We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.

Apr 19, 2018
Aufgabengebiet Als Mitarbeiter im Außendienst mit dem Schwerpunkt Immun-Onkologie/ Pneumologie (m/w) für das Gebiet (Bremen, Osnabrück, Münster, Dortmund, Kassel, Bielefeld) sind Sie verantwortlich für den Verkauf unserer innovativen onkologischen Produkte. Sie beherrschen moderne Verkaufstechniken und betreuen und beraten niedergelassene Fachärzte und Fachärzte in Kliniken. Sie konzipieren selbstständig Vertriebspläne und innovative Veranstaltungskonzepte für Ihr Gebiet und setzen diese zuverlässig um. Sie beobachten und analysieren den Markt und reagieren umgehend durch die Anpassung Ihres Gebietsvertriebsplanes. Sie sind geübt im Umgang mit modernen Analysemethoden des Außendienstes und entwickeln sich gerne weiter. Zudem sind Sie für die Organisation, Einladung und Durchführung von Fortbildungsveranstaltungen in Ihrem Gebiet verantwortlich. Auch übernehmen Sie Standdienst und Kundenbetreuungen auf nationalen und internationalen Fortbildungsveranstaltungen und Kongressen. Anforderungsprofil Sie haben idealerweise ein natur- oder ein wirtschaftswissenschaftliches Studium abgeschlossen und sind Pharmaberater/in gemäß § 75 AMG oder Sie sind Geprüfte/r Pharmareferent/in und haben Ihre Fähigkeit zum wissenschaftlichen Arbeiten erfolgreich unter Beweis gestellt. Zudem haben Sie bereits Erfahrung in der Onkologie oder in anderen Specialty Care Bereichen. Sie bilden sich selbstständig kontinuierlich anhand neuester Studien in ihrem Indikationsgebiet weiter, um auf Augenhöhe wissenschaftliche Verkaufsgespräche führen zu können. Sie sind gewillt Ihre Verkaufstechniken ständig zu verbessern, Ihre analytischen und konzeptionellen Fähigkeiten stellen Sie in Ihrer täglichen Arbeit laufend unter Beweis. Zudem verfügen Sie über sehr gute Englischkenntnisse, so dass Trainings in englischer Sprache für Sie kein Problem darstellen. Mit den Analyse-Tools des Außendienstes gehen Sie sicher um, sehr gute PC-Kenntnisse runden Ihr Profil ab. Sie nutzen Ihr kommunikatives Talent, denken konstruktiv und strategisch, um neue Kundenkontakte aufzubauen und bestehende Geschäftsbeziehungen zu vertiefen. Mit Ihrer erfolgsorientierten, gut organisierten, eigenverantwortlichen und teamorientierten Arbeitsweise überzeugen Sie Ihre Geschäftspartner und tragen damit zur Erreichung der gemeinsamen Ziele innerhalb der Region bei. Der Umgang mit modernen Kommunikationstechnologien ist für Sie selbstverständlich. Räumliche Mobilität und Flexibilität sowie das Potenzial und die Bereitschaft zur Übernahme zukünftiger Führungsaufgaben im Marketing und/oder Vertrieb komplettieren idealerweise Ihr Profil. We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference. Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Bristol-Myers Squibb Munich, DEU
Apr 19, 2018
Aufgabengebiet: Responsible for using market research tools & analytics to answer key business questions for Oncology in Germany Collaborates with the Director, Oncology Business Insights & Analytics, Germany and peer counterparts to holistically answer questions for business stakeholders and supports the development of the integrated insights plan. + With the guidance of the manager, designs and implements primary Market Research engagements to deliver and help embed customer insights into decision-making for specific indications of the German Oncology franchise + Leverages wide variety of Market Research designs and analyses, and contributes to the deployment of Market Research & analytics approaches and techniques + With the guidance of the manager, designs and implements analytics, performance management reporting, and forecasting for planned and ad-hoc needs for specific indications of the German Oncology franchise + Liaises with Worldwide, other geographies and functional teams for efficient sharing and strategic adoption of learnings and capabilities Anforderungsprofil: Degree/Certification + BA/BS required + MBA or Masters (optional) Experience + 5+ years of working experience with strong Market Research and some analytical capabilities Competencies + Ability to leverage qual. / quant. MR capabilities to drive decisions + Strong written and verbal communication skills; ability to frame issues and present to business stakeholders + Software + Working knowledge of Microsoft Excel and PowerPoint required We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference. Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Bristol-Myers Squibb Munich, DEU
Apr 19, 2018
Global Clinical Trial-Submission Unit (GCT-SU) Specialist: Plans, coordinates, prepares and tracks the documents needed for initial submission (Start-up) and Substantial amendments (ongoing) of Clinical Trial Study package for all countries (except US) in compliance with the Country Regulatory Requirements, EU clinical Trial directive, related Guidance, and BMS processes. + Determines the appropriate submission strategy and consistency of the Clinical Trial Application (CTAp) across projects, studies and countries. + Effectively Leads Clinical Trial Application Tracking Meetings for the preparation of the CTAp dossier during start-up with cross-functional team and assure timelines and dossier quality are managed according to expectations. + Liaises with local and central teams and CRO, as required, to ensure that study start up activities are in compliance with study timelines and local regulations. + Optimally compiles and distributes the final Clinical Trial Application dossier (CTAp) and subsequent Substantial amendments to country applicants for submission to Ethics Committees and Competent Authorities. Communicates information and escalates issues, liaises with country offices and CSO, Operation Leads, Protocol Managers, Medical Monitor, QP and CROs (for outsourced studies) to ensure that study start up activities are in compliance with study timelines, BMS SOPs, local regulatory guidelines and regulations. Complies with the use and maintenance of the available planning & tracking tools (e.g. IRIS - HA submission and approval Tracking system) to generate reports and track the CTAp content and associated dates. Contributes to the Country Requirements Repository by collecting and sharing additional country requirements. Ensures Compliance with any revised Guidance & Regulations at EU and Country levels. Knowledge Desired: + Knowledge equivalent to that attained with a Bachelor's degree in Life Sciences, Allied Health, Pharmacy, Nursing, a Master's degree is preferable + 2-4 years of clinically related or relevant experience + Fluency in English Experiences Desired: + Experience in Clinical Trial Application preparation and coordination, regulatory or equivalent in the pharmaceutical industry. + Experience in effective implementation of clinical plans/documents and document preparation. + Demonstrated success in using oral and written communication and presentation skills to influence, inform or guide others. + Ability to work in multiple parallel projects and to share learning. + Previous experience working in an international team environment within a matrix organization. + Experience in managing technology for information and communication tool BMS BioPharma Behaviors required + Passion: We pursue excellence to help patients prevail. I set high standards for myself and others to win for our patients / I energize others / I strive to learn something new every day / I treat my patients, customers and colleagues with compassion, empathy and respect. + Innovation: We embrace new ideas. I challenge the status quo / I seek and share bold idea that help BMS win / I pursue and understand diverse perspectives outside of BMS / I encourage and have constructive debates / I embrace change to drive innovative outcomes / I rebound quickly and learn from my mistakes. + Accountability: We own our outcomes and the outcomes of others. I own BMS? Success by holding myself and others accountable / I share information in a transparent and honest way / I celebrate my successes and the successes of others / I coach and mentor others with good intent and purpose / I am inclusive and bring out the best in others / I understand what people do and the impact I have on them. + Speed: We act with urgency and agility. I work with a sense of urgency / I focus on what’s important / I consult with the right people to move quickly / I seek efficient, effective solutions / I quickly assess potential risks and rewards / I break silos and eliminate unnecessary rules / I make decisions with resolve and enable others to do the same. We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference. Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Bristol-Myers Squibb Braine L'Alleud, BEL
Apr 19, 2018
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 an Associate Director Quality Services based in Dublin or New Brunswick. The Associate Director Quality Services, External Manufacturing is responsible for leading a global organization, with reports in Dublin, New Brunswick and Switzerland that is responsible for implementing and maintaining systems to support ExM Quality Operations. This is inclusive of: + Documentation management and Control + Change Control + Complaints Management + Quality Council and quality metrics reporting + GMP Training + Training for External Manufacturing Organisation Manage Operations: + Documentation management: Ensure controlled documents are managed in a timely and efficient manner according to procedure + Lead the Change Control process for ExM: manage the change control programme ; ensure CC gatekeepers in place; provide training and support and monitor and track the appropriate metrics + Co-ordinate all cGMP training for the ExM organization + Facilitate and Lead ExM Quality Council meetings and Compile metrics to support local, and Global Quality Councils. Ensure all Quality metrcis and regulatory agency inspection metrics are tracked and reviewed. + Manage the complaint process within ExM and monitor the metrics associated with the closure of complaints and ensure trends across products are monitored and reviewed + Represent ExM at relevant Headquarters directive and policy reviews. Coordinate with Quality operations and other functions as necessary in ExM to present a consolidated review + Manage the review process for determining the compliance status of ExM with the “Global Communication of Inspection Observations” program. + Support the Quality Operations teams in preparation for regulatory inspections and corporate audits + Support the integration / harmonization of the Biologics and Pharma processes to ensure single process in place for relevant systems + Ensure processes in place to ensure effective review of training curricula across ExM globally and develop metrics and monitor training compliance across ExM Manage People: + Provide regular feedback and coaching to reports + Develops direct reports through coaching, mentoring, training and providing them with development opportunities + Build a team culture committed to high performance + Build effective working relationships both internally within ExM and within BMS Required Competencies: + Experience in developing and implementing Quality processes and systems within a site or External Manufacturing environment + Proficiency with the use of Global Systems (Trackwise, DCA and others) + Business Knowledge/understanding. + Leadership and management skills with strong influencing skills + Excellent Communication skills + Ability to handle multiple projects and meet tight timelines/deadlines. + Strong Technical writing ability. + Lead organization through change process Openness to change, receptive to new ideas Required Qualifications and Desired Experience: + BSc qualification, with at least 10 years relevant industrial experience. + In addition to the core competencies of Leadership, Communication skills, Teamwork, Problem Solving and a Commitment to Compliance, Continuous Improvement and the BMS BioPharma Behaviours, the job holder should have a strong technical background in Quality Systems and preferably have experience of dealing with CMOs across API and DP operations. We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference. Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Bristol-Myers Squibb Dublin Rd, Ireland
Apr 19, 2018
We invite a professional for Senior FP&A and BSF Manager role. Main tasks: + Ensure the achievability of the financial performance targets. + Drive financial awareness throughout the broader organization and managing change as it relates to financial issues. + Responsible for implementing the necessary controls to ensure a strong financial control environment, in line with corporate expectations. + Ensure the quality, accuracy and timeliness of the monthly reports. + Prepare, compile, review, communicate and present financial results to local and regional management. + Responsible for developing and managing best in class financial monitoring tools, and performing analysis on the key business metrics (revenues, costs and non-financial metrics). + Prepare and analysis of trends in revenue, expense, capital expenditure, working capital and other related areas of PnL, Balance Sheet and Cash Flow. Proactively report and identify variances and recommend actions for improvement. + Responsible for providing critical analysis and support to senior management on business decisions that impact the company's ability to fulfill its objectives + Always acting as a business partner and collaborate with business units to provide financial expertise on key business projects and decisions. + Takes broad business perspective when making decisions. Involves others in decision making when appropriate. Judgments are consistently accurate. + Anticipates and creates contingency plans to deal with possible problems and roadblocks. Looks ahead and develops strategies to combat potential problems. Rarely encounters issues that have not been anticipated. + Understands how events and changes in the internal and external environment will impact individuals, groups and the organization as a whole. Also understands how the organization interacts with external stakeholders and how that leads to results. + Ensure that all budget holders are fully aware of their individual responsibilities and take ownership of their financial results and the impact these have on the local performance targets. + Acts to promote a productive and co-operative environment by crossing boundaries to fulfill departmental objectives. + Responsible for implementation of SOX requirements in the Turkey. + Owns the implementation of the control activities in the Turkey. + Key contact to Process Owners within the Turkey. Communicates guidelines to Process Owners pertaining to the documentation of new and existing processes and testing of key controls. + Reviews documentation and narratives for completeness and standardization, manage resolution as necessary. + Periodically performs tests to evaluate the operating effectiveness of documented controls and design within Turkey. + Reviews and prioritizes remediation of deficiencies identified through testing procedures including those raised by internal and external audits. + Develops remediation plans including detailed procedures, resource requirements and schedule for the completion of necessary remediation activities. + Works with Process Owners to ensure remediation. + Facilitates and coordinates internal audit and internal auditor activities. + Maintains a strong relationship with the regional BCF team and market BCFs in CEE markets region. + Actively participates in regular teleconferences on internal controls and SOX + Maintains SAD report for the Turkey. + GOA Administrator: maintenance and review of financial limits delegations. + Constant process analysis and improvement proposals in the country. + Redesign of processes to streamline the processes but secure necessary controls are in place + Provides policy and procedures guidance, maintains full understanding of the accounting policies and procedures, manages all necessary trainings + Reviews corporate policies and proposes changes to Local policies, procedures or processes. Keeps archive of original local procedural documents. + Controls over Masterfiles Maintenance. + T&E reports reviews across the country. + Internal and 3rd party audit coordination (main contact, before, within and after audit). + Acts as advisor in internal control issues and in process redesign + Contract management including finance technical review of contracts and of purchase requisitions when appropriate + Investigations of invoices discrepancies to PO when appropriate + Coordinates post close activities including post close meetings, balance sheet flux analysis, project variances and cost center key variances + Seats at compliance committee + FCPA reviews coordination and training including reviews of activity/event reportsQualifications: + Min 5 years of audit/finance/accounting experience. + University degree in Business Administration, Economics, Engineering. CMA, CPA, MBA will be preferred. + Deep understanding of audit processes and internal controls + Strong written and oral communication skills. Ability to communicate to diverse audience at multiple levels with the company. + Ability to interact with Senior Management. Strong presentation skills. + Ability to be both clear and concise. + Ability to manage projects from beginning to end, be well organized, and have a proven track record of meeting or exceeding project deadlines. + Strong Excel skills with proficiency in Microsoft office applications. Knowledge of Hyperion, SAP/SAP sub-systems (RPM, BI)S + Strong analytical skills + Fluent in English We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference. Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Bristol-Myers Squibb 415 PO Box, Lodi, NJ 07644, USA
Apr 19, 2018
This position is for Eliquis, Specialty Retail Sales Representative located in Traverse City, MI. Sales candidates must be able to understand and apply knowledge of pertinent health care industry trends, sales trends, market dynamics, competitors, applicable laws and regulations, and health care payer environment, and analyze each of these factors in the development of actionable business plans and in daily execution of sales calls, within compliance guidelines. Develop and implement territory plans that identify and prioritize activities and resources to accomplish short and long-term sales and business goals. An accountable self-starter who can develop deep customer insights, build and maintain strong professional relationships with physicians (primary care and specialists), pharmacists, nurses, office staff and other health care providers in the patient care continuum. Appropriately leverage resources and apply sound account management skills and perseverance to secure customer access and maximize selling time. Utilize deep understanding of disease states, BMS products, and as appropriate, relevant competitor products to tailor interactions with specific customers. Excellent communication skills- verbal and written- including the ability to present to groups. Collaborate across the Cardiovascular sales organization, CV Institutional Sales Representatives, cross functional teams and where appropriate alliance partners. Work within matrix team to identify opportunities and develop appropriate tactics and strategies. Drive market share growth and maximize sales performance within the indicated use and approved patient types. Possess a high level of ethics and integrity. Adhere to all applicable laws, regulations, and BMS policies. **Requirements:** Bachelor's degree or equivalent is required. Minimum of 5 years of sales experience is preferred. Demonstrated success in medical profession is advantageous. A strong customer focus and analytical skills to identify and prioritize business opportunities is required. Proven track record in delivering results and developing innovative approaches in evolving markets. Previous new product or concept launch experience desired. Ability to learn, apply, and grow disease state knowledge is required. Ability to effectively communicate technical and scientific product and disease information to a variety of customers in multiple settings. Technical aptitude to learn and apply new technologies to manage a territory is required. Management retains the right to change the job specifications (may include grade level and salary range) and provisions of this job as appropriate. In addition, we reserve the right to place candidates in positions at levels commensurate with their depth of knowledge around the following competencies: Product and Disease State Knowledge, Market and Industry Knowledge, Sales Resource Utilization, Selling Skills, and Business Planning. As this position requires operation of a Company-provided vehicle, offers of employment are contingent upon the candidate meeting the requirements of “Qualified Driver,” as determined by the Company in its sole discretion, including but not limited to the following: 1) at least 21 years of age; 2) a driver’s license in good standing issued by your state of residence; and, 3) a driving risk level deemed acceptable by the Company. Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Bristol-Myers Squibb Traverse City, MI, USA
Apr 19, 2018
We are seeking an individual with knowledge and experience in contracting, to join the Contract Management team in Central Clinical Planning and Solutions. This individual will also interact with contracting professionals at research sites to discuss sponsor and institutional perspectives on various contract terms to improve understanding, relationships and the quality and timeliness of our contracts. Key responsibilities include: + Execution of Master Agreements with Academic Institutions + Contribute to development and maintenance of template language including associated fallback language for various contract types + Escalate to appropriate BMS colleagues when a significant risk to the business is identified + Negotiate contract terms and conditions with sites/investigators/institutions + Make appropriate business decisions within their scope or authority, and communicates to internal project leaders on the issues and risks associated with contracting decisions + Ensure contracting compliance and appropriate prioritization and execution aligned with the clinical trial Book of Work. Qualifications: Knowledge equivalent to that attained with a Bachelor’s degree and 3+ years direct contracting experience, preferably within the Pharmaceutical industry; or Master’s degree and 1 year contracting experience. Outstanding written and verbal communication skills with a strong customer focus. Skilled in conflict resolution with the ability to resolve problems independently. Ability to multi-task within and across projects, prioritize and manage timelines effectively. Ability to sustain high levels of performance in a constantly changing environment. Innovative, proactive, and motivated, with a focus on continuous improvement and a strong desire to succeed. Ability to think strategically and implement contract simplification. Strong project management skills, highly inquisitive, externally-focused, creative problem-solver. Ability to establish key relationships and work effectively with cross-functional teams and external stakeholders. Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Bristol-Myers Squibb Princeton, NJ, USA
Apr 19, 2018
BMS Global Internal Audit & Assurance is recruiting the best talent to execute a dynamic risk-based audit plan that identifies value-added recommendations to enhance Company processes and controls. The Senior IT Auditor will work in a team environment to audit IT activities including general computer controls, system and data security, outsourcing partners, pre- and post-application implementations, social media, cloud computing, mobile devices and emerging and changing risks. Audits include leveraging data visualization tools in the planning, execution and reporting phases to drive efficiencies and effectiveness. In addition, depending on the candidate’s background and interests, opportunities exist to become a data analytics super user giving the department’s transformative use of data analytics as well as work on non-IT audits covering financial, compliance, strategic and operational risks. Throughout the audits, the Senior IT Auditor will have the opportunity to interact with Company senior management and enhance oral and written communication skills. BMS Global Internal Audit & Assurance focuses on individual and team development and therefore the Senior IT Auditor will participate with the team in at least two weeks of training annually, in addition to regular departmental meetings that include sharing best practices. BMS Global Internal Audit & Assurance is a source of key talent in the Company. Graduates from BMS Global Internal Audit & Assurance hold key leadership roles in the Company, including within IT, Finance and business unit operations. In this role, the Senior IT Auditor will receive broad exposure across BMS’ operations. Given the exposure and experience a Senior IT Auditor receives, this position is generally a stepping stone to a manager role upon roll out from the department. BMS Global Internal Audit & Assurance’s mission is to: • Provide independent, objective assurance and advisory services designed to add value and improve the Company’s operations. • Support BMS’ business objectives by bringing a systematic, disciplined approach to evaluate and improve the effectiveness of risk management, control and governance processes. • Develop future leaders by providing dynamic experiences to expand global business knowledge and networks and by enhancing communication, technical and people management skills. RESPONSIBILITIES: 1. Participates in planning activities to develop audit scopes. 2. Design audit programs and test plans to determine the adequacy and effectiveness of internal controls and compliance with BMS policies and procedures with minimal guidance. 3. Interview select personnel and document and assess business processes and information systems to determine the adequacy of the control environment with minimal guidance. 4. Test information technology application and system processes and controls with minimal guidance. 5. Demonstrate proficiency in applying information systems audit principles, skills and techniques. 6. Understand financial, operational and compliance risks 7. Understand IT risks with greater depth and expertise to identify root cause and preventative actions. 8. Understand, develop and implement data analytics projects on-going or planned within the department with minimal direction. 9. Apply innovative solutions to related issues with strategic, operational, compliance and IT audits as well as data analytics project implementation activities. 10. Be able to provide guidance and leadership during execution and coordination across projects and processes. 11. Identify value-added recommendations and align with management on corrective actions to address identified risks. 12. Present audit results to management. 13. Prepare audit reports detailing recommendations to strengthen and improve the control environment. Maintain work papers in accordance with BMS Global Internal Audit & Assurance and IIA Standards. With minimal guidance. 14. Participate in department projects to drive value (Audit Newsletter, Audit Lessons Learned, etc.). **QUALIFICATIONS:** **EDUCATION** **Degree** - BS/BA, MIS or equivalent, MBA or other advanced degree desired. **Certification** – Professional certification required, CISA or equivalent. CPA a plus. **Language** – English required, fluency in additional language(s) a plus. **Regulations** – Knowledge of applicable business laws and regulations required. **PRIOR EXPERIENCE** 3-5 years of relevant prior public accounting experience or internal auditing or quality assurance group experience. **TECHNICAL SKILLS** **Oral/Written** – Ability to present concisely in oral and written format to all levels of management. **Process Design and Analysis** – Ability to analyze complex processes and to determine the efficiency and effectiveness of the process and related controls. **Computer Skills** - Working knowledge of MS Office Suite (Excel, Word, etc.) required. Experience in data visualization tools (e.g., Tableau) or Audit Command Language (ACL) a plus. **Information Systems –** SAP experience preferred. **Security Skills** – Experience with the security of operating systems, applications and telecommunications preferred. **OTHER** **Travel** - Ability to travel 0% - 10% of the time. **Location -** Position will be based in Nassau Park, NJ. **PERSONAL CHARACTERISTICS:** + Drives performance. + Organized and able to multi-task. + Prioritizes and executes assigned tasks effectively and efficiently. + Learns quickly and adapts to change. + Action oriented. + Demonstrates potential to lead. + Faces difficult situations with integrity and tenacity. + Meets challenges with enthusiasm. + Works well in a team environment and builds strong relationships. + Supports fellow team members to meet shared goals. + Adheres to the highest ethical standards and values. + Challenges self to learn and improve. Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Bristol-Myers Squibb Princeton, NJ, USA
Apr 19, 2018
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. In this role, the individual will have the responsibility to lead the clinical pharmacology development of Oncology/Immuno-Oncology programs in clinical development and life cycle management. The individual will be responsible for the creation and design of the Clinical Pharmacology and Pharmacometrics plan in clinical development and life cycle management and contribute to the Clinical Pharmacology and Pharmacometrics aspects of exploratory clinical development plans. This individual will also contribute to the design, planning, execution and interpretation of Exploratory Clinical and Clinical Pharmacology studies. In addition, this individual will be expected to perform pharmacokinetic and pharmacodynamic modeling and simulation, and support and implement model-based drug development efforts throughout clinical development. This individual will contribute to the Clinical Pharmacology components of regulatory submissions and be responsible for responding to regulatory authority questions, in person and in written form. The individual may represent the department at the development matrix team level as the Clinical Pharmacology expert. Requirements for the position include a Ph.D. in pharmacology or pharmacokinetics or related discipline, or a PharmD with a clinical pharmacology research fellowship. A minimum of 5 years experience gained through direct industry experience in Clinical Pharmacology/Pharmacokinetics is required. Demonstrated experience in preparing regulatory submissions, including NDA or BLA, as well as INDs. Experience responding to regulatory questions related to clinical pharmacology and pharmacokinetics/pharmacodynamics. Application and knowledge of current practices and issues in the following areas for multiple projects: clinical pharmacology, PK/PD, pharmacometrics, ADME, bioanalytical, biopharmaceutics, regulatory, non clinical metabolism, pharmacokinetics, pharmacology and toxicology. Direct experience designing, conducting and interpreting studies in population PK, PK PD correlations, modeling and simulation utilizing specialized software such as NONMEM, R/S-Plus, ADAPT, Gastroplus or Simcyp is highly desirable. Strong communication and project management skills required. Experience in biologics, and oncology, is a plus Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Bristol-Myers Squibb Princeton, NJ, USA
Apr 19, 2018
Purpose/Objective of the job: The Quality Responsible Person is responsible for ensuring that a quality management system is implemented and maintained for the distribution activities with BMS products in identified Markets in EMEA. Expected area of competence: + Lead and influence a dynamic and diverse staff of Quality professionals in distribution and ensure the proper skill set and development for the team aligned with BMS strategic. + Lead the implementation of the Quality Management system, including the organization and the documentation and tracking the completion milestones. + Deal with complex issues using critical analysis and develops ethical, reasoned solutions to meet both business and regulatory requirements. + Influence and affect the organization by communicating quality issues and decisions which impact the business. + Ensure compliance of Distribution partners to all BMS requirements including distribution and transportation. + Ensures continuous improvement activities for more effective Quality systems across the organization. + Active participation to company business growth objectives for Quality alignment. Key Responsibilities and Major Duties Ensure that a Quality Management System is implemented and maintained in the local entities in the Cluster, including: + Guidance for Quality System Documentation, procedures and records maintenance + BMS Global Procedural documents assessment and implementation + GMP/GDP and Local regulations impact assessment and implementation + Ensure that responsibilities and tasks assigned to the Quality Responsible Person are correctly managed in the Cluster local markets + Leadership for Training of personnel: initial and continuous training programs are implemented and maintained. + Guidance for customer Complaints handling, for both quality and logistics complaints. + Develop Self-inspection program and conduct Self-inspections, and follow that necessary corrective measures are put in place + Ensure the system to investigate Deviation and manage CAPA + Maintain Change Control management system + Co-lead the Quality Council in the local Market + Implement adequate action plans for Quality metrics achievement, when necessary Quality Operations: + Develop, implement and maintain the system for Distribution Suppliers qualification and management + Harmonized practices between the Distribution partners and ensure that BMS and local HA requirements are included in the Quality Agreement and observed. + Handle compliance/quality issues with the impacted Distribution partners, liaise with the global functions + Attend the fact finding when required and define the adequate action plans in the Cluster + Coordinating the recall operations and mock recalls in the Cluster + Coordination of Quality Risk Management Facilitate BMS requirements are implemented by the Distributors in the Cluster: + Warehousing facilities + Secondary packaging facilities (when required to be used for exceptional operations) + Transportation processes + Participate in the periodic Business Review with the Distributors Inspections and Regulatory Surveillance + Readiness for HA inspection in the Cluster local entities, and support during the HA inspection + Support the Global Quality Audits in the Cluster local entities Supervisory Responsibility of the Quality Responsible Person in the local entities of the Cluster (Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned) Key Stakeholders/Contacts – describe this position’s key internal matrix relationships and key external stakeholders/clients + Internal - Regional and Global Quality Functions, Global Logistics, GRS, Business organizations: Commercial, Brand teams, Customer Service, Medical + External - Government Regulatory Authorities and Third Party Suppliers and Vendors We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference. Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Bristol-Myers Squibb Cham, CHE
Apr 19, 2018
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 an Inventory Controller based in Plaza 254, Dublin. The inventory controller is responsible for management, oversight and reporting for all External Manufacturing (ExM) owned inventory at internal (BMS) and external (CMO) locations globally. Responsibilities: + Takes responsibility for the management of all types of inventory owned by ExM. + Determines, implements and maintains the appropriate inventory control parameters in the SAP system. + Responsible for ensuring financial provisions are in place and accurately maintained. + Responsible for the management of excess and obsolete inventory. + Implements a cost recovery program for excess inventory. + Proactively identifies inventory issues and implements solutions after consultation with the relevant business leaders. + Trouble shoot cost risks to the business and develop process and control points to mitigate under GMP guidelines and practice. + Meet Inventory Reporting requirements at local, regional and global levels. This includes daily, monthly and projected inventory levels vs. actual and budgeted inventory levels across all inventory types. + Participates in inventory audits and cycle counts as required. Performs investigations and gap analysis as necessary. + Reviews and challenges business processes. Develops, implements and enforces Standard Operating Procedures as necessary. + Conducts thorough and careful analysis of data, gathers critical information, effectively allocates/reassesses required organizational resources and delivers quality solutions to critical business tasks. + Establishes strong working relationships with key stakeholders. + Has oversight responsibility to ensure that ExM inventory data is maintained through robust processes. Required Competencies + Strong background in inventory management in complex ,multi-site organizations + Excellent Analytical and PC application knowledge + Excellent verbal and written communication and presentation skills. + Ability to prioritise, organise and manage multiple tasks to tight deadlines. + Understands BMS Supply Chain, products and markets. + Good understanding of business specific organizations, functions and business support systems (manufacturing, packaging, artwork, regulatory, marketing, quality control/quality assurance and supply chain) + Ability to work effectively with diverse groups and organizations + Capable to interact with key decision makers in Manufacturing Technology, Quality, Supply Chain, Procurement, Manufacturing, Finance, Legal, EHS. Required Qualification(s) and Desired Experience + Understanding of pharmaceutical product lifecycle and obsolescence + SAP and SAP Business Warehouse system knowledge. + Knowledge of cost and/or inventory accounting principles + Degree in Supply Chain Management or Finance + APICS CPIM + Understanding of pharmaceutical manufacturing operations within the overall business organization and structure + Enhance the ability to work and manage in a complex matrix organization + Interested? Apply now by clicking the Apply button, or email me at anca.popa@bms.com for more information. We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference. Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Bristol-Myers Squibb Dublin Rd, Ireland
Apr 19, 2018
The role of the Associate Scientist/Engineer is to support the Investigation Program Group. Reports to Investigation Program Group Lead, Syracuse. **Duties/Responsibilities:** • Be a champion for the Global Investigation Program in Syracuse. • Represent Syracuse on Global Investigation teams in collaboration with Syracuse Quality Assurance. • Train global investigators for the site. • Ensure investigations are performed in accordance with global directives, site procedures and with high standards. • Coach lead investigators through the course of their certification and subsequent investigations, as needed. • Improve the investigation and CAPA business processes to reduce rework, cycle times, and repeat quality events by improving CAPA effectiveness. Use CAPA effectiveness to improve quality event metrics. • Assist with metrics and trending for quality events in collaboration with Quality Assurance. • Collaborate with cross functional teams and representatives of other organizations outside Manufacturing Technology as well as other groups within Manufacturing Sciences and Technology. The Associate Scientist/Engineer works independently and delivers results in line with objectives. The Associate Scientist/Engineer also collaborates with other groups. **QUALIFICATIONS** **Specific Knowledge, Skills, Abilities, etc:** Knowledge of several areas of commercial-scale biologics manufacture and quality systems are needed, including process engineering, process equipment design, documentation, compliance investigations, regulatory submissions and inspections. Experience in operational excellence, project leadership, data analysis, document review and presentations are desired. **Education/Experience/Licenses/Certifications:** A B.A./B.S./M.S./Ph.D. in a technical discipline such as Biology, Biochemistry or Engineering with 2 to 5 years experience in commercial biologics manufacturing. **Physical Demands:** This position is office-based with occasional visits to manufacturing suites, which require an appropriate level of personal protective equipment (PPE). Depending on the work demands, office-based work requires sitting. This position is based indoors and you will primarily be working with others, but also independently and alone at times. This position is a team-based position that may require work at weekends and holidays as well as occasional travel. **Work Environment:** + Office space + Manufacturing space + Inside Work + Working Alone + Working with/around others + Extremes (Heat/Cold) + Dust/Wet + Chemicals **Travel:** This position requires up to 10% of travel to other internal and external manufacturing sites, vendors and technical conferences or trade shows Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Bristol-Myers Squibb Syracuse, NY, USA
Apr 19, 2018
This position is for Eliquis, Senior Specialty Retail Sales Representative located in Pikeville, KY. Sales candidates must be able to understand and apply knowledge of pertinent health care industry trends, sales trends, market dynamics, competitors, applicable laws and regulations, and health care payer environment, and analyze each of these factors in the development of actionable business plans and in daily execution of sales calls, within compliance guidelines. Develop and implement territory plans that identify and prioritize activities and resources to accomplish short and long-term sales and business goals. An accountable self-starter who can develop deep customer insights, build and maintain strong professional relationships with physicians (primary care and specialists), pharmacists, nurses, office staff and other health care providers in the patient care continuum. Appropriately leverage resources and apply sound account management skills and perseverance to secure customer access and maximize selling time. Utilize deep understanding of disease states, BMS products, and as appropriate, relevant competitor products to tailor interactions with specific customers. Excellent communication skills- verbal and written- including the ability to present to groups. Collaborate across the Cardiovascular sales organization, CV Institutional Sales Representatives, cross functional teams and where appropriate alliance partners. Work within matrix team to identify opportunities and develop appropriate tactics and strategies. Drive market share growth and maximize sales performance within the indicated use and approved patient types. Possess a high level of ethics and integrity. Adhere to all applicable laws, regulations, and BMS policies. **Requirements:** Bachelor's degree or equivalent is required. Minimum of 5 years of sales experience is preferred. Demonstrated success in medical profession is advantageous. A strong customer focus and analytical skills to identify and prioritize business opportunities is required. Proven track record in delivering results and developing innovative approaches in evolving markets. Previous new product or concept launch experience desired. Ability to learn, apply, and grow disease state knowledge is required. Ability to effectively communicate technical and scientific product and disease information to a variety of customers in multiple settings. Technical aptitude to learn and apply new technologies to manage a territory is required. As this position requires operation of a Company-provided vehicle, offers of employment are contingent upon the candidate meeting the requirements of “Qualified Driver,” as determined by the Company in its sole discretion, including but not limited to the following: 1) at least 21 years of age; 2) a driver’s license in good standing issued by your state of residence; and, 3) a driving risk level deemed acceptable by the Company Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Bristol-Myers Squibb Charleston, WV, USA
Apr 19, 2018
Work closely with Translational Science’s histology/pathology and radiology imaging groups to uncover exiting functionality gaps and define future needs for IT / Informatics capabilities/systems in support of Translational Medicine’s imaging strategy. · Build relationships with key stakeholders and maintain a current, comprehensive understanding of their business objectives. · Collaborate with stakeholders to develop and maintain a long-term information management strategy that meets those business objectives and anticipates future needs. · Active participant in cross functional teams to develop business case artifacts, presenting them to leadership to secure project funding. · Work with cross functional teams to define project schedules, monitor progress throughout project lifecycle and hand off to support teams at project completion. · Member of the IT/Informatics Imaging team developing/updating the Imaging roadmap. **Skills Required** · Expertise with workflow, image analysis tools and technology for histology/pathology and/or radiology imaging · Expertise with histology/pathology and/or radiology imaging systems and underlying technology platforms, including acquisition, storage, management, retrieval and analysis functionality · Prior experience with the operation and performance of cloud based imaging systems and underlying technology platforms · Prior experience with Machine Learning (AI) as applied to medical image analysis · Knowledge of medical imaging data formats (Aperio, .sis, .svs, .im3, DICOM, etc.) and related analysis/processing algorithms · Hands-on experience with software development methodologies and lifecycles, and supporting documentation · Excellent written and oral communication skills · Ability to work well in a highly matrixed organization, well under pressure, and on concurrent multidisciplinary projects **Minimum Qualifications:** · Master's Degree (or higher) in Biomedical Engineering, Bioinformatics, Life Sciences, Information Technology or related discipline · 5+ years of domain related experience in a clinical imaging (histology/pathology and/or radiology) healthcare IT setting (central lab, core lab, CRO, hospital, pharma, etc.) · Appropriate education and/or experience may be substituted on equivalent basis Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Bristol-Myers Squibb Princeton, NJ, USA
Apr 19, 2018
Bristol-Myers Squibb is a global biopharmaceutical company focused on discovering, developing and delivering innovative medicines for patients with serious diseases. Our medicines are helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience, fibrosis and others. We have built a sustainable pipeline of potential therapies, and are leveraging translational medicine and data analytics to understand how we can deliver the right medicine to the right patient at the right time to achieve the best outcome. Bristol-Myers Squibb gives you the opportunity to learn and grow professionally alongside smart, creative and talented colleagues who are committed to helping patients battle serious diseases. Doing amazing things with people you like and admire isn’t something you can find just anywhere. We believe in a Total Rewards experience that enriches your life today and engages and empowers you to save, perform, grow, and build toward all of your tomorrows. We foster an energizing work experience, that through your choices, education and access, sustains our environment of well-being, individual accountability, productivity and safety. We now have an opening for a Product Design Senior Engineer for Medical Device / Combination Products. Specific responsibilities include: + Serve as lead design engineer in development projects, perform and coordinate design reviews and assess technical solutions. + Generate new drug delivery device concepts, documented by hand sketches, CAD models and/or text descriptions. + Build “looks like” (form) and “works like” (function) prototype models. + Plan, conduct, analyze and document human factors activities. + Design experiments using DOE methodology and analyze the test results using statistical tools. + Lead efforts in creating custom methods and equipment for testing components, delivery devices and systems. + Identify, select and manage external resources (device vendors, service providers and third-party manufacturers). + Ensure all development activities are executed in alignment with design controls, with the proper documentation for traceability. + Contribute to the preparation of regulatory submissions (per 21 CFR 820.30, 21 CFR part 4). + Liaison with the Intellectual Property department to ensure FTO clearance and intellectual property protection. + Collaborate with other teams at functional, departmental and divisional level to ensure robust definition of product requirements. + Maintain a high state of awareness of the competitive landscape and state-of-the art in drug delivery and identification of trends in clinical practice and regulatory landscape. + Participate in the development and evolution of the company’s CAD infrastructure, design tools and product development process. Qualifications: + BS degree in Mechanical Engineering, Product Design, Industrial Design or relevant engineering discipline. Advanced degree a plus. + Minimum of 8 years of product development experience with a strong track record of achievement. Direct experience with medical devices, combination products, and/or drug delivery technologies a plus. + Strong technical skills and creative ability a must. Mastery of the fundamentals of engineering, with a focus on mechanisms, materials, fluidics and physics. Knowledge of manufacturing processes such as machining, metal forming, injection molding and assembly operations. + Ability to generate technical sketches and 3D CAD models/renderings needed. Comfortable building and testing prototypes. + Ability and willingness to generate documentation (test protocols, completion reports, product/process specifications, invention disclosures, etc.). Experience with design control in a medical device FDA regulated design environment is preferred. Strong communication skills and ability to work in a collaborative team environment a must. + Pro-active, self-motivated personality. Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Bristol-Myers Squibb New Brunswick, NJ, USA
Apr 19, 2018
This Engineering/Scientist role will be responsible for supporting the development of new drug products for both oral solids and parenteral, biologics based products. The successful candidate will collaborate with scientists across product development using primarily using their expertise in process analytical technologies (PAT) and chemometrics to support formulation development and process design; while balancing speed with risk. The successful candidate has a strong understanding of process analytics, analytical method development, laboratory and/or manufacturing experience in drug product processing, understanding of formulation science fundamentals, and strong collaboration and communication skills. The individual works well with people from other disciplines and thrives in a multifunctional team environment. A high level of energy and strong work ethic is critical to success. The successful candidate has expertise in one or more of the following areas: Process analytical technologies, analytical instrumentation, chemometrics, process modeling, OSD formulation development, and scale-up and transfer. **Responsibilities:** + Primary responsibility to develop innovative analytical tools (PAT) that provide drug product formulation and process understanding. Use Raman, IR, FT-Near Infrared, Particle sizing and other in-process type technologies to address the risk analysis of the process or product and or implement controls to enhance robustness. These methods can encompass on-line and off-line + Accountable for providing innovative solutions and analyses which provide key insights and process knowledge for development, including scale-up and process optimization studies for projects within the portfolio. + Accountable for collaborating within project teams to provide innovative approaches to help solve challenging problems encountered to support formulation development and process optimization studies conducted by development scientists and engineers. + Facilitate problem solving using scientific, engineering, and analytical techniques to support drug product development from early development to product launch as a member of a multidisciplinary project team. + Partners with other Functions within Drug Product Science and Technology, and across Product Development to evolve, integrate and optimize support to create a world-class development function. + Responsible for willingly and enthusiastically working at the bench to solve challenging pharmaceutical development problems using their expertise in a particular area of development engineering and through demonstrated broader understanding of engineering techniques and how they may be applied to cross functional development challenges. Can be relied upon to work independently to develop and validate techniques within their area of expertise. + Accountable for identifying opportunities and/or implementing solutions to improve efficiency, productivity, quality or reduce costs, operate in accordance with safety and compliance standards (e.g., GMPs, facility, division and department SOPs). Demonstrates capability to influence teams (e.g. not just attend meetings, but offer suggestions) and seeks leadership opportunities. + Responsible for actively collaborating with other key scientists within the team. Expected to consistently display a can-do attitude and demonstrate the willingness and capability to adapt and grow within a complex and changing environment. **Qualifications/Requirements:** + Ph.D. or Masters in scientific or engineering discipline is required. Practical experience directly relevant to the role is critical to success and minimum degree requirements change relative to experience. + 0-5 years of experience in drug product development and problem solving in the pharmaceutical industry. + Excellent interpersonal, collaborative, team building, and communication skills to ensure effective collaborations within matrix teams. Demonstrated performance against cooperation principles and enterprise mindset. + Demonstrated experience in building relationships and using influence. Can establish credibility and earns respect with a diverse set of internal and external stakeholders including manufacturing partners and other functional managers. Is able to “get things done” without compromising principles. A high level of energy and strong work ethic is critical to success. Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Bristol-Myers Squibb New Brunswick, NJ, USA
Apr 19, 2018
Partner with scientists to develop industry leading data science, machine learning and visualization platforms for Translational Medicine. Serve as a bridge between scientists in various translational medicine areas and the technology teams building data integration solutions and enterprise business intelligence and analytics functions. + Build strong partnerships and trust with scientists in Translational Medicine. Understand scientific requirements and data analysis needs at a detailed, project-specific level. + Help TM scientists with creation of data analysis solutions including selection of right tools for the datasets, selecting appropriate platforms for data analysis, and designing meaningful dashboards + Help articulate needs and solutions for reproducible research platform + Understand the applicability of Machine Learning on broad range of translational medicine problems and help develop a platform strategy to comprehensively address these needs + Use understanding of the TM scientific strategy to drive the development of realistic and actionable multi-year strategic digital capability roadmaps, informed and prioritized by business and IT in an enterprise context. + Lead the prioritization and development of strong and clear business cases for digital capability investments in support of the roadmap and aligned with the platform strategy. + Articulate the need of TM business functions to appropriate software engineering, data management, and architecture groups to ensure that integrated, scalable and scientifically robust solutions are implemented + Own the ultimate delivery of value to the scientific user base. Responsible for building and managing effective business partnership at all levels during project execution. Fully accountable for delivering the value proposition of IT. + Provide project management leadership where necessary. + Provide thought leadership around data science within the IT organization Educational Qualifications: + MS or PhD in data sciences, biological mathematics, computer science, applied mathematics, biomedical informatics, public health, nursing, basic sciences or a related field Desired Experience + At least 5 years of experience in implementing applications of machine learning to translational medicine + Deep understanding of biomedical data, including data from early stage discovery research, clinical research data, clinical data, and high-volume biomarker data ( genomics, proteomics, imaging, cell-based assays, etc.). Understanding of approaches/challenges to integrating clinical and biomarker data is critical + Experience in creating data analysis pipelines (using Pipeline Pilot, KNIME, Python, etc.) for processing of biomedical datasets. + Experience with Spotfire, Tableau etc. for data analytics and dashboards + Understanding of industry standard tools for data analysis (R, SAS, MatLab, etc.) + Understanding of various public biomedical data initiatives (NCI Cancer Research Data Commons, GA4GH, etc.) + Ability to work in a highly matrixed organization + Excellent communications skills Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Bristol-Myers Squibb Princeton, NJ, USA
Apr 19, 2018
Partner with Translational Bioinformatics within Translational Medicine and IT to develop strategy for bioinformatics infrastructure and computational support. Work closely with the software and data architecture groups to ensure robust architecture for integration and access for large, diverse and high velocity scientific datasets. Exceptional communication and relationship building skills to establish strong partnership, trust and rapport with senior leaders and scientists in the Translational Bioinformatics (T-Bio) group within Translational Medicine organization. Owns the IT business relationship with T-bio + Recognized as a thought leader and trusted advisor in Translational Medicine IT and specifically, Translational Bioinformatics IT: Influences the strategic thinking of senior business leaders, and helps business leaders to include future digital capabilities into their planning; perceived as a capable leader who plans and delivers digital capabilities, safeguards their digital assets and supports their strategic goals. + Drive the development of realistic and actionable multi-year strategic digital capability roadmaps, informed and prioritized by business (T-bio) and IT in an enterprise context. + Lead the prioritization and development of strong and clear business cases for digital capability investments in support of the roadmap and aligned with the platform strategy. + Articulate the need of T-bio business functions to appropriate IT groups including IT infrastructure, domain/enterprise architecture and Integrated Data Management group to ensure that integrated, scalable and scientifically robust solutions are implemented + Drive change - ensures effective planning, execution and communication of business change management to support digital capability investments, including business process changes to achieve maximum value from investments. + Build proposals for technology capabilities supporting T-Bio group that meet near-term and long-term needs, and define detailed requirements for those capabilities. + Own the ultimate delivery of value to the scientific user base. Responsible for building and managing effective business partnership at all levels during project execution. Fully accountable for delivering the value proposition of IT. + Provide project management leadership where necessary. + Empowers build & run teams: Understands IT business partner accountabilities throughout the plan/build/run cycle, and builds empowered and trusting partnerships with IT build & run team members at all levels. + Ensure that the build & run teams make the right trade-offs between speed, quality and cost and that the value is being captured from the entire lifecycle of the IT investment **Educational Qualifications:** + MS or PhD in Bioinformatics with deep systems-level expertise in bioinformatics software and infrastructure **Desired Experience:** + At least 5-years of experience in managing bioinformatics systems + Experience with High Performance Computing (on-prem and cloud) + Expertise with commercial and/or open source bioinformatics platform enabling platforms such as Galaxy, SevenBridges, DNANexus, etc. + Understanding of translational “big data,” including genomic, proteomic and metabolomics data, their analysis pipelines and infrastructure required to support these + Experience in Bioinformatics data integration platform such as tranSMART, cBioPortal etc. + Ability to work in a highly matrixed organization + Excellent communications skills Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Bristol-Myers Squibb Princeton, NJ, USA
Apr 19, 2018
治験を適切に実施できる医療機関/治験責任医師の情報を収集、選定する。 GCP、ガイドライン、社内/治験実施医療機関のSOPに従い、サイトマネジャーと協働し、治験依頼、手続き書類を作成、治験費用および契約の交渉、契約締結する。 スタディチームメンバーと協働し、治験開始に必要なドキュメント、資料を作成する。 治験実施医療機関(担当医師、治験スタッフ)と協議し、適切に臨床試験が実施される体制を確立する。 治験に関連した必要な資料を提供し、説明する。 業務委託スタッフの各種業務の進捗を把握、管理し、臨床試験実施における治験手続全般をコーディネートする。 担当医師、治験スタッフとコンタクトを取り、タイムラインに沿った評価可能症例を確保し、進捗を管理する。 スタディチームメンバーと治験実施医療機関における情報を共有し、担当医療機関における問題を事前に特定、解決案を提案、実行する。 治験実施医療機関からの問い合わせ、質問に対して自主的に回答し、解決を図る。 治験実施医療機関において適切に治験が実施されているか確認する。必要に応じ、治験スタッフおよび/あるいはスタディチームメンバー(Outsourceモニターを含む)にトレーニングを提供する。 逸脱発生時の再発防止策を検討し、適切に記録(issue report、follow-up letter、モニタリング記録等)を作成する。 治験実施医療機関レベルの潜在的なリスクを特定し、解決策を提案する。 治験データがタイムリーに電子症例報告書に入力されていること、およびそのデータの品質を確保する。 適切かつタイムリーにモニタリング報告書および関連文書を作成、提出する。 モニタリング業務の効率化/標準化を図ることで業務を簡素化するとともに、求められる質を維持するためのツール作成やトレーニングの実施等の方策を講じる。 予算およびリソースの有効活用を最大化し、目標達成に向けて革新的なアイディアを提案し、目標達成に導く。 スタディチームメンバーをメンタリングする。 組織内で求められるワークキンググループ、タスクフォース、SME(Subject Matter Expert)に貢献する。 必要に応じ、規制当局による調査対応をリードする。 様々の業務において、ラインマネジャーをアシストする。 ラインマネジャーより任命されたその他業務を遂行する。 SMP、SOP、GCP、ガイドラインおよび規制要件に従い、被験者の安全性を確保する。 • Identifies new potential Investigators, through ongoing collaborations with internal and external stakeholders. Assesses potential Investigators and their sites to ensure they have the resources and capabilities to conduct clinical trials. Documents the visit, and communicate findings. Provides feedback on Potential Site Assessment findings to collaborators Recommends sites during the site feasibility and/or site selection process.• Develops new sites, who have minimal research experience, by providing support in understanding the requirements to run clinical trials (i.e. SOPs, Training, Staff resources etc.)• Determines the need and/or type of pre-study visit that is required depending on the site’s previous experience with running BMS clinical trials • Conducts initiation visits in collaboration with other study team members and ancillary functional groups. Provides protocol specific and individualized training based on the Investigator and site personnel experience, prior to site activation• Reviews site activities and quality through on-site and off-site visits. Conducts monitoring activities and ensures safety and protection of study subjects as per the monitoring plan, BMS PBPDs and best practices, protocol, ICH/GCP Guidelines and other local regulations as applicable • Perform Unblinded Site Monitor activities to protect the blind of the study by acting as secondary monitoring source separate from the blinded monitor. Includes site monitoring activities for pharmacy, randomization review, drug accountability, and reconciliation of the blinded investigational products. Work with Unblinded study staff including pharmacists or Unblinded drug preparers and communicate only with internal BMS Unblinded study personnel during the study conduct.• While monitoring demonstrates the ability to use data to assess risks, identify issues and make appropriate decisions. Identifies Key factors and the relative significance of a problem. Analyze root cause and potential bias. Seeks for appropriate input and creates a corrective and or / preventive action plan and communicate the process in a logical and timely manner• Performs site closure activities when all required protocol visits and follow-up are completed• Manages multiple protocols, across multiple therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory.• Ensures quality of data submitted from study sites and assures data currency by using the available systems to follow site activities.• Clinical Data Listing review is performed at the assigned timepoints according to the Data Review Plan and/or SMP• Supervises overall activities of site personnel over whom there is no direct authority. We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference. Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Bristol-Myers Squibb 3803, 1664 Sheepshead Bay Rd, Brooklyn, NY 11235, USA
Apr 19, 2018
治験を適切に実施できる医療機関/治験責任医師の情報を収集、選定する。 GCP、ガイドライン、社内/治験実施医療機関のSOPに従い、サイトマネジャーと協働し、治験依頼、手続き書類を作成、治験費用および契約の交渉、契約締結する。 スタディチームメンバーと協働し、治験開始に必要なドキュメント、資料を作成する。 治験実施医療機関(担当医師、治験スタッフ)と協議し、適切に臨床試験が実施される体制を確立する。 治験に関連した必要な資料を提供し、説明する。 業務委託スタッフの各種業務の進捗を把握、管理し、臨床試験実施における治験手続全般をコーディネートする。 担当医師、治験スタッフとコンタクトを取り、タイムラインに沿った評価可能症例を確保し、進捗を管理する。 スタディチームメンバーと治験実施医療機関における情報を共有し、担当医療機関における問題を事前に特定、解決案を提案、実行する。 治験実施医療機関からの問い合わせ、質問に対して自主的に回答し、解決を図る。 治験実施医療機関において適切に治験が実施されているか確認する。必要に応じ、治験スタッフおよび/あるいはスタディチームメンバー(Outsourceモニターを含む)にトレーニングを提供する。 逸脱発生時の再発防止策を検討し、適切に記録(issue report、follow-up letter、モニタリング記録等)を作成する。 治験実施医療機関レベルの潜在的なリスクを特定し、解決策を提案する。 治験データがタイムリーに電子症例報告書に入力されていること、およびそのデータの品質を確保する。 適切かつタイムリーにモニタリング報告書および関連文書を作成、提出する。 モニタリング業務の効率化/標準化を図ることで業務を簡素化するとともに、求められる質を維持するためのツール作成やトレーニングの実施等の方策を講じる。 予算およびリソースの有効活用を最大化し、目標達成に向けて革新的なアイディアを提案し、目標達成に導く。 スタディチームメンバーをメンタリングする。 組織内で求められるワークキンググループ、タスクフォース、SME(Subject Matter Expert)に貢献する。 必要に応じ、規制当局による調査対応をリードする。 様々の業務において、ラインマネジャーをアシストする。 ラインマネジャーより任命されたその他業務を遂行する。 SMP、SOP、GCP、ガイドラインおよび規制要件に従い、被験者の安全性を確保する。 • Identifies new potential Investigators, through ongoing collaborations with internal and external stakeholders. Assesses potential Investigators and their sites to ensure they have the resources and capabilities to conduct clinical trials. Documents the visit, and communicate findings. Provides feedback on Potential Site Assessment findings to collaborators Recommends sites during the site feasibility and/or site selection process.• Develops new sites, who have minimal research experience, by providing support in understanding the requirements to run clinical trials (i.e. SOPs, Training, Staff resources etc.)• Determines the need and/or type of pre-study visit that is required depending on the site’s previous experience with running BMS clinical trials • Conducts initiation visits in collaboration with other study team members and ancillary functional groups. Provides protocol specific and individualized training based on the Investigator and site personnel experience, prior to site activation• Reviews site activities and quality through on-site and off-site visits. Conducts monitoring activities and ensures safety and protection of study subjects as per the monitoring plan, BMS PBPDs and best practices, protocol, ICH/GCP Guidelines and other local regulations as applicable • Perform Unblinded Site Monitor activities to protect the blind of the study by acting as secondary monitoring source separate from the blinded monitor. Includes site monitoring activities for pharmacy, randomization review, drug accountability, and reconciliation of the blinded investigational products. Work with Unblinded study staff including pharmacists or Unblinded drug preparers and communicate only with internal BMS Unblinded study personnel during the study conduct.• While monitoring demonstrates the ability to use data to assess risks, identify issues and make appropriate decisions. Identifies Key factors and the relative significance of a problem. Analyze root cause and potential bias. Seeks for appropriate input and creates a corrective and or / preventive action plan and communicate the process in a logical and timely manner• Performs site closure activities when all required protocol visits and follow-up are completed• Manages multiple protocols, across multiple therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory.• Ensures quality of data submitted from study sites and assures data currency by using the available systems to follow site activities.• Clinical Data Listing review is performed at the assigned timepoints according to the Data Review Plan and/or SMP• Supervises overall activities of site personnel over whom there is no direct authority. We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference. Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Bristol-Myers Squibb 3803, 1664 Sheepshead Bay Rd, Brooklyn, NY 11235, USA