Bristol-Myers Squibb Company

Associate Research Scientist

Location
New Brunswick, NJ, United States
Posted
Jun 21, 2019
Ref
R1516282
Required Education
Bachelors Degree
Position Type
Full time
Position 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), 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)