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278 💼 Bristol Myers Squibb Science Jobs / Employment

Engagement Strategy Lead

newabout 1 hour ago
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Engagement Strategy Lead Summary The Engagement Strategy Lead is a matrix leader with strong therapeutic area knowledge and portfolio expertise responsible for leading a team in the development of disease-specific recruitment strategy that focuses on creating a positive site and patient experience in BMS clinical trials. Additionally, the incumbent should have a keen interest in exploring, identifying and implementing innovative new approaches which support our clinical trial sites and patients. The Engagement Strategy Lead will have strong stakeholder management and communication skills and serves as the single point of accountability and contact for internal and external stakeholders fo

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Associate Director - Translational Research

newabout 2 hours ago
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Bristol-Myers Squibb R&D is a science-driven, passionate organization determined to discover, develop and deliver medicines that have the potential to transform the lives of patients and establish new standards of care in areas of high unmet need. Patients’ needs and scientific discovery are our driving force. The new Bristol-Myers Squibb research site in Cambridge’s Kendall Square will position our scientific team in the heart of a vibrant ecosystem of world-class science, innovation and business opportunities. Our scientists will focus on novel targets and pathways for tumors that are refractory to current Immuno-Oncology therapies. These are significant challenges that will require innovative solutions from the biopharma, biotech and academic communities. Role / Responsibilities We are seeking an experienced scientist to join our Translational Research group in our new state-of-the-art facility. The qualified candidate is a highly motivated, interactive, and creative individual that possesses the ability to work across a highly matrixed environment to advance the translational research efforts. The candidate will be expected to lead a team of scientists and effectively collaborate with colleagues in the oncology, immunology and immuno-oncology groups, as well as liaise with the wider translational medicine, discovery and clinical teams. To be at the forefront of elucidating and overcoming resistance to IO therapies, should encourage scientists who are passionate problem solvers and thrive on a challenge that is clinically-vital to consider this opportunity. Qualifications MD, PhD or MD/PhD in Cancer Biology, or equivalent advanced biology degree Experienced scientist with 5-10 years’ of post-graduate research experience, with a minimum of 3 years in a drug discovery or translational setting Minimum 3 years’ recent experience in leading scientific teams in an academic or industry setting Ideally candidate will have in-depth knowledge / understanding of various mechanisms of therapeutic response and resistance utilizing in vitro, in vivo (and potentially ex vivo) patient-derived models Participated in clinical studies to better characterize the molecular underpinnings of therapeutic resistance in patient cohorts and correlation with clinical outcome A track record of independent critical thinking and scientific achievement demonstrated by first authorship in recent high impact publications Exposure to cancer immunotherapy including immune-checkpoint blockade with knowledge of current therapeutic landscape is highly desirable Knowledge of immune-phenotyping by flow cytometry would be beneficial Experience in balanced experimental design, data visualization and basic statistical analysis are desirable Prior role in multidisciplinary projects and teams with ability to integrate cross-functional information, desired but not required Experience with managing CRO relationships and collaborating with KOL’s would be advantageous Excellent interpersonal skills and ability to communicate, both written and oral effectively and efficiently within the BMS organization and with external partners/collaborators Thrives in fast-paced, dynamic work environment, bringing a pro-active mentality to the role

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Associate Director - Global Quality Clinical Trials and Safety

newabout 2 hours ago
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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, including Global Clinical Operations and Global Regulatory, Safety & Biometrics (GRSB) personnel, monitoring the status of the project(s) to plan audits and assuring GQ - CT&S leadership as informed. · Represent GQ-CT&S as an expert in specific GCP/PV related areas Key Responsibilities and Major Duties · Within multiple areas of GCP/PV expertise, act as an expert resource;trainer for GQ-CT&S and as liaison with key stakeholders to provide input into related audit strategy and plans · Within areas of expertise, maintain awareness of trends and new developments internally and externally · Perform GCP and PV audits, including audits of clinical investigator sites, vendors, internal systems and clinical study reports to assess regulatory compliance; · Apply audit principles, procedures, and methods; Collect information through effective interviewing, listening, observing and reviewing documents, records and data; · Prioritize and focus on matters of significance; · Confirm the sufficiency and appropriateness of audit evidence to support audit findings and 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; · Maintain audit database · Review and assess (or support the review) received corrective and preventive action plans according to specified timelines to ensure resolution of audit findings and prevent recurrence. · Maintain an in-depth knowledge of governmental regulations impacting clinical research and PV and development of medicines. · Provide advice and counsel concerning GCP regulatory requirements. · Act as project-specific liaison (Project Coordinator) and provide input into audit plans and strategy. · Regularly evaluate key PV and clinical research processes to determine compliance with regulatory requirements and established standard operating procedures. · May provide mentoring for new GQ-CT&S staff, as needed. · Support upper management on the on-boarding of new hires · Represent GQ-CT&S position during internal and external meetings · Lead project related teams or workstreams as assigned · Act as an advisor and back up to the Director · Coordinate health authority inspections as assigned and maintain inspection tools repository 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 internally and externally (investigator sites, vendors, etc.) in the conduct and reporting of audits. · Regular collaboration with GQ-CT&S colleagues and with GCO and GRSB personnel · Possible interactions with external auditors and Regulatory Agency inspectors during the conduct of health authority inspections either at clinical sites or at BMS facilities. · Miscellaneous contacts as assigned by GQ-CT&S management List of minimum requirements o Degree/Certification/Licensure o Bachelor´s degree required - Life Sciences degree preferred o Experience/Responsibility and minimum of years: o Demonstrated expertise and specific technical knowledge of the GCP and PV areas subject to audit, as evidenced by at Ieast 8 years in the pharmaceutical industry o Minimum 5 years technical auditing and/or related experience; PV and GCP auditing preferred o Competencies/Knowledge/skills o Strong skill in risk based prioritization o Strong critical thinking to analyze complex situations and discern critical issues and non-compliant situations and to recommend appropriate corrective and preventive actions; o Excellent understanding of the drug development process and end to end quality process o Support GQ-CT&S management on identification of areas to increase department efficiency o Demonstrates computer literacy and is able to function independently within an environment that relied heavily on technology for information and communication o Excellent oral and written communication; o Fluent in English (and other languages, as applicable to assigned audit region); o Sense of diplomacy and discretion; o Maintains the confidentiality and security of information, data and records; o Demonstrates commitment to delivering high-quality work product; o Knowledge of governmental regulations impacting clinical research and drug development o Understand the appropriateness and consequences of using sampling techniques for auditing; o Ability to make ethical, scientifically sound recommendations, consistent with company policy/strategy and cost effective; o Demonstrates flexibility, open-mindedness and adaptability to a rapidly changing environment; o Develops strong working relationships with key stakeholders; o Ability to manage competing priorities. o Ability to lead change process within functional group o Possesses detailed knowledge of areas of expertise and could teach or mentor others o Develops and applies new methods and ideas to enhance performance BMS Behaviors and Working conditions: o BMS Biopharma Behaviors required: Passion, Accountability, Innovation, Speed o Travel Required (nature and frequency) approximately 25% travel to perform audits and attend professional meetings and seminars. o Overnight Absences Required (per typical month): Approximately 5 days per month Software that must be used independently and without assistance (e.g., Microsoft Suite, Electronic Trial Master File, Oracle clinical database, RAVE, Trackwise, Sharepoint, etc

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Associate Director, Center of Observation Research and Data Sciences

newabout 2 hours ago
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The Associate Director, Research, is an individual contributor responsible for performing non-interventional research projects in support of key customer groups including Worldwide HEOR, PV&E, regional and local HEOR teams, WW Medical and others. Project work includes support of protocol development, identification of appropriate data sources, execution of protocol-related programming, analysis and summary of data and collaboration with customer on presentation of results. In addition, this role will supply methodological expertise on non-interventional research methods to the Center of Observational Research & Data Sciences (CORDS) team and the broader BMS outcomes research community, serve as a knowledge resource for the data development team, work with the Director, Research, to coordinate therapeutic area support and communication, and mentor Manager, Research staff. 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 Group Director, 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 Director, CORDS 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, 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

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Hybridoma Leader / Associate Director Hybridoma

newabout 2 hours ago
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We are looking for a highly motivated leader to lead the hybridoma effort within the Antibody Generation group. This is an exciting opportunity to make a significant impact within a department that is driving the biologics pipeline within BMS. The successful candidate is expected to evaluate novel antigen and immunization strategies and optimize the hybridoma workflow with an emphasis on utilizing recombinant methods to capture diverse antibody repertoires. Major responsibilities: Develop and optimize the existing hybridoma cloning workflow. Expand the scope of applications of hybridoma protocol and harmonize it with associated supporting automation and molecular rescue platforms. Continue to refine hybridoma processes to generate leads from transgenic and wild-type animals. Explore novel antigen design and immunization protocols. Fully integrate NGS and recombinant antibody generation workflows in hybridoma group in collaboration with molecular rescue and assays group. Be a champion in the lead discovery process and collaborate closely with biology project leaders to progress discovery projects Excellent written and oral skills are necessary Accomplish goals under project team timelines Qualifications: Ph.D. in molecular biology or immunology with 6-8 years of industry experience or an advanced degree with 10 years of relevant experience. Significant experience in antibody generation techniques from hybridoma is required. Experience with leading and developing teams of ≥4 FTE is required. Proficiency in B-cell biology, antigen design, and immunization protocols is required. Experience in analyzing humoral immune response using flow cytometry, HTRF, ELISAs is also required. In-depth knowledge of antibody repertoire sequencing and data analytics is desirable. Highly innovative and self-motivated. Excellent time management and organizational skills. Demonstrated ability to work in a multidisciplinary biologics discovery team

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Associate Director, Center of Observational Research and Data Sciences

newabout 2 hours ago
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The Associate Director, Research, is an individual contributor responsible for performing non-interventional research projects in support of key customer groups including Worldwide HEOR, PV&E, regional and local HEOR teams, WW Medical and others. Project work includes support of protocol development, identification of appropriate data sources, execution of protocol-related programming, analysis and summary of data and collaboration with customer on presentation of results. In addition, this role will supply methodological expertise on non-interventional research methods to the Center of Observational Research & Data Sciences (CORDS) team and the broader BMS outcomes research community, serve as a knowledge resource for the data development team, work with the Director, Research, to coordinate therapeutic area support and communication, and mentor Manager, Research staff. 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 Group Director, 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 Director, CORDS 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

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Associate Director - Clinical Pharmacology & Pharmacometrics

newabout 2 hours ago
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Role Overview: 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: 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 3 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, ADAPT, Gastroplus or Simcyp is highly desirable. Strong communication and project management skills required. Experience in biologics, and oncology, is a plus

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Associate Director, Medical Scientist

newabout 2 hours ago
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The BMS Medical organization strives to be recognized throughout the world as the most accomplished and respected BioPharma Medical organization. In BMS Medical, you will have the ability to impact the lives of patients by developing and ensuring the safe and appropriate use of our medicines. The Medical organization plays a valuable and unique role in unlocking the full potential of our scientific and medical innovation. Medical bridges clinical development with clinical practice and gains broader knowledge of the healthcare industry. The US I-O Medical Scientist and tumor lead for GI cancers plays a critical role in forging broadly aligned tumor strategies, translating them into tactical plans, and leading the execution of these plans. Critical Responsibilities include Demonstrate forward thinking by understanding emerging trends, anticipate future obstacles, risks, and business opportunities, and proactively create strategies, tactics, and contingency plans Collaborate with GI Development and Headquarter Medical teams in the development of long-term tumor strategies Lead the US cross-functional medical matrix teams in the development and execution of US medical plan Partner with US Commercial & Access organizations to integrate medical perspectives into the commercialization process and ensure appropriate alignment between commercial and medical Contribute to shaping the competitive strategies by communicating the US perspective for the target product profile, label language and value considerations Be the content expert of the assigned tumor, lead the development of field resources, and conduct effective training for field teams Identify data gaps, develop strategies for US non-registrational data generation, and lead the review, approval, and timely execution of investigator sponsored research Develop and maintain long-term, trusted relationship with external thought leaders and investigators Requirements Advanced scientific degree (MD, PhD, PharmD) Prior pharmaceutical industry experience in medical or clinical research Familiarity with all phases of oncology drug development, including clinical development, regulatory and life cycle management, is desirable Therapeutic area scientific & clinical expertise is desirable Experience in leading complex projects and diverse, high performance teams Strong interpersonal skills to navigate complex situations and build alignment with key stakeholders Demonstrated ability to execute and deliver results in a deadline-driven environment Clear and effective verbal & written communication skills Bristol-Myers Squibb is an equal opportunity employer. M/F/V/D Qualifications Experience in pharmaceutical industry

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Director/Lead, Immuno-Oncology Publications & Scientific Content

newabout 4 hours ago
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Summary of Responsibilities Structure, Scope & Accountability: · Reports to WW Head Medical Publications & Scientific Content · Leads a team accountable for creation of timely & relevant medical communications to advance understanding of the science & maximize value for customers (publications, field medical slides, Q&A documents and standard responses to customer questions) · Serves as a member of the WW Publications & Scientific Content leadership team & extended member of Medical Capabilities organization · Critical role accountable for ensuring the clear, accurate and scientifically rigorous communication of BMS information that informs medical practice for drug development & commercialization · Responsible for vision, strategy and execution of medical and scientific information exchange plans/platforms; including medical publications and content · Sets the goals and objectives for team, working closely with full development and medical leaders · Represents BMS scientific communications to external investigators, key authors and journal editors · Direct impact on the success of BMS Integrated Oncology organization (ie. timely journal submissions / publications, Congress presentations, Field Medical scientific content) · Leads an organization of approximately 4-8 full-time and contract experts, with a budget of between $1-3million · Partners internally to ensure team has necessary resources · Makes key decisions during the publication and scientific content development process · In the case of partnerships/alliances, manages the relationship and takes accountability for the combined success · Partners internally to identify, set timing and execute data dependencies and related disclosures of information in multiple communication channels including publications & scientific content · Partners externally with 3rd party vendors to ensure the appropriate balance of internal and external execution of work · Evaluates, collaborates and leads the partnership with many agencies to achieve objectives · Works extensively with Senior Leaders across the globe (R&D, Commercial, Medical) to develop publication and content plans that support the overall strategic communications asset strategy in a very competitive environment · Facilitates the alignment of medical publications and scientific content plans/platforms with internal matrix stakeholders, external key opinion leaders and approval by internal governing bodies · Presents and maintains alignment with matrix stakeholders on accomplishments, trends and book of work · Identifies and drives opportunities to standardize medical publications & scientific content · Identifies and drives opportunities to increase value and better leverage medical publications & scientific content · Manages the budget for defined area of responsibility Leads team for a I/O publications/content accountable for the following: · Delivering medical publications plans, publications, congress presentations, creating medical and scientific content. Scientific content is used for BMS medical professionals, call centers and field medical teams (in scientific exchange directly) · Reviewing draft publications and scientific content · Adjusting publications and medical content plans in accordance with clinical trial results/milestones and changes in the market healthcare landscape · Monitoring the external medical and scientific information landscape and for leading internal process improvements to stay the leader in the field, and enable BMS to be viewed as the top partner of choice by healthcare professionals · Fostering collaborative relationships with academic & clinical experts, authors, publishers, medical associations & other relevant stakeholder groups; including participating in external initiatives to foster trust and respect amongst academic and medical publishing community · Establishing and regularly communicating clear metrics aligned to meeting customer needs and demonstrating desired outcomes of activities · Identifying trends in content inquiry and aligning and adjusting to relevant trends to better meet customer needs · Ensuring compliance with internal and external standards · Identifying relevant data for content requests · Soliciting expertise when necessary to address a content request Collaboration: · Represents the Publications & Scientific Content through collaborations with senior leaders across the enterprise on cross-functional initiatives aimed at improving the overall efficiency, effectiveness, simplification, focus and integration of the business · Partners across the Medical Capabilities to obtain critical insights and ensure relevant customer focused content · Collaborates strongly across Leadership team & builds credibility and represents BMS in a strong manner with external thought leaders & collaborative partners · Demonstrates true medical & scientific information functional subject matter expertise & credibility (e.g, CMPP certification, ISMPP active member) to serve as an educator to internal & external audiences · Demonstrates scientific subject matter expertise in a specific tumor type/therapeutic area/phase Management: · Identifies, hires, develops, coaches high potential employees to ensure a rich pipeline of engaged, empowered and enriched talent · Creates a high performing, externally focused team which emphasizes teamwork, cooperation, personal accountability and a commitment to quality · Models BMS behaviors and reinforces such behaviors at all levels in the organization · Provides oversight and approval of partnerships with vendors and contract support to support and optimal and flexible workforce Experience Desired · Advance scientific degree, PharmD, PhD or MD preferred · 7 - 10 years of Pharmaceutical/Healthcare industry experience with a focus on medical communications · Demonstrated strength in leading teams to high performance · Proven ability to take decisions and build credibility with external investigators & collaborative partners, evidenced by strong behaviors and excellence in the science · Proven ability to work in an ambiguous environment, and develop a function with a focus on quick deliverables. · Experience collaborating across a matrix, multiple markets and global geographies · Experience participating in, facilitating and leading cross-functional, cross-cultural project teams · Demonstrated success driving optimal business results in a large complex corporate environment with multiple priorities and tight timelines · Demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation and interpersonal skills in a cross-functional team · Ability to think strategically in a changing environment · Entrepreneurial skill and ability to take educated risk · Ability to rise above technical expertise; demonstrating judgement, wisdom and understanding of impact · Experience leading functions, individuals and peers through change · Experience leading publications and scientific content development across all phases of the drug development and commercialization process · Certification as a Medical Publication Professional (CMPP) desirable · Medical writing experience · Ability to analyze and interpret clinical data · English fluency Knowledge Desired · Pharmaceutical/Healthcare Industry · External Compliance/Transparency/Conflict-of-Interest regulated work environments · Good Scientific & Medical Information practice and guidance; especially publications and content standards of practice · Sunshine Act · Pharma Code of Conduct, global guidance and regulations related to post-marketing practices and scientific data communication · Understanding of clinical trial design and execution, statistical methods and clinical trial data reporting requirements

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Associate Director Pharmacoepidemiology

newabout 4 hours ago
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Job Summary: • Directly supervises the work in one therapeutic areas (TA), • Prioritizes activities across multiple projects in the assigned TA and effectively negotiates plans with colleagues and customers. • Communicates the role of pharmacoepidemiology within GPV&E and throughout BMS. • Ensures TA epidemiologists apply theoretical principles to real problems and bridge uncertainty of the real world with innovative pharmacoepidemiologic solutions. • Ensures TA team epidemiologists evaluate risk-benefit of pharmaceuticals in context of worldwide regulatory agency use of epidemiologic data. • Advises on pharmacoepidemiology principles to others in R&D. • Ensures that all tasks are performed in the most efficient manner possible commensurate with quality, accuracy, and timeliness; and in accordance with current global regulatory requirements, good pharmacoepidemiology guidelines, and BMS cost effectiveness goals. Qualifications: • PhD in epidemiology or (MD, DO), MPH, at least 3-5 years’ experience in the pharmaceutical industry, some management experience preferred

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Associate Director, Biostatistics, Innovative Medicines Development

newabout 4 hours ago
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Position Description and Responsibilities This individual is a member of cross-functional development teams and will support Biostatistics TA Head of Immunoscience to provide expert and independent statistical leadership in support of the development of Tyk2 in IBD indications (such as Crohn’s disease and ulcerative colitis), including guidance on statistical methods, appropriate study design, data analytical approaches and interpretation of results. Support the Biostatistics TA Head to ensure execution of development strategy of Tyk2 with respect to development of indication-specific methodology, study designs, data collection, reporting and interpretation as well as regulatory and HTA interactions. Develops an effective partnership with the Biostatistics Asset Leads (BAL) to ensure the team’s ability to execute with quality in agreed to timelines. Provide statistical guidance/oversight to BAL at the strategic partner. Demonstrate a high degree of knowledge regarding the asset including knowledge of the underlying disease(s) and potential mechanism(s) of action, as well as current treatment landscape, up-to-date scientific literature and issues related to regulatory submission history of related products. Utilize data mining techniques to explore historical data to enhance development strategy for Tyk2 in IBD. Collaborate effectively with colleagues from multiple drug development functions by driving statistical thinking, and proper data interpretation. Influence the broader organization with respect to innovation in clinical study design Position Requirements Ph.D. (or equivalent) in Statistics or related field. Seven years or more in Pharmaceutical/R&D or other related experience, including supporting regulatory filings in multiple regions (e.g. US, EU, Japan). Experience in planning for & participating in regulatory meetings, (e.g. US FDA). Expertise in general & cutting edge statistical/clinical trials methodology & ability to apply to relevant clinical development framework. Demonstrated ability in solving complex statistical problems. Excellent verbal and written communications skills. Ability to work successfully in cross-functional teams leading to successful global regulatory filings and approvals. Strong communication/presentation skills with ability to tailor the message to the key stakeholder for effective impact and influence. Ability to be flexible and adapt quickly to the changing needs of the organization. Ability to organize multiple work assignments and establish priorities. Demonstrated ability to operate and lead in a matrix organization, building successful working relationships and effective stakeholder management in an environment with multiple lines of authority and competing needs. Experience in development of compounds in IBD preferred

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Director, Clinical Pharmacology and Pharmacometrics

newabout 4 hours ago
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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. This individual will apply their Clinical Pharmacology and Drug Development expertise to the development of small molecule and biologic assets in immunology that help patient prevail over serious autoimmune disease conditions. This individual will also provide broad clinical pharmacology and pharmacometrics strategic leadership to early and late stage assets. This person will play a central role in the planning, designing, executing, interpreting and reporting of healthy subject and patient studies conducted in early, full and life cycle stages of development. Provide critical input on the design and execution of Clinical Pharmacology plans and be able to create a robust human Clinical Pharmacology profile by integrating results from a broad spectrum of non-clinical, clinical and model-based assessments. In addition, this individual will be responsible for generating modeling and simulation plans, conducting population pharmacokinetic and exposure-response analyses for the assets, and managing analyses conducted by pharmacometrics vendors ensuring timely delivery of deliverables. This individual will serve as the Clinical Pharmacology subject matter expert on cross functional asset teams and provide his/her functional expertise during health authority interactions and regulatory submissions. Position requirements are as follows: Ph.D. in pharmaceutical sciences, biomedical engineering, or a PharmD with a clinical pharmacology research fellowship. A minimum of 7 years of experience gained through direct industry experience in Clinical Pharmacology is required. The successful applicant will have experience in developing clinical pharmacology plans and in the preparation of regulatory submissions (including INDs, NDAs, BLAs and/or significant sNDAs/sBLAs). This person will have experience in responding to regulatory questions related to all aspects of clinical pharmacology. This individual will have knowledge and experience in the application of current practices in the areas of clinical pharmacology, pharmacokinetics, drug metabolism, bioanalysis, biopharmaceutics, regulatory affairs, and toxicology. Strong oral and written communication skills necessary to formally present and report information internally and externally is required. The ability to work in a dynamic team oriented environment is essential

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Director, Clinical Pharmacology and Pharmacometrics

newabout 4 hours ago
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This individual will have responsibility for leading the clinical pharmacology support of BMS oncology and immuno-oncology assets. This person will play a pivotal roles in the design, planning, execution and interpretation of studies conducted in early, full and life cycle management phases of clinical development. She or he will have responsibility for the management and oversight of the clinical pharmacology profiling of small molecule and biologic oncology drugs. The individual will act as the study director on clinical pharmacology focused studies in healthy volunteers and patients, including: drug-drug interactions; biopharmaceutics; special population studies; ADME; thorough QT; and biocomparability studies. The successful applicant will be responsible for the design and implementation of the Clinical Pharmacology plans using traditional and model informed drug development approaches and will manage the clinical study process from protocol development to final study reporting. The person filling this position will serve as the clinical pharmacology representative and subject matter expert on internal development coordinating bodies. This individual will be responsible for the preparation of the Clinical Pharmacology components of regulatory submissions and will represent the Clinical Pharmacology line at meetings with regulatory agencies and health authorities. The requirements for the position include a Ph.D. in pharmacology or pharmacokinetics or a PharmD with a clinical pharmacology research fellowship. A minimum of 7 years experience gained through direct industry experience in Clinical Pharmacology is required. Experience as a Study Director contributing to the pharmacokinetic and pharmacodynamic aspects of clinical protocol design, writing, data interpretation, review and reporting is a prerequisite. Experience in oncology and the development of small molecules and biologics as well as in the use of pharmacometric and model guided drug development techniques is also desirable. The successful applicant will have experience in developing clinical pharmacology plans and in the preparation of regulatory submissions (including INDs, NDAs, BLAs and/or significant sNDAs/sBLAs). This person will have experience in responding to regulatory questions related to all aspects of clinical pharmacology. This individual will have knowledge and experience in the application of current practices in the areas of clinical pharmacology, pharmacokinetics, oncology, drug metabolism, bioanalysis, biopharmaceutics, regulatory affairs, and toxicology. This individual will have strong communication and project management skills and demonstrate a successful record of leadership in a matrix organization and as a 1st line supervisor and mentor.

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Associate Director, Immuno-Oncology Customer Insights & Market Research

newabout 4 hours ago
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This role is responsible for leading design and execution efforts, customizing research methodologies to deliver and embed strategic customer insights and drive improved decision-making for the US I-O Solid tumor business (HCC, CRC and Gastric). Key Responsibilities and Major Duties Provides leadership for Customer Insights efforts, developing and deploying innovative market research techniques that reflect best practices, in order to develop key strategic customer insights and drive superior decision-making Accurately assesses business issues faced by I-O Solid and develops the appropriate market research design to address them, providing superior analysis and reasoned solutions Ensures customer insights are effectively and efficiently communicated. Identifies opportunities and risks, and through the facilitation of discussions with brand teams translates them into actionable recommendations Proactively creates opportunities to embed insights and influence decision-making in brand teams Demonstrates mastery of primary research designs and analysis, and independently develops customized non-standard research solutions to address complex, multi-faceted tactical and strategic business issues Develops Market Research plans aligned to business need through collaboration with Immuno-Oncology BI&A and brand teams, creating synergies and eliminating duplication List of Minimum Requirements Bachelor of Science in relevant area; Advanced degree in General Business, Finance, Economics, Market Research, Operations Research, Statistics, or Engineering preferred 5-8 years of relevant market research experience Pharmaceutical industry experience strongly preferred Consulting experience working with a national consulting firm strongly preferred Experience in the key functional areas of market research, including design and analysis of primary market research, secondary data analysis and modeling, required Experience with both strategic and operational research techniques and business issues Experience delivering superior analysis and embedding insights to drive business decisions Exceptional analytical and strategic thinking skills; concise and impactful written and verbal communication skills Demonstrated ability to proactively partner with and influence others within and across functional teams Ability to work in a face-paced environment, handle multiple projects simultaneously and deliver high quality business results within tight deadlines Consistently strong demonstration of Core BMS Behaviors

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Associate Director of Clinical Trial Analytics

newabout 4 hours ago
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Leads a team of specialists who are in charge of clinical trial enrollment/randomization, performance forecasting and tracking for Phase I to IV clinical trials across all therapeutic areas Provides strategic leadership and oversight for the analytic aspects of the clinical trial performance at all stages of drug development at a variety of internal forums, increase understanding of metrics and forecasts, particularly with respect to timeline analytics Responsible for resource utilization and demand management in the Metrics and Reporting group Represents the Clinical Trial Analytics perspective across GCO and beyond Interacts with Operations Leads, Protocol Managers, Site Managers and other stakeholders as appropriate Provides strategic direction and oversees the creation of recruitment dashboards, enrollment projections, Eclipse reports, and ad hoc custom outputs Manages vendor relationships, creates strategy for long term engagement and identifies solutions for short term deliverables Dynamically leverages the existing contractor pool to maximize performance and manage workload peaks. Fully responsible for the assigned team’s development, coaches and mentors them according to their needs Accountable for driving continuous improvement and innovation in the Metrics and Reporting team and at the CT Analytics level. Identifies areas for improvement and acts as a sponsor or contributor to work streams and other CI initiatives. Strategic planning and coordinated implementation of Digital Health partnership projects, and building a comprehensive analytic ecosystem for better trial planning and execution support Qualifications Requirements: Masters degree in public health, epidemiology, health care or other life-sciences. 5 years experience in clinical trial management or clinical trial information support. Strong understanding of clinical trial processes. Experience with country and site selection, trial feasibility, performance tracking and vendor management. Experience with Digital Health activities including RWD/EMR, patient matching, precision Site and Country selection Experience with strategic solution planning, vendor selection and integrated implementation Skills: Strong people management and inter-personal skills. Excellent presentation of insights Customer focus Attention to detail Experienced with information systems and clinical trial intelligence and supporting data Extremely proficient with MS Office (Word, Excel, ppt). VBA, ORACLE, SAS or R is a plus Ability to handle multiple projects Strong analytical competencies Exposure to, and understanding of epidemiological, healthcare, commercial and clinical data sets as it relates to clinical trial planning and execution

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Research Investigator II, In Vivo

new4 days ago
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Research Investigator II, In Vivo Research Investigator - In Vivo Pharmacology in Immunosciences Drug Discovery Summary of BMS: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 import

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IT Business Partner, Process Robustness

4 days ago
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…IT Business Partner Analyst, Process Data Analytics in the GPS IT Plan organization. Bristol - Myers Squibb is the industry leader in immuno-oncology with

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Analytical CMC Leader

4 days ago
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Bristol - Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail

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Associate Research Scientist II

5 days ago
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…their goals, both at work and in their personal lives. Immuno-Oncology Discovery Team at Bristol Myers Squibb , Redwood City, CA, is seeking a highly

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Research Scientist

10 days ago
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Research Scientist Research Scientist Company 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. Position The department of Immuno-Oncology Discovery at Bristol Myers Squibb, Redwood City is seeking a highly motivated Research Scientist to join a group of researchers evaluating novel therapies in the field of cancer immunotherapy. The candidate will characterize immuno-modulatory antibodies, and explore mechanism of action and combinatorial therapeutic strategies. Qualifications Master degree in immunology, oncology or related field and a minimum of 4 years

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Research Investigator, Late Stage Translational Bioinformatics Oncology

13 days ago
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Bristol - Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail

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Principal Scientist, Cancer Drug Discovery

15 days ago
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Principal Scientist, Cancer Drug Discovery This Principal Scientist position will join the Cancer Resistance Biology Research Team at Bristol-Myers Squibb in Cambridge, MA to lead preclinical drug development against therapeutic targets at the intersection of intrinsic tumor genetics and the extrinsic tumor microenvironment. Summary The qualified candidate is a highly motivated, interactive, and creative individual who possesses substantial experience in studying tumor biology and genetics, and experience or strong interest as to how these features impact immune responses to the tumor. The candidate will be an experienced program team leader and drug hunter. S/he will be an effective ma

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Senior Scientist - Analytical Strategy

16 days ago
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Summary: The Senior Scientist - Analytical CMC Strategy lead support serves as the point of a contact and contributor for BMS on the strategy & technical leadership for Biological Product assets in the Analytical Science & Technology organization (a member of the Biologics Operations Division). This role requires individual contributions and leadership of a matrix team of analytical scientists supporting commercialized and late-stage biopharmaceutical products with a focus on establishing the analytical CMC strategy, enabling regulatory filings, providing technical partnership for testing laboratories around the world, managing the life cycle of products and specifications (methods and acceptance criteria), and authoring/reviewing responses to health authority questions on commercial products. Duties/Responsibilities: This position will be located at the Bristol-Myers Squibb site in Devens, MA. The Senior Scientist will collaborate across BMS sites with Analytical Science and Technology teams, Manufacturing Science and Technology, Analytical Development, Global Quality product leads, technical project teams, and Regulatory leads to generate and execute the commercial strategies for drug substance and drug product methods and specifications, network analytical control strategies, and support of product life cycle regulatory filings. The Senior Scientist will be responsible for contributing and/or leading a matrix team responsible for preparation of licensure applications, rest of world filings, follow-up measures, and prior approval submissions. Through strong leadership, the Senior Scientist will ensure the support of analytical methods and analytical change control across the BMS network, for third party manufacturing and our partners at outside testing labs. Additional responsibilities include: Create and maintain effective partnerships with stakeholders from Analytical Development, Manufacturing Sciences and Technology, Supply Chain, Regulatory, Quality, Process Sciences, Drug Product Development, Project Management, and Manufacturing to deliver analytical strategies with a high probability of technical and regulatory success. Functions as an individual contributor for analytical activities for late-stage and commercial programs in support of strategic decisions. Operates within a matrix analytical team to support during all BLAs, ROW & PAS filings and reviews, and works with Analytical Development in supporting the responses to FUMs and PMCs. Co-leads the effort to implement effective control strategy, analytical method and specification change control as needed throughout the BMS network, third party manufacturing and outside testing labs. Coordinates optimization and improvement of analytical program support. Serves as project expert during inspections QUALIFICATIONS: Specific Knowledge, Skills, Abilities, etc: Demonstrates a broad expertise and knowledge in analytics routinely used for in-process, release and stability testing of Biologics or Protein Therapeutics drug substance and drug product. Experience in product characterization and strategies to stablish process and product knowledge. Strong communication and leadership skills in a highly interactive environment. Demonstrated skills in working across-functional strategic teams and collaboration with internal and external partners. Strong knowledge of biologics CMC regulations and cGMP requirements, as well as, experience in supporting regulatory filings. Demonstrated participant or lead of matrix teams of scientists and/or project management professionals. Education/Experience/ Licenses/Certifications: A PhD, MS, or BS in Biological Sciences, Chemistry, or related disciplines with at least 4, 10 or 13years of industrial experiences in relevant fields, respectively. Physical Demands This is primarily a coordination role for a commercial program, including office work, teleconferencing, computer work, and running meetings, as well as working with quality control analysts in a laboratory setting. Including … Sitting Walking-Level Surfaces Work Environment This is primarily a coordination role for a commercial program, including office work, teleconferencing, computer work, and running meetings, as well as working with quality control analysts in a laboratory setting. Including … Inside Work Working Alone Working with/around others Chemicals Travel This position may require approximately 25% travel. Supervisory Responsibilities No direct reports (but leading in a matrix organization).

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Sr. Research Investigator or Principal Scientist

18 days ago
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Sr. Research Investigator or Principal Scientist 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 varie

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Associate Scientist

23 days ago
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**About Bristol - Myers Squibb ** Bristol - Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver

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Senior Scientist, Single B Cell Technology (36)

about 1 month ago
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We are looking for a highly motivated Senior Scientist to join the lead discovery effort within the biologics department in Redwood City, CA. This is an exciting opportunity to make a significant ...

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Research Scientist In-Vivo Pharmacology

about 1 month ago
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S. with a minimum of 5 years of industrial experience with strong scientific knowledge and research experience in in vivo pharmacology, cancer biology, immuno-oncology, or immunology is highly ...

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Research Associate- In Vivo Pharmacology

about 1 month ago
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... group at Bristol-Myers Squibb in Cambridge, MA and aide in the advancement of early stage ... capable of presenting scientific results to multidisciplinary teams and key stakeholders

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Research Investigator II

about 1 month ago
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Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop ... The position will require strong scientific background and proven leadership ability with a strong ...

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Global Search & Evaluation Lead, Fibrosis

about 1 month ago
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Global Search & Evaluation Lead, Fibrosis The candidate will be responsible for search activities, subsequent initial technical evaluation, and leading due diligences of potential transactions for both licensing and M&A, primarily within fibrotic diseases. Within BMS, the candidate will be required to lead business development activities in the fibrosis area and work with key internal stakeholders to facilitate transactions. The candidate will also need to lead strategically at all times, especially externally in the sourcing of potential new assets for BMS, but also internally in the oversight and coordination of evaluation and diligence with internal subject matter experts. Most

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Associate Director of Clinical Trial Analytics

about 1 month ago
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Associate Director of Clinical Trial Analytics Leads a team of specialists who are in charge of clinical trial enrollment/randomization, performance forecasting and tracking for Phase I to IV clinical trials across all therapeutic areas Provides strategic leadership and oversight for the analytic aspects of the clinical trial performance at all stages of drug development at a variety of internal forums, increase understanding of metrics and forecasts, particularly with respect to timeline analytics Responsible for resource utilization and demand management in the Metrics and Reporting group Represents the Clinical Trial Analytics perspective across GCO and beyond Interacts wi

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Hybridoma Leader / Associate Director Hybridoma (28)

about 1 month ago
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Hybridoma Leader / Associate Director Hybridoma (28) Hybridoma Leader Hiring Manager: Antibody Generation Leader We are looking for a highly motivated leader to lead the hybridoma effort within the Antibody Generation group. This is an exciting opportunity to make a significant impact within a department that is driving the biologics pipeline within BMS. The successful candidate is expected to evaluate novel antigen and immunization strategies and optimize the hybridoma workflow with an emphasis on utilizing recombinant methods to capture diverse antibody repertoires. Major responsibilities: Develop and optimize the existing hybridoma cloning workflow. Expand the scope of application

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Protocol Management Line Manager

about 1 month ago
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Protocol Management Line Manager 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 competitiv

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Research Scientist I

about 1 month ago
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Research Scientist I The Research Scientist I will join the Immuno-Oncology Discovery team at Bristol-Myers Squibb in Redwood City, CA and aide in the advancement of early stage therapeutic targets. The qualified candidate is a highly motivated, interactive, and creative individual that possesses the ability to work across a matrixed environment to advance preclinical drug development programs from target identification/validation through IND enabling activities. The candidate will be expected to effectively collaborate with colleagues in the oncology, immuno-oncology, protein engineering, and antibody development groups. The successful candidate will demonstrate clear and professional ve

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Lead, Scientific and Regulatory Writing

about 1 month ago
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Lead, Scientific and Regulatory Writing 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

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Scientist, Antibody Generation (55)

about 1 month ago
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Scientist, Antibody Generation (55) Summary We are seeking a Scientist with hands-on experience in antibody discovery using hybridoma and/or B-cell approaches to support therapeutic biologics programs and reagent antibody generation. Responsibilities will include designing and executing on immunization and screening strategies to generate panels of antibodies that meet the required criteria as well as diverse panels of antibody sequences and epitopes where needed. The candidate must have in-depth knowledge of current state-of-the art antibody generation technologies and be able to apply this to practice at the bench. In depth understanding of immunology, cell biology, and molecular biolog

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Research Scientist 1

about 1 month ago
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Research Scientist 1 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,

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Field Medical Scientist - UT, CO, NE, KS, NM, MO

about 2 months ago
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About Bristol-Myers Squibb: Bristol-Myers Squibb is a global biopharmaceutical company whose ... science or accelerate access, optimize medical practice, and drive appropriate adoption of BMS ...

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Associate QC Scientist (Equipment Qualification, Lifecycle Management)

about 2 months ago
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Bristol - Myers Squibb is seeking top talent for our Quality organization. The purpose of this evergreen req is to gather qualified candidates for an expected

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Group Leader - Biologics Analytical Methods

3 months ago
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Bristol - Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail

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Associate Scientist/Engineer

3 months ago
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The role of the Associate Scientist/Engineer is to conduct experiments for the purposes of providing robust and timely technical support for commercial upstream biopharmaceutical manufacturing ...

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Research Scientist

about 1 year ago
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Research Scientist Company Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious ...

jobs byZipRecruiter

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