The GPS (Global Product Development and Supply) Analytics team is a newly formed and growing team within Business Insights and Analytics focused on partnering with the BMS GPS organization to answer key business questions that will drive significant value and prioritized business decisions using advanced analytics and data. These questions span the full spectrum of GPS responsibility from Product Development through Manufacturing Operations, Quality and Global Supply Chain.
Purpose/Objective of the job
The Director of Operations Analytics will lead efforts to use analytics and develop analytical tools to optimize BMS’ integrated quality organization team by:
Supporting Priority Business Decisions – The Director will work very closely with Quality, other GPS leadership and R&D leadership to understand the BMS Quality strategy, priorities, and role in the broader BMS organization. The Director will leverage organizational knowledge and work closely with Quality, R&D and other stakeholders at all levels to address priority business questions across BMS, with a focus on value delivery. This includes all steps from problem identification to analytics solution development to value delivery tracking.
Strengthening Partnerships – The Director will play an important role in developing and strengthening the relationship between BIA and Quality stakeholders at all levels (including their respective Leadership teams). The Director will also work closely with other GPS teams including Product Development and with R&D. Additionally, the Director will work closely with other BIA teams and BMS Enabling Functions (IT, Finance, Procurement, etc.) to ensure optimal engagement with all stakeholders.
Building and Driving Analytics and Capabilities – The Director will play a critical role in development and implementation of analytical solutions to answer these business questions. The Director will lead efforts to develop analytical prototypes leveraging an agile approach and partner with Operations, IT and Operational Excellence organizations to drive uptake and engrain the analytical solutions into core business processes. Additionally, the Director will ensure that analytical solutions/outputs are simple enough for the business to use and lead refinements of the solutions to maximize value delivery.
Key Responsibilities and Major Duties
Establishes a close working partnership and relationship with business and IT stakeholders, especially within the Quality, Procurement and Business Continuity organizations
Effectively partners and collaborates with other BIA team members (including but not limited to Supply Chain Analytics, Manufacturing Operations Analytics, Product Development Analytics, GPS Business Performance Management, GPS Data Science, Demand Planning, Commercial Analytics, etc.) to identify and evaluate current and future analytics needs for GPS and to deliver a consistent BIA engagement model with stakeholders
Effectively partners and collaborates with a broad set of cross functional counterparts (including IT, Procurement and Finance) to achieve organizational objectives
Understands, demonstrates, and drives adherence to all BMS operating policies
Supporting Business Decisions
Identifies and contextualizes critical business questions/issues, working to embed an objective and unbiased point of view into the business conversation
Drives the application of fact based decision making for key questions within the GPS portfolio enabling priority business choices
Develops and maintains a deep understanding of GPS business priorities, meeting agreed upon analytics deliverables/timing
Supports and champions a culture of analytics and fact-based decision making through the utilization of standard methodologies and approaches
Building and Driving Analytics and Capabilities
Identifies new opportunities to further leverage analytics, data and analytical solutions – prioritizing opportunities with the biggest potential benefit to the business
Designs, develops and implements a broad array of business analytics that solve complex problems in a computationally efficient and statistically effective manner – working closely with internal teams and external partners to optimize solution and value delivery
Works with Quality and other business stakeholders to ensure that analytics solutions are well understood by the business for optimal use and value delivery. Makes complex analytical solutions simple enough for the business to use, and drives uptake to engrain analytics solutions into standard business processes by working with business owners and the Operational Excellence team.
Ensures best practice adoption within stated areas of responsibility, applying appropriate levels of technical capability, standardization and subject matter expertise
Continuously develops a diverse team that has required business knowledge and appropriate analytical skillsets to support team (this role will require recruiting of team members)
Proactively manages planned and ad hoc analytics requests, ensuring appropriate prioritization, consistent quality and timeliness in delivery to business stakeholders
Leverages standards for the provision of analytics to support planning and decision making processes, and utilizes appropriate escalation processes
Provides input/feedback and works actively to improve and enhance capabilities related to the GPS BIA team and Quality organization
PhD in analytical / quantitative field & 4+ years of experience implementing advanced analytics to address significant business problems OR…Masters in analytical / quantitative field (i.e. statistics, engineering, computer science)
7+ years of experience implementing advanced analytics to address significant business problems.
Experience leading teams and adapting in an analytical context
Experience and conversant in applied analytics for solving business problems including experience developing frameworks around analytical capabilities for teams
Knowledge of application of analytics in the following areas:
Quality (Commercial and Clinical)
Risk Analysis / Mitigation
Experience with the application of predictive modeling and / or optimization to business problems.
Proven experience operating successfully in a complex organizational environment
Experience interacting and building effective relationships with senior management, understanding, anticipating, and fulfilling their insight/analytical information requirements.
Can communicate effectively to audiences of varying degrees of familiarity with analytics
Can conceptualize business problems and develop frameworks around analytical methods for teams
Strong project management and people development skills
Familiarity and knowledge of some of the following analytical tools (including, but not limited to):
Provides computer technology support to the Computerized Equipment at Production, Facilities and Utilities Areas. Performs process analysis and recommends improvements to existing processes through the use of state-of-the-art computer technology. Coordinates and executes the installation, troubleshooting, maintenance, qualification and upgrade for new and existing computerized systems. Performs project management functions for the execution, implementation and start-up of new computerized systems. This position must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.
Ensures the continue operations of all Process Equipment including programming and ongoing maintenance for Production, Facilities and Utilities Areas.
Supports all Process Equipment and Process Automation Systems for Production, Facilities and Utilities Areas.
Support the Process Equipment team during process integration for major computer system applications that impact the Production, Facilities and Utilities Areas.
Assure computer operations are maintained considering Plant policies, procedures and FDA regulations under cGMP’s and other regulations applicable.
Perform process equipment analysis and recommends improvements to existing processes through the use of state-of-the-art computer technology and participates proactively as a team member of implementation projects for new integrated business application and processes automation, providing consulting advice in the use and management of technology.
Installs, configures, troubleshoots, and maintains computerized systems in Production, Facilities and Utilities Areas. These systems include (not limited to):, PLCs, SCADA, and Fourth generation languages for interfaces and report development.
Provides user training and continuous support to assure proper use of the software applications following established operational procedures and user support during problem solving situations associated with systems implementation.
Reviews computer related software applications or computer programs to ensure that Plant standards are met and that programs are capable of being integrated with other software applications as required.
Evaluates workload and capacity of computer systems to determine feasibility for expanding, upgrading or enhancing operations.
Reviews and test programs to ensure that they meet manufacturers recommend requirements for hardware and software at the personal computer and/or host computer system level. Perform changes to applications or to their corresponding configurations to assure software works as expected before installing it in the user environment.
Evaluates and closes change control documentation assuring the validated and compliance state of the environments
Tests computer system to determine criticality of component loss prioritizes importance of components and writes recommendations for recovering losses and using backup/restore applicable procedures. Adheres to data integrity and system security applicable practices under these situations.
Reads technical journals or manuals and attends vendor seminars or user forums to learn about new computer hardware and software.
Provides project status through the use of project plans and perform best efforts to achieve projects milestones within the pre-established due dates. Provides alternatives and problem solving initiatives during possible project delays or possible showstoppers.
Prepares or provides support in the preparation of procedures (e.g., Systems Life Cycle) and defines standards for software automation, system integration and defines the strategy for plant automation and process integration through an analysis and design/re-design of current systems and processes.
Prepares and/or reviews system related procedures such as: Operational, Security, Backup and Restore and Disaster Recovery.
Contacts hardware or software vendors (if applicable) to report problems. Coordinate and implement vendor recommendations when approved or accepted by the area Supervisors or Manager.
Assures reported problems are solved by implementing corrective actions like (but not limited) user retraining, changes to existing SOPs, applying software fixes or hardware fixes, Information Resources colleagues recommendations, etc. These activities must comply with current applicable change control procedures.
Provides sound problem solving techniques to resolve issues and qualification problems.
Assist in the management of Capital Appropriation Requests (CAR’s), and timeline of process automation projects and implementation and support Process Automation initiatives
Keeps abreast with current technology
BS in electrical, computer, mechanical engineering and or related fields.
Five-(5) years of experience in pharmaceutical operations or Manufacturing processes with proven project management skills which four (4) of the five years experience, must be in Process automation in pharmaceutical environment with two (2) years experience in Computerized systems validation.
Proficient knowledge of computer system life cycle concepts, change control systems and FDA regulatory requirements, including 21 CFR Part 11.
Proven experience issuing and preparing Computerized Functional Requirements and Design Specifications.
In-depth knowledge of the science and physics involved in the design, installation, commissioning and validation/qualification of computerized systems and PLCs as applied to pharmaceutical production environment.
Broad knowledge of relevant governmental regulations, cGMPs and guidelines pertaining to a biopharmaceutical manufacturing plant.
Experience with external and internal regulatory audits (FDA, EMEA, Otsuka, Sanofi, etc.)
Knowledge of pharmaceutical business processes and equipment.
Knowledge of mechanical concepts, electrical controls theory and electronic circuitry.
Proven skills in projects management, systems development and implementation of manufacturing, MES Systems, and quality related systems. Knowledge of SAP/R3 highly desirable.
Ability to manage and operate computer software packages used for data acquisition systems and PLC programming.
Strong Databases and networking knowledge’s.
Able to read, interpret, and understands electrical/mechanical drawings.
Ability to review SOPs and work instructions
Flexible and responsible
Significant abilities and aptitude to analyze data detecting inconsistencies, determining relative importance and to solve complex technical situations based on data
Bilingual English/Spanish, both written and verbal are required
Able to interact effectively with people to establish and maintain excellent working relationship with internal and external customers at all organizational levels and disciplines in such a way to facilitate the validation/qualification work.
Able to plan and prioritize multiple complex activities simultaneously (i.e., installation, integration, commissioning and validations/qualifications, timelines, etc.) by using sound Project Management Skills.
Willing to work irregular hours, rotative shifts, weekends and holidays, when necessary.
The Regulatory Affairs area is strategic for the growth of the company. Through regulatory processes with ANVISA, the company expands and renews its portfolio. The regulatory environment is constantly changing, requiring companies to be ready to anticipate them, analyze their impacts, plan and implement them in a timely and effective manner. In addition, the Regulatory Affairs area is also responsible for ensuring that the company complies with the applicable health regulations in order to continue business, avoid penalties and protect the company's image. The Regulatory Affairs Junior Analyst should be prepared to work in this environment and deliver the expected results through teamwork, timely and quality under close supervision.
Skills, Competencies and Knowledge
Knowledge of the main regulations applicable to area
Teamwork, interpersonal relationships, commitment and dynamism
Ability to communicate fluently (written and verbally) in English and Portuguese
Ability to organize / prioritize tasks
Commitment to timely deliver quality results
Knowledge on Office package
Bachelor’s degree (Pharmacy preferred) is required.
Bristol Myers Squibb (BMS) has one of the richest biopharmaceutical pipelines in the industry. We discover, develop, and manufacture lifesaving and life altering drugs in cancer, hepatitis C, heart disease, and other therapeutic areas. BMS also has one of the most reliable supply networks and our clinical operations program is among the best and busiest anywhere. We are a company that is forward thinking, a company in which diversity and inclusion are at the forefront of how we view our talent and how we work. Our science is second to none and the transformation work underway will enable us to continue to lead our peer group.
Bristol-Myers Squibb External Manufacturing is looking for a Senior Logistics Planner on a Fixed Term Contract to support our Supply Chain and Logistics team.
Manages the planning of all Transportation Movements with all BMS approved transportation companies and storage facilities, on behalf of ExM from all sites (CMOs, DCs, Intercompany etc) for EMEA/APAC.
Manages, resolves issues, implements improvements and ultimately fosters relations between CMO’s and BMS approved transportation companies.
Manages all transportation redeployments to markets and returns to manufacturing sites.
Accountable for the Investigation, and successful resolution, of all Transportation & Distribution incidents on behalf of ExM in Trackwise.
Owns the LIR system on behalf of ExM Supply Chain as subject matter expert (SME), and is the key point of contact for the LIR global team.
Acts as the Supply chain representative at the Quality AFI (Accountability for Investigation) bi weekly meeting.
Attends all Quarterly Business Reviews (QBR) with BMS approved Transportation Companies to drive Performance, Mitigate Risks and ensure alignment with ExM goals and objectives.
Provides input to manager for preparations for QBRs
Responsible for all transportation decision making on behalf of ExM in the EMEA/APAC region during any period of absence of the Site Leader Shannon.
Demonstrates that Logistics are managed in the most efficient and cost effective manner by utilising OPEX tools to drive Continuous Improvement to meet, and exceed customer expectations.
Responsible for reviewing, analysing and authorising all ExM Freight spend.
Key Requirements and Qualifications:
Understands BMS Supply Chain, products and markets.
Good understanding of business specific organisations & functions (Quality, Finance, SRM, Procurement, EHS, Replenishment & Customer Planning).
Must be GMP & GDP trained and have a clear understanding of the Quality requirements of the business.
Detailed knowledge of ExM Quality Systems and procedures.
Creates and maintains strong working relationships within the BMS organisation and externally with customers, BMS approved transportation companies & CMOs.
Self-driven with a strong customer focus and possess skillset to work on own initiative within a team environment to drive issues to resolution.
Strong knowledge of ERP, ideally SAP and related Data Analysis Tools to include the Microsoft Office suite.
Demonstrated capability in the use of OPEX tools for root cause analysis. Ability to close-out investigations and issues with CMOs and BMS approved Transportation companies
Ability to translate technical issues into business impact and relevant solutions.
Knowledge of the EU Directives on the wholesale distribution of medicinal products for human use.
Knowledge of the guidelines on GDP of medicinal products for human use.
Knowledge of Customs clearance import and export procedures for shipments moving between EU & Non-EU locations.
Knowledge of the Classification, Preparation and Transportation of Dangerous Goods to ensure compliance with IATA, ADR & IMDG regulations.
Strong knowledge of Packaging & Transportation solutions to mitigate against logistics incidents that could jeopardise the integrity of pharmaceutical product.
Appreciation of performance metrics and their value in influencing Supply Chain results.
Must have knowledge of and model the BMS core behaviours
Primary Degree in Supply Chain Management or Logistics Management.
The Manager – Quality Engineering position maintains responsibility for the Syracuse Annual Product Quality Review (APQR), Manufacturing Summary Report and Statistical Alert, Quality Risk Management (QRM) programs.
Duties/Responsibilities:(describe the most critical responsibilities/accountabilities of this position)
Site lead for APQR including primary authorship, network data support and coordination, and E2E APQR process support
Site champion for QRM, responsible for program leadership, training, authorship (as appropriate) and QA oversight of the QRM program (Impact assessments)
Review and approval of Manufacturing Summary Reports which impact Syracuse commercial products
Review and approval of Statistical Alert Excursions (SAEs) as necessary
Provide Quality Engineering support for site projects and initiatives
Perform Quality Review and Approval for Site Master Drawings
Provide QA oversight for site activities
Backup Quality Lead Coordinator, as necessary.
Support network related projects that relate to the QRM activities
Actively participate and support inspection readiness activities and corporate audits
Approve site SOPs and other documents requiring QA review and approval.
Drive continuous improvement initiatives through participation in process and system improvements at the site and network levels
Demonstrate appropriate examples for quality compliance behaviors and attitudes, thereby shaping the culture.
Display the flexibility, confidence, and decisiveness to effectively establish proper priorities and manage through the dynamic of frequent change.
Demonstrate sound judgement while balancing risk in assuring compliance with regulations, practices and policies
Specific Knowledge, Skills, Abilities, etc: (describe the most critical competencies which are required to perform the job)
This position requires the following knowledge and skills:
Broad knowledge of QRM principles is required
Engineering knowledge is highly desired
Demonstrate knowledge of subject matter related to quality and compliance is required
Familiar with and able to interpret relevant regulations and regulatory agency inspection expectations
Excellent communication, technical writing and computer skills
Demonstrate flexibility and capability of managing multiple tasks
Demonstrate excellent organizational skills and ability to effectively prioritize work
Detail oriented with a sense of urgency for completing tasks
Ability to perform tasks completely and independently and complete assignments without detailed direction
Communicate complex information clearly and concisely
Education/Experience/ Licenses/Certifications: (list required education and experience, along with any additional education/experience/qualifications that are preferred)
Bachelor’s degree, M.S. or PhD and 5+ years relevant experience in Quality Assurance or within a related technical function with increasing cross-functional responsibility.
Physical Demands:(see items to consider on last page)
Primarily an office based position requiring sitting for prolonged periods, walking, repetitive use of arms, hands, wrists.
Work Environment:(see items to consider on last page)
Primarily office space. Occasional exposure to both manufacturing and laboratory facilities where one must don appropriate gowning and personal protective equipment and be aware of the presence of workplace hazards including pressurized liquids, gases, high temperature water and steam, ultralow temperature cryogenic liquids and chambers, and hazardous chemical reagents
Travel: (only include if travel is required)
Supervisory Responsibilities:(only include if supervisory responsibilities are required)
None. This role is an individual contributor role.
Provide administrative support for Exec. Director and Group Director, based in our Lawrenceville, New Jersey research facility, both of whom have cross site line management and matrix leadership responsibilities. Focus is support of supervisor, MDT leadership team members, and staff with primary emphasis on the team members in Lawrenceville, NJ. Support of the entire organization will be done in coordination with administrative staff in our Cambridge, MA site.
Calendar management and meeting scheduling for supervisor and Group Director
Assist with group operations through scheduling team meetings, Town Halls, performance check-in meetings, etc.
Maintain up to date organizational information for department (organizational charts, etc.)
Travel arrangements for supervisor, Group Director, and occasionally for extended leadership team
Travel and entertainment expense tracking and report generation and distribution
Assistance with managing the departmental operating budget, including assembly of budget reports from SAP
Manages computational software purchases from quote through follow up on invoicing.
Manage purchases as necessary, including office supplies, lab supplies and equipment
SharePoint administrator/site owner for departmental site
Coordinate recruiting visits, including travel arrangements
Assist with employee onboarding and exits
Strong communication and interpersonal skills
Ability to plan proactively, anticipate needs and take action within an agreed upon framework
Ability to work on multiple tasks simultaneously and to balance priorities through the utilization of strong organizational skills and networks across the organization
Proficiency in MS Office suite of programs
Proficiency in other key support programs such as SAP SRM, Ariba, Concur, etime or demonstrated ability to learn and utilize new software
5+ years in an administrative assistant role desired; previous experience in a biotech or pharma R&D setting is a plus
Historiquement spécialistes de la lutte contre la douleur et de l’automédication, les laboratoires UPSA (Union de Pharmacologie Scientifique Appliquée) ont été créés à Agen en 1935 par le Docteur Camille Bru.
Intégrée dans le groupe Bristol-Myers Squibb depuis 1994, UPSA est aujourd’hui à la fois une société et une marque. Depuis huit décennies, UPSA a développé une forte expertise en Europe dans la douleur, l’état grippal, la vitalité, la digestion et la qualité du sommeil. UPSA, la recherche, l’excellence qualité et la production en France : à travers sa gamme d’automédication, UPSA développe et met à disposition des médicaments pour soigner les maux du quotidien.
Depuis 1951, l’usine de production de la société UPSA est implantée à Agen dans le département du Lot-et-Garonne (47) et les sites de distribution sont situés à Agen et à Fontenay-sous-Bois, en banlieue parisienne (94). Parce que la santé bouge, la société UPSA est en perpétuelle quête d’innovation et son pôle de développement galénique à Agen lui permet de s’adapter aux évolutions des besoins des patients.
Description de la mission :
Au sein de l’équipe de conditionnement d’une de nos sites de Production, vous êtes en charge de :
Réaliser des opérations de conditionnement en assurant la traçabilité sur les documents référencés.
Réaliser les contrôles de qualité en cours de production et mettre en œuvre, si besoin, des actions correctives.
Assurer les étapes de nettoyage et vide de la ligne suivant les procédures en vigueur.
Réaliser les changements de format et de lot.
Enregistrer les qualités et heures sur les outils informatiques (Spiral, Labvantage, SAP…).
Suivre les indicateurs de production.
Participer aux démarches de progrès du service conditionnement.
Mettre en application les procédures relatives à l’environnement, à la sécurité et à la qualité dans le cadre de ces activités.
Formation Bac, Bac Professionnel, niveau BTS ou expérience équivalente de 3 à 5 ans.
Expérience dans la conduite de ligne de conditionnement idéalement dans le secteur pharmaceutique.
Connaissance des Bonnes Pratiques de Fabrication souhaitée.
Connaissance des outils informatiques (SAP, Excel...)
Un sens aigu du relationnel, de la méthodologie d’analyse et de la gestion des priorités sont nécessaires.
Autonomie, dynamisme, rigueur, réactivité et goût du travail en équipe, sont également des atouts indispensables pour ce poste.
This Senior Research Investigator/Principal Scientist will join the Cancer Resistance Biology Research Team at Bristol-Myers Squibb in Cambridge, MA to support preclinical drug discovery and development against therapeutic targets at the intersection of intrinsic tumor genetics and the extrinsic tumor microenvironment.
The qualified candidate is a highly motivated, interactive, and creative individual who possesses substantial experience in studying tumor biology and genetics, and experience or strong interest as to how these features impact immune responses to the tumor. Since BMS is a matrixed organization, the candidate will be expected to effectively collaborate with colleagues in supportive line functions (including oncology, immuno-oncology and immunology, medicinal chemistry, candidate optimization and translational medicine) to advance preclinical development of therapeutic candidates to early clinical development. The successful candidate will demonstrate clear and professional verbal and written communication, capable of presenting scientific results to multidisciplinary teams, senior management and at external scientific meetings. The candidate will develop external partnerships/collaborations to advance internal programs, as appropriate. S/he will also manage a small in vitro biology lab to support their project responsibilities as well as to contribute to team held objectives, including new project and target ideas. This position is located in Cambridge, MA. There will be less than 10-20% travel.
A Ph.D. degree with a minimum of 4+ of relevant experience in cancer biology and genetics, immnuo-oncology or a closely related field
Industry experience with demonstrated abilities to drive preclinical development from target ID to clinical candidate selection, especially experience in small molecule drug discovery.
Demonstrated expertise to independently apply bioinformatics and data mining through multi-variate analysis; ability to effectively interact with core bioinformatics colleagues, as well as to use desktop tools/interfaces (e.g., Oncoland, Wuxi) and public databases (CBIO, Achilles, etc.)
Excellent oral and written communication skills, as is the ability to effectively present scientific data and concepts to international standards.
Experience or the ability to innovate in novel preclinical in vitro, in vivo and ex vivo oncology model development that enables bridging from tumor biology to host immunity is highly desired.
This Director level position will join the Cancer Resistance Biology Research Team at Bristol-Myers Squibb in Cambridge, MA to lead preclinical drug development against therapeutic targets at the intersection of intrinsic tumor genetics and the extrinsic tumor microenvironment.
The qualified candidate is a highly motivated, interactive, and creative individual who possesses substantial experience in studying tumor biology and genetics, and experience or strong interest as to how these features impact immune responses to the tumor. The candidate will be an experienced program team leader and drug hunter. S/he will be an effective manager and mentor to more junior PhDs and associates. Since BMS is a matrixed organization, the candidate will be expected to effectively collaborate with colleagues in supportive line functions (including oncology, immuno-oncology and immunology, medicinal chemistry, candidate optimization and translational medicine) to advance preclinical development of therapeutic candidates to early clinical development. The successful candidate will demonstrate clear and professional verbal and written communication, capable of presenting scientific results to multidisciplinary teams, senior management and at external scientific meetings. The candidate will develop external partnerships/collaborations to advance internal programs, as appropriate. Similar they will be involved in the evaluation of partnering and other business development opportunities. S/he will be responsible for building and supervising a group of up to 4 PhD Investigators and 6-8 research Scientists/Associates. There will be less than 10-20% travel.
A Ph.D. degree with 8- 10 years of relevant industrial experience in cancer biology and genetics, immnuo-oncology or a closely related field
Industry experience with demonstrated abilities to drive preclinical development from target ID to clinical candidate selection, especially experience in small molecule drug discovery
A proven track record in the field of cancer biology and genetics, as evidenced by publication record
Demonstrated expertise to independently apply bioinformatics and data mining through multi-variate analysis; ability to effectively interact with core bioinformatics colleagues, as well as to use desktop tools/interfaces and public databases
Management/supervisory experience is essential.
Excellent oral and written communication skills, as well as the ability to effectively present scientific data and concepts to international standards.
Experience or the ability to innovate in novel preclinical in vitro, in vivo and ex vivo oncology model development that enables bridging from tumor biology to host immunity
Experience in studying the tumor stromal compartment
Ability to effectively interact with core bioinformatics colleagues, as well as with translational research scientists to generate testable hypotheses for targetable nodes that drive cancer resistance to current immuno-therapies.
3-4 PhD Investigators, 6-8 Research Scientists/Associates
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. 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 the resources to pursue their goals, both at work and in their personal lives.
Senior scientific operations leader responsible for planning and driving execution of strategic planning and delivery of all Translational Medicine (TM) activities from Translational Research through Clinical Execution and Diagnostic Development and Commercialization; partnering with other project management teams to create a seamless infrastructure to support the ability to efficiently manage both an individually held book of work, as well as supporting a team of leaders across the balance of the fully development portfolio.
Integral partnering with one or more TM team(s) to develop project plans and drive execution to inform clinical progress, major activities include: protocol design, rapid data acquisition, specimen collection, selection, routing, testing, and ingestion/analysis/reporting of analytical results.
Driving complete integration with early translational research activities through diagnostic development and commercialization activity – ensuring alignment of strategy and plans across multiple disciplines within the Translational Medicine organization and related activities in Discovery, Commercial, Medical and Regulatory organizations
Managing issues and risk mitigations for the portfolio of assets managed by the TM Team Leader, primary scope includes:
Biomarker strategies and tactical clinical plans, translational R&D efforts and bioinformatics approaches to scientific evaluation of critical hypotheses,
External collaborations for data acquisition, analysis and study activities,
Publications and presentations (internal and external), and
Regulatory responses and interactions.
Establishing meeting agendas to drive TM portfolio delivery and documenting outcomes, decisions and key learnings to enhance collaboration and communication.
Overseeing the consistency, integrity, completeness, and internal dissemination of biomarker data generation following review of results.
Supporting efforts to curate and integrate datasets (biomarker results, sample characteristics, clinical outcome) to facilitate analysis, e.g. via Spotfire or other data visualization capabilities.
Driving biomarker analysis and activities, including but not limited to, facilitating data transfer specification creation in collaboration technical leads and coordination with both internal and external partners to support biomarker sample movement.
Creating visibility and maintaining transparency into all activities that contribute to the complete translational medicine plan for the key questions.
Coordinating the evaluation of proposals and ensuring delivery to appropriate collaboration team within expected timelines.
Elaborating and ensuring effective execution of a robust process for regular program and portfolio strategy reviews facilitated by Translational Medicine staff.
Provides scientific leadership in one or more critical areas and “chief of staff” support for TM Enabling Solutions leader to enhance operational connectivity bringing enriched operational expertise to enhance the overall delivery of the internal operations team.
Serving as TMES liaison to lead or support other strategic and process improvement initiatives affecting his/her portfolio area(s) as required.
Leads a team of Principal, Planning & Execution Leads in support of late stage asset development to provide a cohesive alignment across the late phase TM scientific environment.
B.S., M.S., PhD in a scientific discipline; PMP or equivalent experience is desirable.
10+ years pharmaceutical industry experience in a variety of operational/scientific roles minimum; 5+ years’ experience as a matrix leader in a highly diversified environment; 5+ years’ experience in direct line management of senior scientific/operational staff.
Thorough understanding of clinical data management and specimen acquisition and logistics practices with experience designing end-to-end workflows for optimized, repeatable execution.
Shapes strategic approaches to scientific delivery, utilizing sophisticated negotiation and scenario planning with resources both internal and external.
Works with a sense of urgency and experience managing multiple projects, building structure from ambiguity and helping teams to develop priorities.
Experience designing and leading complex, global projects comprised of virtual team members of diverse styles, driving to successful outcomes with and without direct management responsibilities.
Drives effective contract/fiscal management of project activities; experienced with the development of business cases for options based decision-making and effective vendor management for externally contracted work.
Skilled listener with ability to manage complex internal – up, across, and down the hierarchy - and external relationships through constructive conflict management; experience with third party governance oversight desirable.
Negotiates an enterprise (vs. functional) perspective across BMS.
Experienced in developing and implementing agile, creative solutions, utilizing direct and indirect resources, to solve business challenges within the line organization, across the company, and in partnership with external collaborators.
Strong communicator experienced with influencing and interacting at all levels including with senior scientific, operational or external thought leaders to drive connectivity and efficiency of collaborative research.