pipeline.
Technology Strategy & Innovation:
Directly responsible for developing, managing, and delivering the SPARTAN platform technology (Spartan is BMS branding for technology platform used to build knowledge graphs leveraging Neo4J) roadmap for DevEx Program in a manner that delivers compelling value and ensures the overall success of the program.
Actively partner with GPS DevEx Program leadership & PD BI&T lead to ensure technology “art of the possible” is central to the program’s strategy and roadmap.
Partner with PD BI&T teams and GPS stakeholders experimenting with emerging technologies, scaling viable solutions to deliver measurable business value to DevEx Program.
Ensure adherence to technical best practices in SDLC and analytics output, including scalable solutions, code version control, documentation standards, and deployment.
Evaluate new technologies and proactively recommend impactful innovations with high ROI for inclusion on the program roadmap.
Stakeholder Collaboration & Engagement:
Build strong relationships with GPS PD DevEx business stakeholders, BI&T teams, and cross-functional colleagues across global locations.
Enterprise mindset:
Actively seek out ways to partner with other BI&T Teams and leverage existing technologies and solutions in the most effective way for DevEx Program.
Partner closely with other BI&T leads to leverage learnings from DevEx, such as knowledge graph, in other GPS domains.
Ruthless prioritization: work closely with GPS PD leadership to define DevEx Program priorities and deliver the most impactful solutions aligned with business objectives.
Requirements:
Professional Experience:
7+ years of relevant experience in Information Technology, data analytics, or pharmaceutical/healthcare industries.
5+ years in a leadership role managing large program teams and delivering IT or analytics solutions.
Hands-on experience with SDLC methodologies, including DevOps, Agile, and Waterfall, in regulated environments.
Proven track record of managing complex projects, including resource allocation and budget oversight.
Experience with biopharma PD is strongly preferred.
Experience with biopharma manufacturing operations, supply chain, or quality controls is a significant plus.
Technical Expertise:
Proficiency with a modern suite of analytics tools and technologies, including Neo 4J, GitHub, SQL, Python, R, dbt, Domino, Tableau, etc.
Experience with building and operationalizing technology applications.
Experience with scientific applications used in labs (ELN, LIMS, LES etc).
Experience with cloud computing environments and services, such as AWS.
Experience with graph database technology preferred.
Hands-on experience with agile methodologies and tools like JIRA.
Leadership Skills:
Proven ability to lead technology teams, foster collaboration, and drive innovation.
Excellent project management skills, with a focus on delivering high-quality solutions on time and within budget.
Strong communication skills to translate analytics output into actionable insights for diverse audiences.
A customer-oriented mindset with an eagerness to solve business problems and drive continuous improvement.
Ability to work effectively in a matrixed organization and across global locations.
Educational Background:
Bachelor’s degree in technology/engineering related fields, scientific research, or analytics discipline is required.
Advanced degrees (M.Tech or Ph.D.) in relevant fields are preferred.
Other Requirements:
Ability to work hours that provide sufficient overlap with Hyderabad teams.
Occasional travel to global BMS locations.
#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.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Drug Dev and Preclinical Studies
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.
Translational Medicine at BMS
Translational medicine is a department within the Research organization that facilitates the transition of drug candidates from early to late-stage clinical development, their approval and life cycle management. Early-stage translational development activities enable rational determination of dose-schedule and responsive patient populations, based on deep understanding of drug mechanism of action and disease segments. Late-stage translational development activities build upon the early work, additionally exploring mechanisms of response/non-response, rational drug combinations and product differentiation. The late-stage translational development function is responsible for the development of translational strategies to support the development, and maximize the potential, of BMS’s therapies post-clinical proof-of-concept, including registrations and life-cycle management. Translational disease strategies in Alzheimer’s /Neurological Diseases are derived from long term investments in developing data and deep expertise in disease biology, neuroinflammation and patient segments to assist science driven strategies for the development of the neuroscience pipeline.
Position Description:
- Develops and executes translational disease strategy in Alzheimer’s /Neurological disease areas with deep disease expertise
- Leads and oversees execution of disease strategy including but not limited to various aspects of patient selection strategies
- Serves as scientific expert in generating novel hypotheses for targetable biologies based on novel discoveries integrating disease work with literature and deep expertise in neuroscience
- Manages cross functional disease project teams with key interfaces in IT, bioinformatics, data sci, stats, external collaborators, contractors, other disease strategy leads and asset leads
- Maintains relationship with translational clinicians for identifying new opportunities and for gaining disease insight
- Identifies needs, gaps and translational disease questions and applies knowledge across all assets in BMS portfolio in neuroscience area
- Leads small and large collaborations with academia and industry partners to identify biobanks, clinical trials and existing databases to collate multi-parameter genomic, immune and clinical datasets to mine for novel biomarkers of unmet need patients in conjunction with computational biologists, data scientists and statisticians
- Collaborate and guide bioinformatics partners on biological questions to deliver biomarkers and biological understanding from whole transcriptome, whole exome, and/or whole genome data, epigenetics, proteomics, immune profile and single cell data in order to support drug discovery and development in Alzheimer’s /Neurological Diseases.
- Manage relationships with key internal stakeholders including regulatory, clinical and commercial and scientific communications and external collaborators to develop translational analysis plans and timelines, communicate analysis results.
- Represent the Neurology Translational Medicine function at various internal meetings and provide domain knowledge and disease expertise to cross-functional teams.
- Direct and support publications in high quality scientific, technical or medical journals.
Qualifications:
- PhD degree in a neuroscience-related field
- Minimum of 8 years post-PhD experience, with demonstrated scientific leadership in integrating, analyzing, and interpreting multimodal biological data in an academic and/or industry setting.
- Strong background in neuroscience with focus on Alzheimer’s disease, human genetics/genomics, molecular and cellular biology is required. Knowledge in immunology is a plus.
- Ability to work in a fast-paced environment with rapidly changing and competing priorities and ambiguity.
- Strong team player with the ability to work in cross-functional teams. Excellent communication and collaboration skills.
- Prior experience with clinical trials preferred but not essential
- Strong track record of high-quality scientific publications in relevant fields
#LI-ONSITE
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Clinical Development
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 Associate Director, Risk Management and Central Monitoring (AD), is a member of the Risk Management and Central Monitoring team under Clinical Oversight and Risk Management (CORM).
The Risk Management and Central Monitoring capability is a critical element of the Risk Based Management (RBM) framework and will drive and support the strategic direction of Risk Based Management within the business.
Each AD will be assigned a significant part of the Bristol-Myers Squibb clinical trial portfolio and will work conjunctly with their peers to ensure consistency across the function in conducting risk oversight to identify potential risks and control strategies. This role is responsible for the remote assessment of risk and data quality analytics that monitor issues and identify emerging risks in Asset/Portfolio/TU variables (trends / outliers / unusual patterns) through the review of aggregate clinical and operational data leveraging powerful statistical methodologies.
The AD will be responsible for Asset/Portfolio/TA risk analysis and reporting and will be key contributor to the Clinical Development Team to support the oversight of compliance, patient safety, data quality and reliability.
The AD role has accountability to evaluate, monitor, escalate and report risks to the Sr Director Risk Management and Central Monitoring and/or Global Program Team that could potentially have a broad significant and/or systemic impact on quality, compliance, and operational deliverables for discussion with the relevant Governance Committee.
The AD forms a key partnership with the CORM colleagues, R&D Quality (Risk Governance and Operations), applicable GDO & TA functions and their leaders.
Duties/Responsibilities
AD is accountable for ensuring a high quality and consistent Protocol De-risking process is applied to studies within their portion of the portfolio, resulting in a robust Integrated Risk Management Plan (IRMP) which is maintained and kept relevant throughout the lifecycle of the study
AD ensures a high quality and consistent holistic data review strategy is applied to studies within their portion of the portfolio, resulting in a robust Integrated Data Review Plan (IDRP)
Responsible for regular risk monitoring for their allocated portion of the portfolio and providing a holistic risk report at the agreed frequency.
Ensure appropriate escalations of emerging risks (including QTL deviations) to the relevant governance committee (e.g. Quality Council/Therapeutic Area leadership) and proactively shares knowledge and insights across the CORM group.
Connects the outcomes of Risk Review Meetings of studies within their portion of the portfolio to their additional risk analyses in order to feed into higher level risk logs via a compelling ‘risk story’ at asset/portfolio/TA level
Lead or contribute to the development and maintenance of metrics that inform the evaluation of risk monitoring performance and effectiveness.
Leadership or participation in large strategic initiatives / continuous improvement opportunities within the CORM and broader organizations
Drive and support the strategic direction of Risk Based Management within the business to include leadership of RBM innovation (including representing the Company in interactions with key external partners as part of any committee or industry group relating to RBM), education and embedding
Ensure effective quality oversight and management of external partners (e.g. Function Service Providers, CROs, technology providers, etc.) performing Risk Management or Central Monitoring activities on behalf of BMS
Develop strong and productive working relationships with key stakeholders throughout TDS, GDO, and BMS with the ability to think strategically across a broad portfolio and effectively express his/her views to senior management
Coach, mentor and develop new team members.
Develop and promote a workplace culture that values diversity of thought, promotes integrity and creates an atmosphere that supports coaching and fosters accountability
Takes on additional responsibilities as directed by leadership
Reporting Relationship
This role will report to a member of the Risk Management and Central Monitoring Leadership Team within the CORM organization.
Qualifications
A minimum of a bachelor’s degree in one of the following disciplines or related field: Life Sciences (preferred); Analytics; Data Science; Statistics; Business; is required.
At least 8 years in the pharmaceutical industry with sound understanding of drug development and 5 years of experience in clinical trial operations and/or Good Clinical Practice is expected.
Significant expertise in Risk-Based Monitoring principles (Quality by Design, Risk Assessment & Control) and relevant tools (e.g RACT, risk analytics platforms, Veeva and other quality systems)
Technical expert in data analysis and interpretation using data visualizations to derive meaningful insights; and an ability to effectively tell the story of the data findings
Ability to lead the development and implementation of data visualizations and analyses to support Risk Management / Central Monitoring business needs.
Expertise in GCP, compliance and regulatory expectations with significant experience of audits and health authority inspections, root cause analysis and CAPA.
Outstanding Leadership skills with an ability to influence and manage key internal stakeholders (including senior leadership) as well as external stakeholders (including Health Authorities).
Excellent communication, collaboration and teamwork skills with an ability to drive cross-functional stakeholders (including senior leaders) to consensus and resolve conflict in a constructive manner.
Ability to understand organizational and industry direction, anticipate future trends, opportunities, and challenges and adjust strategies accordingly.
Open mindset with an ability to be flexible, responsive, and proactive in addressing new challenges, opportunities, and demands.
Ability to articulate a clear, compelling vision for change that inspires and motivates others.
The starting compensation for this job is a range from $168,000 -$210,000, plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
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