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Study Director/Study Monitor

Company: Bristol-Myers Squibb Company
Location: New Brunswick
Posted on: August 9, 2019

Job Description:

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.Act as Study Director or Study Monitor for general toxicology studies conducted internally or at a Contract Research Organization (CRO), respectively. Responsible for ensuring the nonclinical studies assigned are conducted in compliance with approved study protocols, Standard Operating Procedures (SOPs), and, if appropriate, Good Laboratory Practice (GLP) regulations. As both Study Director and Study Monitor, collaborate with internal and external support groups including, but not limited to, DSE Management, DSE Project Representatives, Anatomic and Clinical Pathology staff, Veterinary Sciences staff, Discovery colleagues, and CRO Study Directors.Job Responsibilities:Main focus of role will be to act as Study Director and Study Monitor for general toxicology studies conducted internally or at a Contract Research Organization (CRO), respectivelyEnsure nonclinical studies are conducted in compliance with approved study protocols, Standard Operating Procedures (SOPs), and, if appropriate, Good Laboratory Practice (GLP) regulationsEnsure compliance with all company/departmental policies, as well as other federal, state and corporate policies and guidelinesCreate an atmosphere of scientific excellence, open communication, and creativity in order to maximize productivityContinuously evaluate and apply new scientific methodology in order to maintain scientific or technical excellence, to increase productivity, to meet our research and drug registration needs--As Study Director for in-house nonclinical toxicology studies:----collaborate with Biological Technicians and Study Supervisors; provide direction and encouragement in the performance of their job duties (as appropriate) during the conduct of nonclinical studiesPrepare and ensure compliance with study protocolsMonitor and manage daily study operationsEnsure the proper organization and recording of study dataEvaluate and interpret test results and prepare written summaries and reports in accordance with established timelines and which meet regulatory requirementsKeep DSE project representative and management apprised of study findings and resultsPrepare and submit study data to the departmental archivist--As Study Monitor for studies that conducted at CROs:------Provide study design forms to CRO Study Director and ensure that final protocols are aligned with the approved study designsCoordinate review of protocols, reports, and amendments thereof with key stakeholders within BMSPeriodically travel to CROs to ensure studies are being conducted in compliance with protocols, SOPs, and regulatory requirementsThis will include observing critical study activities (e.g. first dose administration), reviewing training records of study staff, and reviewing study dataMaintain regular contact with CRO Study Director to ensure up-to-date knowledge of study status and findingsKeep DSE project representative and management apprised of study findings and resultsWork with CRO Study Director to evaluate and interpret test results and ensure written summaries and reports are prepared in accordance with established timelines and which meet regulatory requirementsCommunicate potential issues related to CRO performance to DSE management--Is both Study Director and Study Monitor, collaborate closely with internal and external support groups, including but not limited to staff in DSE Project Representatives, Pathology staff, analytical and bioanalytical laboratory staff, Veterinary Sciences staff, and Discovery colleagues------Ensure internal and external studies are conducted in compliance with current animal welfare standardsEmbrace/demonstrate BMS Core BehaviorsEnsure good housekeeping and a safe work environment by enforcing departmental policies and proceduresPerform other tasks/procedures as assigned by line management--Minimal knowledge base/skill set and position requirements:------BS, MS, or PhD in toxicology or related discipline with at least 3 years of experience in the conduct of toxicology studies required for the product registrationPosition level will be commensurate with experience/qualificationsKnowledge of the general principles of toxicology, animal and human biology and physiology, especially clinical and functional changes associated with toxicityEffective written and oral communication skills, especially as they pertain to writing clear and accurate toxicology reportsAbility to effectively communicate with co-workers at all levels and to work independentlyThorough knowledge of Standard Operating Procedures and Good Laboratory Practice ProceduresKnowledge of laboratory animal welfare standards (USDA, AALAC, etc.)Role will involve 15-30% travel (US and Canada)--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.

Keywords: Bristol-Myers Squibb Company, New Brunswick , Study Director/Study Monitor, Executive , New Brunswick, New Jersey

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