Bristol-Myers Squibb Company

Study Director/Study Monitor

Location
New Brunswick, NJ
Posted
Sep 14, 2019
Ref
R1517575
Required Education
Bachelors Degree
Position Type
Full time

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.

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.

Summary

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.

Responsibilities

Main focus of role will be to act as Study Director and Study Monitor for general toxicology studiesconducted internally or at a Contract Research Organization (CRO), respectively

Ensure nonclinical studies are conducted in compliance with approved study protocols, Standard OperatingProcedures (SOPs), and, if appropriate, Good Laboratory Practice (GLP) regulations

Ensure compliance with all company/departmental policies, as well as other federal, state and corporatepolicies and guidelines

Create an atmosphere of scientific excellence, open communication, and creativity in order to maximizeproductivity

Continuously evaluate and apply new scientific methodology in order to maintain scientific or technicalexcellence, 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 establishedtimelines 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 theapproved 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, andregulatory requirements

This will include observing critical study activities (e.g. first dose administration), reviewing trainingrecords of study staff, and reviewing study data

Maintain regular contact with CRO Study Director to ensure up-to-date knowledge of study status andfindings

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 andreports 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 andbioanalytical 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

Position Requirements

BS, MS, or PhD in toxicology or related discipline with at least 3 years of experience in the conduct oftoxicology 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, especiallyclinical and functional changes associated with toxicity

Effective written and oral communication skills, especially as they pertain to writing clear and accuratetoxicology 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)

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.

Location
New Brunswick - NJ - US

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.