Associate Research Scientist
- Employer
- Bristol Myers Squibb Company
- Location
- New Brunswick, NJ, United States
- Start date
- Jun 21, 2019
View more
- Discipline
- Science/R&D, Biotechnology
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
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), respectively
Ensure nonclinical studies are conducted in compliance with approved study protocols, Standard Operating Procedures (SOPs), and, if appropriate, Good Laboratory Practice (GLP) regulations
Ensure compliance with all company/departmental policies, as well as other federal, state and corporate policies and guidelines
Create an atmosphere of scientific excellence, open communication, and creativity in order to maximize productivity
Continuously 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 studies
Prepare and ensure compliance with study protocols
Monitor and manage daily study operations
Ensure the proper organization and recording of study data
Evaluate and interpret test results and prepare written summaries and reports in accordance with established timelines and which meet regulatory requirements
Keep DSE project representative and management apprised of study findings and results
Prepare 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 designs
Coordinate review of protocols, reports, and amendments thereof with key stakeholders within BMS
Periodically travel to CROs to ensure studies are being conducted in compliance with protocols, SOPs, and regulatory requirements
This will include observing critical study activities (e.g. first dose administration), reviewing training records of study staff, and reviewing study data
Maintain regular contact with CRO Study Director to ensure up-to-date knowledge of study status and findings
Keep DSE project representative and management apprised of study findings and results
Work 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 requirements
Communicate potential issues related to CRO performance to DSE management
As 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 standards
Embrace/demonstrate BMS Core Behaviors
Ensure good housekeeping and a safe work environment by enforcing departmental policies and procedures
Perform other tasks/procedures as assigned by line management
Qualifications
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 registration
Position level will be commensurate with experience/qualifications
Knowledge of the general principles of toxicology, animal and human biology and physiology, especially clinical and functional changes associated with toxicity
Effective written and oral communication skills, especially as they pertain to writing clear and accurate toxicology reports
Ability to effectively communicate with co-workers at all levels and to work independently
Thorough knowledge of Standard Operating Procedures and Good Laboratory Practice Procedures
Knowledge of laboratory animal welfare standards (USDA, AALAC, etc.)
Role will involve 15-30% travel (US and Canada)
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.
At Bristol Myers Squibb, we believe in the power of science to address some of the most challenging diseases of our time. Our focus on these unmet needs comes during a remarkable time, when unprecedented scientific breakthroughs are advancing the treatment of disease as never before in human history.
We work every day to transform patients’ lives through science. Each day, our employees around the world work together for patients – they are at the center of everything we do. They inspire us. They are the reason we come to work each day.
We combine the agility of a biotech with the reach and resources of an established pharmaceutical company to create a global leading biopharma company powered by talented individuals who drive scientific innovation.
- Website
- http://www.bms.com/
- Phone
- +1-800-332-2056
- Location
-
430 E. 29th St
14th Floor
New York
New York
10016
United States
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