Bristol-Myers Squibb Company

  • Bristol-Myers Squibb Corporate Headquarters 430 E. 29th Street, 14th Floor, New York, NY 10016
  • https://www.bms.com
Bristol-Myers Squibb Company Princeton, NJ, USA
Jul 19, 2019
Full time
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. The Vendor Oversight Lead, Global Clinical Trial Business Partnerships is a role considered essential to the sustainability and success of the BMS R&D pipeline. This role reports to the Associate Director, Global Vendor Oversight & Operations and is a key member of the broader Global Clinical Trial Business Partnerships Team. This is an individual contributor role who has demonstrated core expertise in the business management of vendor oversight, assessment and due diligence. Position Responsibilities Management of vendor oversight requirements and documentation Project management of vendor assessment & due diligence activities for all GCO vendors Providing guidance and support activities within global clinical operations (GCO) to team members for all vendor oversight, assessment and due diligence activities Standardization of vendor oversight requirements and reporting Training of all processes related to vendor oversight, assessment and due diligence for involved staff Completes and/or assists with final due diligence reporting Stakeholder management among cross-functional groups and vendors to ensure team attendance / assistance / expertise Communicates with all levels of organization Drive project timelines to ensure project success Process Improvement to existing methods / Establishing best practices for current SOPs SOP and guidance document updates Management /design of vendor database and SharePoint site Collaborates with Global Procurement regarding sourcing events and awards Reporting, analysis, special Projects Responsibility for supporting ongoing vendor oversight and documentation across Clinical Trial Business Partnerships Experience and Expertise Required Bachelor's degree required with an advanced degree preferred At least 5 years of relevant industry experience, with substantial business experience and experience leading teams 5 years of Project Management experience Track record of leading through influence, working across complex, global organizational matrices Demonstrated influential leadership and communication capabilities with a proven ability to engage, manage, develop and inspire a team Business, operational, stakeholder management experience First-hand experience of working directly with Contract Service Providers (CSPs), investigators, customers, opinion leaders and professional staff as well as broad exposure to business in general Ability to lead others Demonstrated ability to effectively communicate to a diverse audience at multiple levels within the company Demonstrated ability of managing and working with cross-functional / teams in a complex, changing environment to deliver value-added results to the organization Demonstrated ability to define projects, translate it into actionable plans and manage implementation Experience in change management and process improvement High level of adaptability in dealing with complex work environments Balances priorities and multiple demands in a responsive and professional manner Escalates and keeps leadership aware of status, issues Drive efficient and effective meetings Drive communication and training for GCO vendor oversight, assessment and due diligence Support other groups within GCO as necessary
Bristol-Myers Squibb Company Santa Monica, CA, USA
Jul 19, 2019
Full time
Bristol-Myers Squibb is looking for a Senior Territory Business Manager for the Santa Monica territory. 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. And 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. Summary Understands and applies knowledge of health care industry, trends, applicable laws and regulations, market conditions, and the managed health care environment into business plans and in daily execution of sales calls within compliance guidelines. Develops and implements territory plans that properly identify and prioritize activities to accomplish short and long term business plan goals. Demonstrates clear and thorough understanding of disease states, BMS products and relevant competitor products, including their mechanisms of action, indications, efficacy, safety, etc. Collaborates with territory matrix team on identifying opportunities and developing appropriate tactics and strategies. Builds and maintains strong professional relationships with physicians in private practice, medical group practices and or hospitals, office staffs and others in the patient care continuum. Fosters team effectiveness and accomplishment of shared goals by sharing knowledge, experience, and information. Drives market share growth and maximizes sales performance within the indicated use and for the approved patients. Requirements The successful candidate must have a bachelor's degree or equivalent with minimum of 3 years of Pharmaceutical Sales Representative experience. Demonstrated strong sales performance track record. Demonstrated understanding of the business drivers, dynamics, regulations and managed health care within the pharmaceutical industry. Demonstrated skills at building and maintaining professional relationships with key customers, office staff and others in the customer influence network. Effectively use active listening, probing and other selling skills to enhance communication, build and influence key customers. Demonstrated ability to analyze, develop and execute business plans. Demonstrated ability to work in matrix teams. Demonstrated track record of developing self to drive and enhance performance. Infusions & injectable, the Buy and Bill office model and Medicare Part B Reimbursement is a significant plus. 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 Company Princeton, NJ, USA
Jul 19, 2019
Full time
Description of the area: Global Quality (GQ) - Clinical Trials and Safety, GQ-CT&S is responsible for auditing all processes related to clinical research includingspecific medical affairs processes, and pharmacovigilance activities, to assess compliancewith relevant regulations and applicable policies and procedures. This includesinvestigator site, internal systems (e.g. REMS, clinical monitoring), and external clinical trial related vendor audits. Our department is alsoresponsible for management of regulatory agency inspections and for providing advice on regulatory (GCP and GVP) requirements. GQ also offers support as SME during Due Diligence and if areas of serious non-compliance are identified. Purpose/Objective of the job Conduct Good Clinical Practice (GCP) and pharmacovigilance (PV) audits as above described. Act as project-specific liaison between R&D Quality - CT&S and key stakeholders, includingGlobal Clinical Operations and Global Regulatory, Safety & Biometrics (GRSB) personnel,monitoring the status of the project(s) to plan audits and assuring R&D Quality - CT&S leadership as informed. Key Responsibilities and Major Duties Perform GCP and PV audits, including audits of clinical investigator sites, vendors, internalsystems and clinical study reports to assess regulatory compliance; Apply audit principles, procedures, and methods; Collect information through effective interviewing, listening, observing and reviewingdocuments, records and data; Prioritize and focus on matters of significance; Confirm the sufficiency and appropriateness of audit evidence to support audit findingsand conclusions; Assess those factors that may affect the reliability of the audit findings and conclusions; Prepare clearly-written, concise, accurate and evidence-based audit report; Review and assess (or support the review) received corrective and preventive action plans according to specifiedtimelines to ensure resolution of audit findings and prevent recurrence. Maintain an in-depth knowledge of governmental regulations impacting clinical researchand PV and development of medicines. Provide advice and counsel concerning GCP regulatory requirements. Collaborate with management in creating and/or reviewing metrics and trend analyses on audits/inspection findings and related CAPAs, for escalation to management and stakeholder Act as project-specific liaison (Project Coordinator) and provide input into audit plans and strategy. Regularly evaluate clinical research processes to determine compliance withregulatory requirements and established standard operating procedures. May provide mentoring for new staff, as needed. Regular collaboration/contact with GCO and GRSB personnelrelated to projects for which the incumbent is Project Coordinator. Possible interactions with external auditors and Regulatory Agency inspectors during the conduct of healthauthority inspections either at clinical sites or at BMS facilities. Miscellaneous contacts as assigned by R&D quality -CT&S management. Supervisory Responsibility None Key Stakeholders/Contacts - Regular contact and collaboration with Global Quality CT&S strategy roles, GQ and Clinical Quality governance (risk management and CAPA), colleagues/co-auditors located globally; Contact with appropriate technical, supervisory and management personnel internallyand externally (investigator sites, vendors, etc.) in the conduct and reporting of audits. List of minimum requirements Degree/Certification/Licensure Bachelor's degree required - Life Sciences degree preferred Experience/Responsibility and minimum # of years: Solid previous experience in clinical trial related roles Demonstrated specifictechnical knowledge of the GCP areas subject to audit, as evidenced by atIeast 4 years in the pharmaceutical industrypreferably in the R&D/clinical trial or equivalent area. Desired minimum 2 years of auditing (GCP auditing is preferred) Competencies/Knowledge/skills Strong skill in risk based prioritization Strong critical thinking to analyze complexsituations and discern critical issues andnon-compliant situations and torecommend appropriate corrective and preventive actions; Good understanding of the drugdevelopment process Demonstrates computer literacy and is ableto function independently within an environment that relied heavily on technology for information and communication Excellent oral and written communication; Fluent in English (and other languages, asapplicable to assigned audit region); Sense of diplomacy and discretion; Maintains the confidentiality and securityof information, data and records; Demonstrates commitment to deliveringhigh-quality work product; Knowledge of governmental regulations impacting clinical research and drug development Understand the appropriateness andconsequences of using sampling techniques for auditing; Ability to make ethical, scientifically soundrecommendations, consistent with company policy/strategy and cost effective; Demonstrates flexibility, open-mindednessand adaptability to a rapidly changing environment; Develops strong working relationships withkey stakeholders; Ability to manage competing priorities. BMS Behaviors and Working conditions : BMS Biopharma Behaviors required: Passion, Accountability, Innovation,Speed Travel Required (nature and frequency) approximately 25% travel to perform auditsand attend professional meetings andseminars. Overnight Absences Required (pertypical month): Approximately 5 days per month Software that must be usedindependently and without assistance (e.g., Microsoft Suite, Electronic Trial Master File, Oracle clinical database, RAVE, Trackwise, Sharepoint, etc )
Bristol-Myers Squibb Company Cambridge, MA, USA
Jul 19, 2019
Full time
The Research Associate will join the Oncology Resistance Biology group at Bristol-Myers Squibb in Cambridge, MA and aide in the advancement of early stage therapeutic targets at the intersection of tumor genetics and tumor immunobiology. The position will utilize cellular biological and immunological techniques to screen and validate targets that confer resistance to immunotherapies. The qualified candidate is a highly motivated, interactive, and creative individual that possesses the ability to work across a highly matrixed environment to advance preclinical drug development programs from target identification/validation through IND enabling studies. The candidate will be expected to effectively collaborate with colleagues in the oncology, immunology, immuno-oncology, protein engineering/antibody development and medicinal chemistry groups. The successful candidate will demonstrate clear and professional verbal and written communication, capable of presenting scientific results to multidisciplinary teams. Qualifications • A B.S. with a minimum of 2 years of experience, or an M.S. with research experience in cellular biology and/or immunology is required. • Demonstrated experience in experimental design, execution, data analysis and troubleshooting are required. • Hands on experience with a wide range of cellular biology and immunology assays, including cell culture, flow cytometry, western blotting, ELISA, siRNA/shRNA knockdown, CRISPR-mediated genome editing, qPCR, cloning, cell proliferation assays, lentivirus generation and transduction is required. • Experience in utilizing software such as Graph Pad, Flowjo, Microsoft office etc. for data analysis and figure generation is highly desired. • Experience with functional genetic and/or small molecule screens and next generation sequencing library preparation is desired. • Experience with in vivo/ex vivo pharmacology, including rodent handling and common procedures including tissue processing is desired. • Experience in cancer genome data mining through use of desktop tools/interfaces and public databases (e.g., CBIO, TCGA, CCLE, Genepattern etc) is desirable. • Attention to detail with excellent organizational and record keeping skills is a requirement. • Excellent interpersonal skills with the ability to interact effectively with people, internally and externally is required. • This position is located in Cambridge, MA. There will be less than 10% travel. . 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. And 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.
Bristol-Myers Squibb Company Princeton, NJ, USA
Jul 19, 2019
Full time
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. The Vendor Oversight Lead, Global Clinical Trial Business Partnerships is a role considered essential to the sustainability and success of the BMS R&D pipeline. This role reports to the Associate Director, Global Vendor Oversight & Operations and is a key member of the broader Global Clinical Trial Business Partnerships Team. This is an individual contributor role who has demonstrated core expertise in the business management of vendor oversight, assessment and due diligence. Position Responsibilities Management of vendor oversight requirements and documentation Project management of vendor assessment & due diligence activities for all GCO vendors Providing guidance and support activities within global clinical operations (GCO) to team members for all vendor oversight, assessment and due diligence activities Standardization of vendor oversight requirements and reporting Training of all processes related to vendor oversight, assessment and due diligence for involved staff Completes and/or assists with final due diligence reporting Stakeholder management among cross-functional groups and vendors to ensure team attendance / assistance / expertise Communicates with all levels of organization Drive project timelines to ensure project success Process Improvement to existing methods / Establishing best practices for current SOPs SOP and guidance document updates Management /design of vendor database and SharePoint site Collaborates with Global Procurement regarding sourcing events and awards Reporting, analysis, special Projects Responsibility for supporting ongoing vendor oversight and documentation across Clinical Trial Business Partnerships Experience and Expertise Required Bachelor's degree required with an advanced degree preferred At least 5 years of relevant industry experience, with substantial business experience and experience leading teams 5 years of Project Management experience Track record of leading through influence, working across complex, global organizational matrices Demonstrated influential leadership and communication capabilities with a proven ability to engage, manage, develop and inspire a team Business, operational, stakeholder management experience First-hand experience of working directly with Contract Service Providers (CSPs), investigators, customers, opinion leaders and professional staff as well as broad exposure to business in general Ability to lead others Demonstrated ability to effectively communicate to a diverse audience at multiple levels within the company Demonstrated ability of managing and working with cross-functional / teams in a complex, changing environment to deliver value-added results to the organization Demonstrated ability to define projects, translate it into actionable plans and manage implementation Experience in change management and process improvement High level of adaptability in dealing with complex work environments Balances priorities and multiple demands in a responsive and professional manner Escalates and keeps leadership aware of status, issues Drive efficient and effective meetings Drive communication and training for GCO vendor oversight, assessment and due diligence Support other groups within GCO as necessary
Bristol-Myers Squibb Company Princeton, NJ, USA
Jul 19, 2019
Full time
Description of the area: Global Quality (GQ) - Clinical Trials and Safety, GQ-CT&S is responsible for auditing all processes related to clinical research includingspecific medical affairs processes, and pharmacovigilance activities, to assess compliancewith relevant regulations and applicable policies and procedures. This includesinvestigator site, internal systems (e.g. REMS, clinical monitoring), and external clinical trial related vendor audits. Our department is alsoresponsible for management of regulatory agency inspections and for providing advice on regulatory (GCP and GVP) requirements. GQ also offers support as SME during Due Diligence and if areas of serious non-compliance are identified. Purpose/Objective of the job Conduct Good Clinical Practice (GCP) and pharmacovigilance (PV) audits as above described. Act as project-specific liaison between R&D Quality - CT&S and key stakeholders, includingGlobal Clinical Operations and Global Regulatory, Safety & Biometrics (GRSB) personnel,monitoring the status of the project(s) to plan audits and assuring R&D Quality - CT&S leadership as informed. Key Responsibilities and Major Duties Perform GCP and PV audits, including audits of clinical investigator sites, vendors, internalsystems and clinical study reports to assess regulatory compliance; Apply audit principles, procedures, and methods; Collect information through effective interviewing, listening, observing and reviewingdocuments, records and data; Prioritize and focus on matters of significance; Confirm the sufficiency and appropriateness of audit evidence to support audit findingsand conclusions; Assess those factors that may affect the reliability of the audit findings and conclusions; Prepare clearly-written, concise, accurate and evidence-based audit report; Review and assess (or support the review) received corrective and preventive action plans according to specifiedtimelines to ensure resolution of audit findings and prevent recurrence. Maintain an in-depth knowledge of governmental regulations impacting clinical researchand PV and development of medicines. Provide advice and counsel concerning GCP regulatory requirements. Collaborate with management in creating and/or reviewing metrics and trend analyses on audits/inspection findings and related CAPAs, for escalation to management and stakeholder Act as project-specific liaison (Project Coordinator) and provide input into audit plans and strategy. Regularly evaluate clinical research processes to determine compliance withregulatory requirements and established standard operating procedures. May provide mentoring for new staff, as needed. Regular collaboration/contact with GCO and GRSB personnelrelated to projects for which the incumbent is Project Coordinator. Possible interactions with external auditors and Regulatory Agency inspectors during the conduct of healthauthority inspections either at clinical sites or at BMS facilities. Miscellaneous contacts as assigned by R&D quality -CT&S management. Supervisory Responsibility None Key Stakeholders/Contacts - Regular contact and collaboration with Global Quality CT&S strategy roles, GQ and Clinical Quality governance (risk management and CAPA), colleagues/co-auditors located globally; Contact with appropriate technical, supervisory and management personnel internallyand externally (investigator sites, vendors, etc.) in the conduct and reporting of audits. List of minimum requirements Degree/Certification/Licensure Bachelor's degree required - Life Sciences degree preferred Experience/Responsibility and minimum # of years: Solid previous experience in clinical trial related roles Demonstrated specifictechnical knowledge of the GCP areas subject to audit, as evidenced by atIeast 4 years in the pharmaceutical industrypreferably in the R&D/clinical trial or equivalent area. Desired minimum 2 years of auditing (GCP auditing is preferred) Competencies/Knowledge/skills Strong skill in risk based prioritization Strong critical thinking to analyze complexsituations and discern critical issues andnon-compliant situations and torecommend appropriate corrective and preventive actions; Good understanding of the drugdevelopment process Demonstrates computer literacy and is ableto function independently within an environment that relied heavily on technology for information and communication Excellent oral and written communication; Fluent in English (and other languages, asapplicable to assigned audit region); Sense of diplomacy and discretion; Maintains the confidentiality and securityof information, data and records; Demonstrates commitment to deliveringhigh-quality work product; Knowledge of governmental regulations impacting clinical research and drug development Understand the appropriateness andconsequences of using sampling techniques for auditing; Ability to make ethical, scientifically soundrecommendations, consistent with company policy/strategy and cost effective; Demonstrates flexibility, open-mindednessand adaptability to a rapidly changing environment; Develops strong working relationships withkey stakeholders; Ability to manage competing priorities. BMS Behaviors and Working conditions : BMS Biopharma Behaviors required: Passion, Accountability, Innovation,Speed Travel Required (nature and frequency) approximately 25% travel to perform auditsand attend professional meetings andseminars. Overnight Absences Required (pertypical month): Approximately 5 days per month Software that must be usedindependently and without assistance (e.g., Microsoft Suite, Electronic Trial Master File, Oracle clinical database, RAVE, Trackwise, Sharepoint, etc )
Bristol-Myers Squibb Company Santa Monica, CA, USA
Jul 19, 2019
Full time
Bristol-Myers Squibb is looking for a Senior Territory Business Manager for the Santa Monica territory. 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. And 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. Summary Understands and applies knowledge of health care industry, trends, applicable laws and regulations, market conditions, and the managed health care environment into business plans and in daily execution of sales calls within compliance guidelines. Develops and implements territory plans that properly identify and prioritize activities to accomplish short and long term business plan goals. Demonstrates clear and thorough understanding of disease states, BMS products and relevant competitor products, including their mechanisms of action, indications, efficacy, safety, etc. Collaborates with territory matrix team on identifying opportunities and developing appropriate tactics and strategies. Builds and maintains strong professional relationships with physicians in private practice, medical group practices and or hospitals, office staffs and others in the patient care continuum. Fosters team effectiveness and accomplishment of shared goals by sharing knowledge, experience, and information. Drives market share growth and maximizes sales performance within the indicated use and for the approved patients. Requirements The successful candidate must have a bachelor's degree or equivalent with minimum of 3 years of Pharmaceutical Sales Representative experience. Demonstrated strong sales performance track record. Demonstrated understanding of the business drivers, dynamics, regulations and managed health care within the pharmaceutical industry. Demonstrated skills at building and maintaining professional relationships with key customers, office staff and others in the customer influence network. Effectively use active listening, probing and other selling skills to enhance communication, build and influence key customers. Demonstrated ability to analyze, develop and execute business plans. Demonstrated ability to work in matrix teams. Demonstrated track record of developing self to drive and enhance performance. Infusions & injectable, the Buy and Bill office model and Medicare Part B Reimbursement is a significant plus. 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 Company Princeton, NJ, USA
Jul 19, 2019
Full time
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. Description We are seeking a highly motivated Research Associate to be part of the Translational IHC & Histology Group in Translational Pathology. Members of this team work on various projects in concert with Discovery, Translational Research, Biomarker, Pathology and Pharmacodiagnostics for further development of the BMS Oncology and Immunology pipelines, contributing to target discovery, lead selection, safety assessment, clinical biomarker validation, and indication selection for BMS clinical trials. The successful candidate will be responsible for developing and validating monoplex and multiplex IHC assays, in situ hybridization, and image analysis. She/he will work closely with discovery and translational research scientists, clinical biomarker leads, image analysts and pathologists to develop assays, perform tissue cross-reactivity study and disease profiling, and document assay performance in support of their translation to clinical samples. The candidate will also be responsible for the preparation and qualification of reagents,the assaytechnology transfer to CROs and other bioanalytical assays as needed to support Translational Research, as well as contribute to the preparation and presentation of scientific findings. Job Requirements/Education BS required and MS preferred with 3~5 years of relevant experience in life Science discipline. Applicants from academics and industry will be considered. Preference will be given to individuals with previous experience working in the fields of oncology and immunology and working in a GLP or GCLP environment. Proven technical expertise in developing and implementing manual or automated immunohistochemistry and in situ hybridization assays. Experience in image analysis, multiplex immunohistochemistry, and laser capture microdissection are highly desirable. Must be organized and able to work well in a team setting. Excellent communication skills, both written and verbal are required.
Bristol-Myers Squibb Company Princeton, NJ, USA
Jul 19, 2019
Full time
Summary As a member of the Bioanalytical Sciences team, the primary purpose of this position is to provide bioanalytical assay support for the development, validation and implementation of fit-for-purpose bioanalytical assays for analysis of preclincal and clinical study samples to assess pharmacokinetics, immunogenicity, and biomarkers for BMS drug discovery and development in a manner consistent with the Core BMS Behaviors. Additionally, the successful candidate will be responsible for: Maintaining state-of-the-art knowledge pertaining to biomarkers and biotherapeutics biology/methodologies/technologies and drug development processes Maintaining awareness of relevant US and foreign regulations and industry best practices Applying innovative bioanalytical ideas and technologies in assay development, automation and laboratory processes Solving technical and experimental problems as well as other unforeseen issues related to both immediate and long-term project goals Representing the department in cross-functional teams and developing strong working relationships with stakeholders Providing scientific and technical oversight on bioanalytical activities outsourced to contract research laboratories Contributing to publications as first or corresponding author, keeping up with literature and training, applying ideas so obtained to work, presenting work at internal and external meetings. Requirements PhD in relevant scientific discipline (immunology, biology, biochemistry, etc.) with 4 or more years of relevant experience, or MS in relevant scientific discipline with 7 or more years of relevant experience. The candidate should have proven experience in leading developing de-novo immunochemistry based assays in technologies such as ELISA, ECL, Gyros, and Luminex in support of biotherapeutics and biomarker projects. Excellent understanding of regulatory guidances and industry white papers relevant to bioanalytical and biomarker assays is required. Knowledge and experience in translational biomarker research, proteomics, in vitro diagnostics, cell-based assays, and tissue analysis are highly desirable. Work experience in a pharmaceutical or biotech company is preferred. Experience in managing biomarker assays in contract research laboratories is a plus Excellent written and verbal communication skills are required
Bristol-Myers Squibb Company Downtown, Los Angeles, CA, USA
Jul 19, 2019
Full time
Summary The FMS role embodies our medical mission in becoming a trusted, agile partner who engages in relevant dialogue and delivers timely, high impact data and insights that advance the science or accelerate access, optimize medical practice and drive appropriate adoption of BMS medicines. The FMS role is field-based and it is anticipated that an FMS will spend a minimum of 60-70% of their time in the field with external customers. The primary role of the FMS is to develop relationships and maintain contacts with research focused Thought Leaders (TL) and Healthcare Providers (HCP) within their healthcare system. The purpose of interactions is to engage in meaningful scientific exchange that will ensure patients have access to BMS medicines, to ensure their safe and appropriate use through peer to peer discussions aligned with medical strategies and needs expressed by external stakeholders. The scientific dialogue focuses on scientific/clinical information around disease management, treatment landscape, and BMS products in a fair and balanced way and includes appropriate clinical and value related discussions. External Environment and Customer Focus Develop and maintain relationships with academic and community research thought leaders, appropriate HCPs,and access stakeholders, within a given geography to answer scientific, unsolicited product and HEOR related questions. The FMS will use various channels for interactions (1:1, group presentation; remote, etc). Demonstrate proficiency in using available scientific resources and presentations. Effectively present information to TL/HCPs and be able to respond to questions, ensuring medical accuracy and compliance with local procedures, ethical and legal guidelines and directives. Actively assess the medical landscape by meeting with TL/HCPs to understand their needs and expertise. Continuously update own knowledge in treatment strategies, products, unmet medical needs, clinical trials and scientific activities. Understand the competitive landscape and actively prepare to address informational needs of customers. Collect and provide meaningful medical insights and/or impact by communicating these back to the medical and commercial organizations to be actioned in support of the strategy development. Contribute to the Medical Plan Adopt institution/account planning approach and contribute to cross-functional institution/account plans. Contribute to development and delivery of scientifically meaningful medical programs/projects in line with the local Medical and Field Medical plan. Provide Medical Support As necessary and appropriate, support the initial and ongoing medical/scientific area and product specific training and provide key scientific updates to internal stakeholders (e.g. Commercial, Regulatory, Pharmacovigilance, Legal, HEOR, Value Access & Payment). Support Clinical Trial Activities Support Interventional and Non Interventional Research (NIR) studies (e.g. identification and assessment of potential study sites) to support patient recruitment and/or discussions around the safe and effective use of BMS investigational products, as agreed with home office medical and Global Clinical Operations (GCO) and as defined by the study scope document. Provide recommendations and insights to clinical development team on study and site feasibilities within the therapeutic area based on knowledge of the field and through direct contacts with potential investigators, as agreed with home office medical and GCO. Actively support CRO sponsored studies as agreed with home office medical and GCO and as defined by the study scope document. Support HCPs in the ISR submission and execution process and study follow-up as agreed upon with home office medical and GCO. Ensure that BMS Pharmacovigilance procedural documents are understood and applied by investigators of local studies, and alert appropriate BMS personnel to any identified Adverse Events. Required Experience MD, PharmD, DNP, or PhD, with experience in a specific Disease Area or with a broad medical background(preferred) OR Science Graduate with relevant pharmaceutical experience A minimum of 2 years working in a clinical or pharmaceutical environment Knowledge Desired Disease area knowledge and an understanding of scientific publications Knowledge of a scientific or clinical area Knowledge of clinical trial design and process Knowledge of the national healthcare and access environment Knowledge of HEOR core concepts Excellent English language skills, spoken and written Travel required Experience Desired Ability to work independently and act as a team player Translating scientific or clinical data into an understandable and valuable form to help physicians best serve their patients Good communication and presentation skills to present scientific and/or clinical data to research or healthcare professionals Developing peer-to-peer relationships with TLs, scientists and other healthcare professionals Ability to quickly and comprehensively learn about new subject areas and environments Demonstration of the BMS Core Behaviors Essential Qualification Ability to drive a company-provided car is an essential qualification of this position. Candidates must be able to drive a BMS-provided vehicle between locations (often great distances apart), and arrive at each location ready and able to enthusiastically and efficiently demonstrate an applied knowledge of pertinent health care industry trends. Overnight stays as needed. Candidates must possess a high level of ethics, integrity and responsible and safe driving history.
Bristol-Myers Squibb Company Princeton, NJ, USA
Jul 18, 2019
Full time
Summary The primary responsibility for the Medical Communications Manager is supporting the Publications and Scientific Content Leads in the development and delivery of a comprehensive, globally aligned strategic publications and scientific communications plan that reflects priorities for key markets. Roles and Responsibilities Supports a high performing, cross-functional global communications matrix team engaged in the planning, integration and execution of medical publication and scientific content activities globally. Supports Pubs and Scientific Content Leads in translating medical strategies and objectives into actionable long-term strategic communications plans; plans that are comprehensive and globally aligned (representing all functions and key markets with ongoing data generation) Champions the global standardization of immunoscience medical content to streamline creation, distribution and curation of content while eliminating redundancies in resource utilization and number of deliverables. Supports the development of all relevant medical content per clinical development program, publications, data presentations, congress activity, market needs, customer inquiry trends, global communication platform, product safety reports and treatment landscape. Manages the development and maintenance of Standard Response Documents to ensure concise, comprehensive responses to the most frequently posed questions, to facilitate a rapid response to customer enquiries around the world. Liaising with market-level content leads and HQ medical to determine the need for new documents, and where old documents can be retired. Plays an active role in the Medical Capabilities Integration Team (MCIT) Meetings to solicit and understand Market-level insights, publications and scientific content needs and reflect it accordingly in deliverables to ensure relevance and applicability to local market; also to ensure that local markets are familiar with global publications and scientific content strategies and plans. Budget Management - Working closely with the Medical Communications Execution Lead (MCEL) and Pubs/Scientific Content Leads, responsible for budget development, management and tracking, SOW review, invoice approvals, and SO management of assigned therapeutic areas. Works to build and demonstrate understanding of the disease area, medical strategies and objectives necessary to provide strategic input to a broad range of stakeholders on matters related to publication and scientific content planning & data dissemination/disclosure under the direct mentorship of the Global Publications and Scientific Content Leads. Reviews publication drafts for scientific quality and to ensure alignment & consistency with author direction, the scientific communication platform and key communication points supported by data. Manages Medical Writers and Medical Communications agencies in the authoring of content while ensuring alignment with AMA style, BMS standards and BMS content templates & style. Provides medical expertise and support to help address complex customer inquiries on the Immunoscience portfolio. Supports the development of Medical Contact Center training on disease state, product overview and relevant market events to ensure Contact Center's readiness to address customer inquiries. Ensures all publications and scientific content is data validated and supported by appropriate reputable references. Engages and effectively aligns across a broad range key internal stakeholders (Global Biostatistical Sciences, Global & Regional Medical teams and Health Economics & Outcomes Research) to facilitate decision making during publication planning and execution process. Employs innovative strategies and solutions to ensure timely communication of scientific data. Engages and partners with key internal stakeholders (Medical Information, Contact Centers, HEOR and Access, Public Affairs, Medical Capabilities, MDO) to facilitate early identification anticipated data disclosures that may be relevant for key external audiences enabling timely preparation of other data-dependent communications. Communicates timely publication and scientific content updates and metrics to key stakeholders to facilitate ongoing functional and regional planning and inform dependencies. Promotes and reinforces (supports) good publication practices and principles among authors and internal publication stakeholder community ensuring all publications are being authored, written, and reviewed according to GPP3 and BMS processes. Position Requirements Advanced degree preferred: PharmD, PhD or MD in a science subject or biomedical degree preferred; bachelor's degree in biomedical discipline or equivalent with in depth experience in publication management considered A minimum of 1-5 years' experience within the pharmaceutical or related healthcare industry, ideally in both a regional and global capacity Working knowledge of scientific publication strategy, planning and execution during all phases of drug development and commercialization process (investigational, registrational, pre & post-launch and marketed) Scientific expertise in the disease/therapeutic area (rheumatology/Immunoscience) preferred Experience working in highly matrix environment across a broad range of functional areas and effectively collaborating with the Medical Affairs, Health Outcomes, R&D, regulatory, legal and commercial teams Understanding of the clinical trial design and execution, statistical methods and clinical trial data reporting requirements Understanding of good publication practices and guidance (GPP3, ICMJE), Sunshine Act, Pharma Code of Conduct, and other guidance related to post-marketing practices and scientific data communication Outstanding interpersonal, written and verbal communication skills with exceptional time management skills are required for this highly visible global position Working knowledge of Microsoft Suite applications. Familiarity with publication management tools & systems (Datavision) desirable (but can be learned on the job) Willingness and ability to travel for congresses, publication steering committees etc.
Bristol-Myers Squibb Company Cambridge, MA, USA
Jul 18, 2019
Full time
Senior Research Investigator (Single cell Genomics- BMS-Cambridge) R 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. We seek a highly motivated, detail-oriented leader with broad experience in application of single cell genomics tools in solving complex biological problems. Experience implementing or optimizing methods for single cell RNA-seq, single cell DNA -seq or CITE-seq approaches preferred. The successful candidate will have broad experience in Next Generation Sequencing (NGS) work flows and associated analysis methods. Proficiency in various genomics methods and workflows is essential. The individual will be part of the Genomics group at our Cambridge site, working as part of an integrated team dedicated to understanding mechanisms of immune resistance in cancer. Primary responsibilities include various single cell genomics-based assay development and implementation in support of drug discovery programs, novel genomic method development and optimization, establishing outreach and collaboration across the Cambridge area, leveraging its vibrant genomics ecosystem. Responsibilities: Play a key role in the method development for high throughput single cell RNA and DNA and CITE-Seq approaches. Provide genomics assay support for various programs. Play a role in optimizing and developing new and existing NGS protocols to suit needs. Manage Research scientists to deliver data to investigators Genomics data interpretation and presentation to key stake holders Maintain lab notebooks, compile data, and detail written experimental instructions, particularly in areas involving new technology and/or novel experimental approaches. Requirements: The successful candidate will have Ph.D. in Molecular/Cell Biology or Genetics or Biochemistry with at least 5 years or M.S in Molecular/Cell Biology or Genetics with at least 8 years of relevant scientific lab experience with emphasis on Next Generation Sequencing (NGS) work flow and other genomics methods. Robust experience in NGS work flow including library generation and relevant method development. Broad experience in advanced Cell and Molecular Biology technique is essential. Experience in various single cell genomics is required. Experience in working with FFPE and other clinical sample handling preferred. Detail oriented and effective communicator. Expertise in cell separation technologies such as FACS/Microfluidics a plus but not essential. Strong focus, motivation, and commitment to hands-on lab work. Ability to trouble shoot and make independent decisions regarding experimental details Extensive people and project/matrix team experience, with demonstrated ability to work effectively within multidisciplinary teams. Flexibility to accommodate to rapidly changing priorities and deadlines
Bristol-Myers Squibb Company Princeton, NJ, USA
Jul 18, 2019
Full time
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. Job Description: Developing bioanalytical strategies for various biologics programs following internal SOPs and Health Authority guidance. Acting as the bioanalytical liaison with clinical, and non-clinical internal cross-functional project teams and external collaborators Assisting in preparation of regulatory documents including INDs, NDAs, and BLA submission documents and being responsible for responding to Health Authority queries related to bioanalysis Developing or overseeing development and validation of high quality ligand binding assays in support of PK/PD/Immunogenicity assessments. Managing technology transfers of immunogenicity and PK methods and related bioanalytical activities (e.g., development data, validation and study reports) to contract research laboratories and ensuring the scientific quality of data in order to meet health authority regulatory expectations. Performing as needed technical audits of existing contract research laboratories supporting bioanalytical work Contributing to the preparation of technical reports and departmental SOPs and the preparation and presentation of scientific material at internal and external meetings. The successful candidate will be encouraged to publish as part of project publication plans. Ensuring compliance with training requirements at BMS and departmental SOPs, safety guidelines and other applicable regulations. Achieving objectives in a manner consistent with the BMS Biopharma Behaviors. The successful candidate will be self-motivated with good interpersonal and communication skills, and be able to multi-task while meeting objectives in a matrix environment. Requirements: PhD in relevant scientific discipline (biology, biochemistry, chemistry, cell biology etc.) with 2-6 years of relevant experience, or MS in relevant scientific discipline with 5-10 years of relevant experience. The candidate should have proven technical expertise in developing and validating ligand binding assays in technologies such as ELISA, ECL (MSD) or Gyrolab. Experience with cell-based assays relevant to the characterization of anti-drug antibodies, sample management systems and Watson LIMS is a plus. Experience in biological sample handling from clinical or animal studies in a regulated environment is required. Knowledge of GLPs, 21 CFR Part 11, FDA and other relevant Bioanalytical Guidances Good oral and written communication skills are required.
Bristol-Myers Squibb Company Princeton, NJ, USA
Jul 18, 2019
Full time
Responsibilities: Conduct non-interventional research projects using retrospective data resources in support of CORDS customer needs Communicate project status and results effectively to all stakeholders Engage with customer teams on protocol development, statistical analysis, interpretation and presentation of results and strategic direction of messaging and research needs. Provide scientific leadership and guidance related to health and economic outcomes research using non-interventional methods With guidance from team Lead, assist staff with execution of research projects across customer teams Mentor staff in development of functional and behavioral skills related to job performance. Engage key CORDS customers in research and market access needs assessment in order to plan and execute value-focused research projects Assess information environment and analytical tool set to ensure current needs are met and future needs are communicated for assessment by CORDS Data Development team Complete other duties as assigned by CORDS Lead Requirements Masters in biostatistics, epidemiology or related quantitative research field; PhD preferred 5-7 years experience in pharmaceutical outcomes research, pharmaco-epidemiology, health services research or related field 4+ years experience using large retrospective data sets in the conduct of epidemiologic and economic research 4+ years experience with statistical programming using SAS Experience with protocol development and execution for health and economic outcomes research projects Proven strong writing and oral presentation skills 3+ years project leadership experience preferred An ideal candidate will have some experience with the following tools and data analysis methods: Software: SAS, SQL, R, Java, Matlab, C++, Python Data analysis methods: predictive modeling, decision tree analysis, clustering, data mining, data processing, genetic algorithms, machine learning, active machine learning (optimal experimental design), Bayesian optimization
Bristol-Myers Squibb Company Redwood City, CA, USA
Jul 18, 2019
Full time
Associate Research Scientist II , Protein Engineering - D4 Hiring Manager: Andy Deng, Feng Wang, Peter Lee, Conjugations Job Description: We are seeking a skilled and enthusiastic protein engineer at a Research Associate level to join the Protein Engineering Group. The candidate will be expected to work on a variety of protein engineering projects to optimize and generate differentiated antibody therapeutic leads. Specific Responsibilities: • Participate in protein engineering efforts to optimize variable and constant domains of antibodies. • Protein expression of various antigens and antibodies in multiple expression systems (mammalian, insect, yeast, and E. coli) • Protein purification utilizing variety of methods (affinity, ion-exchange, hydrophobic, size-exclusion chromatography) • Perform complex experiments with strong attention to detail and documentation. • Excellent written and oral skills are necessary. • Accomplish goals under project team time lines. Requirements: • BS degree with 5+ years of industry experience or MS degree with 2+ years of industry experience. The degree should be in Biochemistry, Biophysics, Molecular and Cell Biology, Structural biology, or similar field. • Experience in generation and characterization of protein and antibody variants. • Extensive experience and knowledge in molecular biology, protein expression, purification, and characterization. • Excellent time management and organizational skills. • Experience with display technologies a plus • Ability to work in a multidisciplinary biologics discovery team.
Bristol-Myers Squibb Company Princeton, NJ, USA
Jul 18, 2019
Full time
Summary The primary responsibility for the Medical Communications Manager is supporting the Publications and Scientific Content Leads in the development and delivery of a comprehensive, globally aligned strategic publications and scientific communications plan that reflects priorities for key markets. Roles and Responsibilities Supports a high performing, cross-functional global communications matrix team engaged in the planning, integration and execution of medical publication and scientific content activities globally. Supports Pubs and Scientific Content Leads in translating medical strategies and objectives into actionable long-term strategic communications plans; plans that are comprehensive and globally aligned (representing all functions and key markets with ongoing data generation) Champions the global standardization of immunoscience medical content to streamline creation, distribution and curation of content while eliminating redundancies in resource utilization and number of deliverables. Supports the development of all relevant medical content per clinical development program, publications, data presentations, congress activity, market needs, customer inquiry trends, global communication platform, product safety reports and treatment landscape. Manages the development and maintenance of Standard Response Documents to ensure concise, comprehensive responses to the most frequently posed questions, to facilitate a rapid response to customer enquiries around the world. Liaising with market-level content leads and HQ medical to determine the need for new documents, and where old documents can be retired. Plays an active role in the Medical Capabilities Integration Team (MCIT) Meetings to solicit and understand Market-level insights, publications and scientific content needs and reflect it accordingly in deliverables to ensure relevance and applicability to local market; also to ensure that local markets are familiar with global publications and scientific content strategies and plans. Budget Management - Working closely with the Medical Communications Execution Lead (MCEL) and Pubs/Scientific Content Leads, responsible for budget development, management and tracking, SOW review, invoice approvals, and SO management of assigned therapeutic areas. Works to build and demonstrate understanding of the disease area, medical strategies and objectives necessary to provide strategic input to a broad range of stakeholders on matters related to publication and scientific content planning & data dissemination/disclosure under the direct mentorship of the Global Publications and Scientific Content Leads. Reviews publication drafts for scientific quality and to ensure alignment & consistency with author direction, the scientific communication platform and key communication points supported by data. Manages Medical Writers and Medical Communications agencies in the authoring of content while ensuring alignment with AMA style, BMS standards and BMS content templates & style. Provides medical expertise and support to help address complex customer inquiries on the Immunoscience portfolio. Supports the development of Medical Contact Center training on disease state, product overview and relevant market events to ensure Contact Center's readiness to address customer inquiries. Ensures all publications and scientific content is data validated and supported by appropriate reputable references. Engages and effectively aligns across a broad range key internal stakeholders (Global Biostatistical Sciences, Global & Regional Medical teams and Health Economics & Outcomes Research) to facilitate decision making during publication planning and execution process. Employs innovative strategies and solutions to ensure timely communication of scientific data. Engages and partners with key internal stakeholders (Medical Information, Contact Centers, HEOR and Access, Public Affairs, Medical Capabilities, MDO) to facilitate early identification anticipated data disclosures that may be relevant for key external audiences enabling timely preparation of other data-dependent communications. Communicates timely publication and scientific content updates and metrics to key stakeholders to facilitate ongoing functional and regional planning and inform dependencies. Promotes and reinforces (supports) good publication practices and principles among authors and internal publication stakeholder community ensuring all publications are being authored, written, and reviewed according to GPP3 and BMS processes. Position Requirements Advanced degree preferred: PharmD, PhD or MD in a science subject or biomedical degree preferred; bachelor's degree in biomedical discipline or equivalent with in depth experience in publication management considered A minimum of 1-5 years' experience within the pharmaceutical or related healthcare industry, ideally in both a regional and global capacity Working knowledge of scientific publication strategy, planning and execution during all phases of drug development and commercialization process (investigational, registrational, pre & post-launch and marketed) Scientific expertise in the disease/therapeutic area (rheumatology/Immunoscience) preferred Experience working in highly matrix environment across a broad range of functional areas and effectively collaborating with the Medical Affairs, Health Outcomes, R&D, regulatory, legal and commercial teams Understanding of the clinical trial design and execution, statistical methods and clinical trial data reporting requirements Understanding of good publication practices and guidance (GPP3, ICMJE), Sunshine Act, Pharma Code of Conduct, and other guidance related to post-marketing practices and scientific data communication Outstanding interpersonal, written and verbal communication skills with exceptional time management skills are required for this highly visible global position Working knowledge of Microsoft Suite applications. Familiarity with publication management tools & systems (Datavision) desirable (but can be learned on the job) Willingness and ability to travel for congresses, publication steering committees etc.
Bristol-Myers Squibb Company Downtown, Los Angeles, CA, USA
Jul 18, 2019
Full time
Summary The FMS role embodies our medical mission in becoming a trusted, agile partner who engages in relevant dialogue and delivers timely, high impact data and insights that advance the science or accelerate access, optimize medical practice and drive appropriate adoption of BMS medicines. The FMS role is field-based and it is anticipated that an FMS will spend a minimum of 60-70% of their time in the field with external customers. The primary role of the FMS is to develop relationships and maintain contacts with research focused Thought Leaders (TL) and Healthcare Providers (HCP) within their healthcare system. The purpose of interactions is to engage in meaningful scientific exchange that will ensure patients have access to BMS medicines, to ensure their safe and appropriate use through peer to peer discussions aligned with medical strategies and needs expressed by external stakeholders. The scientific dialogue focuses on scientific/clinical information around disease management, treatment landscape, and BMS products in a fair and balanced way and includes appropriate clinical and value related discussions. External Environment and Customer Focus Develop and maintain relationships with academic and community research thought leaders, appropriate HCPs,and access stakeholders, within a given geography to answer scientific, unsolicited product and HEOR related questions. The FMS will use various channels for interactions (1:1, group presentation; remote, etc). Demonstrate proficiency in using available scientific resources and presentations. Effectively present information to TL/HCPs and be able to respond to questions, ensuring medical accuracy and compliance with local procedures, ethical and legal guidelines and directives. Actively assess the medical landscape by meeting with TL/HCPs to understand their needs and expertise. Continuously update own knowledge in treatment strategies, products, unmet medical needs, clinical trials and scientific activities. Understand the competitive landscape and actively prepare to address informational needs of customers. Collect and provide meaningful medical insights and/or impact by communicating these back to the medical and commercial organizations to be actioned in support of the strategy development. Contribute to the Medical Plan Adopt institution/account planning approach and contribute to cross-functional institution/account plans. Contribute to development and delivery of scientifically meaningful medical programs/projects in line with the local Medical and Field Medical plan. Provide Medical Support As necessary and appropriate, support the initial and ongoing medical/scientific area and product specific training and provide key scientific updates to internal stakeholders (e.g. Commercial, Regulatory, Pharmacovigilance, Legal, HEOR, Value Access & Payment). Support Clinical Trial Activities Support Interventional and Non Interventional Research (NIR) studies (e.g. identification and assessment of potential study sites) to support patient recruitment and/or discussions around the safe and effective use of BMS investigational products, as agreed with home office medical and Global Clinical Operations (GCO) and as defined by the study scope document. Provide recommendations and insights to clinical development team on study and site feasibilities within the therapeutic area based on knowledge of the field and through direct contacts with potential investigators, as agreed with home office medical and GCO. Actively support CRO sponsored studies as agreed with home office medical and GCO and as defined by the study scope document. Support HCPs in the ISR submission and execution process and study follow-up as agreed upon with home office medical and GCO. Ensure that BMS Pharmacovigilance procedural documents are understood and applied by investigators of local studies, and alert appropriate BMS personnel to any identified Adverse Events. Required Experience MD, PharmD, DNP, or PhD, with experience in a specific Disease Area or with a broad medical background(preferred) OR Science Graduate with relevant pharmaceutical experience A minimum of 2 years working in a clinical or pharmaceutical environment Knowledge Desired Disease area knowledge and an understanding of scientific publications Knowledge of a scientific or clinical area Knowledge of clinical trial design and process Knowledge of the national healthcare and access environment Knowledge of HEOR core concepts Excellent English language skills, spoken and written Travel required Experience Desired Ability to work independently and act as a team player Translating scientific or clinical data into an understandable and valuable form to help physicians best serve their patients Good communication and presentation skills to present scientific and/or clinical data to research or healthcare professionals Developing peer-to-peer relationships with TLs, scientists and other healthcare professionals Ability to quickly and comprehensively learn about new subject areas and environments Demonstration of the BMS Core Behaviors Essential Qualification Ability to drive a company-provided car is an essential qualification of this position. Candidates must be able to drive a BMS-provided vehicle between locations (often great distances apart), and arrive at each location ready and able to enthusiastically and efficiently demonstrate an applied knowledge of pertinent health care industry trends. Overnight stays as needed. Candidates must possess a high level of ethics, integrity and responsible and safe driving history.
Bristol-Myers Squibb Company Houston, TX, USA
Jul 18, 2019
Full time
Do you have strong leadership skills, the ability to compliantly execute, and have a positive, can-do winning attitude? If you answered yes, and you bring a passion for helping patients and a desire to excel, we want to talk with you. We are currently looking for a specialty biologic Immunoscience Account Manager in the Gulf Coastarea who will have responsibility for selling Nulojix and Orencia IV, for appropriate patients. Your focus will include the transplant team at key transplant centers as well as community-based rheumatologists. Even more specifically, you will excel in: Understanding and applying knowledge of health care industry trends, applicable laws and regulations, market conditions, and the managed health care environment. Developing and implementing territory plans that properly identify and prioritize activities to accomplish business plan goals. Demonstrating clear and thorough understanding of disease states, BMS products and relevant competitor products, including mechanisms of action, indications, safety, and efficacy. Collaborating with extended matrix team on identifying opportunities and developing appropriate strategies and tactics. Building and maintaining strong professional relationships with physicians in hospitals, private practice, medical group practices, office staffs and others in the patient care continuum. Fostering team effectiveness and accomplishment of shared goals by sharing knowledge, experience, and information. Driving market share growth and maximizing sales performance within the indicated use and for the approved patients. The successful candidate must possess each of the following: Bachelors degree or equivalent with minimum of 5 years pharmaceutical sales/medical experience. Infusion/injectable, buy and bill, and Medicare Part B reimbursement experience. Hospital/Institutional experience with specialty pharmaceutical or biotech products. Proven track record in sales, sales/territory planning & tactical execution. Ability to understand and communicate complex disease and product concepts, possess a deep understanding of hospital/institution-based customer needs, and clearly articulate messages to address those needs. Strong written and oral communications, account analysis and planning, teamwork/team effectiveness, working in a matrix team environment, and communicating shared objectives. A high degree of passion, speed, and accountability while working in a rapidly changing environment. Demonstrated skills at building and maintaining professional relationships with key customers, office staff and others in the customer influence network. Demonstrated ability to analyze, develop and execute business plans. Extensive travel is required in some territories. 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 Company Chicago, IL, USA
Jul 18, 2019
Full time
Summary The FMS role embodies our medical mission in becoming a trusted, agile partner who engages in relevant dialogue and delivers timely, high impact data and insights that advance the science or accelerate access, optimize medical practice and drive appropriate adoption of BMS medicines. The FMS role is field-based and it is anticipated that an FMS will spend a minimum of 60-70% of their time in the field with external customers. The primary role of the FMS is to develop relationships and maintain contacts with research focused Thought Leaders (TL) and Healthcare Providers (HCP) within their healthcare system. The purpose of interactions is to engage in meaningful scientific exchange that will ensure patients have access to BMS medicines, to ensure their safe and appropriate use through peer to peer discussions aligned with medical strategies and needs expressed by external stakeholders. The scientific dialogue focuses on scientific/clinical information around disease management, treatment landscape, and BMS products in a fair and balanced way and includes appropriate clinical and value related discussions. External Environment and Customer Focus Develop and maintain relationships with academic and community research thought leaders, appropriate HCPs, and access stakeholders, within a given geography to answer scientific, unsolicited product and HEOR related questions. The FMS will use various channels for interactions (1:1, group presentation; remote, etc). Demonstrate proficiency in using available scientific resources and presentations. Effectively present information to TL/HCPs and be able to respond to questions, ensuring medical accuracy and compliance with local procedures, ethical and legal guidelines and directives. Actively assess the medical landscape by meeting with TL/HCPs to understand their needs and expertise. Continuously update own knowledge in treatment strategies, products, unmet medical needs, clinical trials and scientific activities. Understand the competitive landscape and actively prepare to address informational needs of customers. Collect and provide meaningful medical insights and/or impact by communicating these back to the medical and commercial organizations to be actioned in support of the strategy development. Contribute to the Medical Plan Adopt institution/account planning approach and contribute to cross-functional institution/account plans. Contribute to development and delivery of scientifically meaningful medical programs/projects in line with the local Medical and Field Medical plan. Provide Medical Support As necessary and appropriate, support the initial and ongoing medical/scientific area and product specific training and provide key scientific updates to internal stakeholders (e.g. Commercial, Regulatory, Pharmacovigilance, Legal, HEOR, Value Access & Payment). Support Clinical Trial Activities Support Interventional and Non Interventional Research (NIR) studies (e.g. identification and assessment of potential study sites) to support patient recruitment and/or discussions around the safe and effective use of BMS investigational products, as agreed with home office medical and Global Clinical Operations (GCO) and as defined by the study scope document. Provide recommendations and insights to clinical development team on study and site feasibilities within the therapeutic area based on knowledge of the field and through direct contacts with potential investigators, as agreed with home office medical and GCO. Actively support CRO sponsored studies as agreed with home office medical and GCO and as defined by the study scope document. Support HCPs in the ISR submission and execution process and study follow-up as agreed upon with home office medical and GCO. Ensure that BMS Pharmacovigilance procedural documents are understood and applied by investigators of local studies, and alert appropriate BMS personnel to any identified Adverse Events. Required Experience MD, PharmD, DNP, or PhD, with experience in a specific Disease Area or with a broad medical background (preferred) OR Science Graduate with relevant pharmaceutical experience A minimum of 2 years working in a clinical or pharmaceutical environment Knowledge Desired Disease area knowledge and an understanding of scientific publications Knowledge of a scientific or clinical area Knowledge of clinical trial design and process Knowledge of the national healthcare and access environment Knowledge of HEOR core concepts Excellent English language skills, spoken and written Travel required Experience Desired Ability to work independently and act as a team player Translating scientific or clinical data into an understandable and valuable form to help physicians best serve their patients Good communication and presentation skills to present scientific and/or clinical data to research or healthcare professionals Developing peer-to-peer relationships with TLs, scientists and other healthcare professionals Ability to quickly and comprehensively learn about new subject areas and environments Demonstration of the BMS Core Behaviors Essential Qualification Ability to drive a company-provided car is an essential qualification of this position. Candidates must be able to drive a BMS-provided vehicle between locations (often great distances apart), and arrive at each location ready and able to enthusiastically and efficiently demonstrate an applied knowledge of pertinent health care industry trends. Candidates must possess a high level of ethics, integrity and responsible and safe driving history.
Bristol-Myers Squibb Company Princeton, NJ, USA
Jul 18, 2019
Full time
Summary The Documentation Lead for Full Development and International Submissions is responsible for providing strategic direction and effectively driving the development and implementation of regulatory documentation strategy to deliver key R&D business objectives, support "speed to patient", and facilitate submissions and approvals in key defined markets within global commercial geographic footprint. Aligning with governance on prioritization and execution of documentation submission strategy. Position Requirements PhD/MD/PharmD in a relevant scientific discipline or MS / BS with a minimum of 10 years in pharmaceutical regulatory documentation, or equivalent, and thorough understanding of requirements for high-level summary documents (Module 2 of CTD) Demonstrated leadership in developing and driving the regulatory documentation strategy and managing the regulatory clinical documentation supporting global submissions (BLA/NDA/MAA/Supplements) as well as associated post-submission activities Ability to drive the document development and management of multiple concurrent regulatory submissions (BLA/NDA/MAA/Supplements) and associated post‑submission activities Strong writing skills supporting pharmaceutical regulatory documentation and/or publications in peer-reviewed journals Good understanding of global pharmaceutical drug development and requirements for submission of regulatory dossiers to global health authorities Ability to analyze and interpret complex data from a broad range of scientific disciplines Strong project management and promotes quality of work using strong organizational, communication, facilitation, and interpersonal skills in a cross-functional team Ability to coach and mentor medical writers Working knowledge of a document management system and basic knowledge of document publishing process Position Description Leader of Submission-facing Documentation Strategy Drive the development and manage the implementation of regulatory documentation strategy that support speed and quality performance goals for filing regulatory dossiers as planned by Development Teams Align with Clinical, Statistics, and Regulatory leadership on overall messages and deliverables Lead document prototyping and preparation of processes to ensure: (i) coordination and efficient use of messages between internal development plans and externally submitted documentation (IND/CTA; marketing applications), and (ii) appropriate prioritization of critical versus non-critical path activities Lead the Global Scientific and Regulatory Documentation (GSRD) documentation team on planned submissions Ensure documentation strategy is integrated to support filings, approvals, and/or other regulatory commitments in the intended key markets Accountability for Planning and Preparation of Regulatory Documentation Ensure all asset-facing clinical documentation within GSRD scope of deliverables is identified, resourced, and managed in time-appropriate manner Coordinate documentation activities of multi-functional authors and reviewers from discovery, pharmaceutical development, clinical, and medical; manage the document review process to maximize speed and quality Apply knowledge of internal and external guidance in providing feedback to Development Teams on issues related to regulatory documentation Critically review project-specific model documents, key data texts and displays during dossier prototype creation, and facilitate reaching a consensus at key findings/final document review meeting Influence the assigned Development Team(s) in tracking milestone activities and proactively identify opportunities and threats in terms of submission/documentation activities, and drives potential solutions with key team members In conjunction with the team members, manage and coordinate responses to dossier-related health authority questions for defined markets In conjunction with appropriate functions, identify and ensure management of external documentation support when required Champion of Quality and Shapes Culture Contribute to the development of effective documentation processes and standards; in conjunction with cross-functional teams, implement to ensure compliance Participate in project and/or functional leadership opportunities; assist with pressure testing submission timelines and processes at governance bodies Champion the GSRD organization across multiple functions and identify meaningful synergies Proactively share knowledge and key learnings within GSRD and within and across Development Teams