Study Director/Study Monitor - Nonclinical Toxicology

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Nonclinical Research and Development (NCRD) is an integrated function with responsibility for characterizing nonclinical safety and disposition characteristics of the entire BMS Research and Development pipeline programs, with critical role from early discovery to submission of marketing authorization applications. We utilize our deep expertise in toxicology/pathology, ADME, PK/PD, biopharmaceutics and Bioanalytics in all modalities (small and large molecules, cellular therapies and other novel modalities) to collaborate with peer R&D functions to identify and solve issues, discover high quality drug candidates, enable their clinical development and successful marketing authorizations across the globe.

Position Responsibilities

In this role, you will act as Study Director or Study Monitor for general toxicology studies conducted internally or at a Contract Research Organization (CRO), respectively. You will be 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, you will collaborate with internal and external support groups including, but not limited to, Nonclinical Safety (NCS) Management, 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 CRO, respectively

• Ensure nonclinical studies are conducted according to the highest standards of science, quality, and animal welfare and in compliance with approved study protocols, SOPs, and, if appropriate, 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 Project Representatives and NCS 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), 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 Project Representative and NCS 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 NCS management

As both Study Director and Study Monitor, collaborate closely with internal and external support groups, including but not limited to Project Representatives and colleagues within Pathology, analytical and bioanalytical laboratories, Veterinary Sciences, and Discovery Toxicology.

• 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

Basic Qualifications

• Bachelor’s Degree and 5+ years of academic and / or industry experience

OR

• Master’s Degree and 3+ years of academic and / or industry experience

OR

• Ph.D. or equivalent advanced degree in the Life Sciences and no experience necessary

Preferred Qualifications

• At least 3 years of experience in the conduct of toxicology studies required for the product registration

• 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)

• Position level will be commensurate with experience/qualifications

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.