Project Toxicologist

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.

When you join BMS, you are joining a diverse, high-achieving team united by a common mission. 

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.

Here, you’ll get the chance to grow and thrive through opportunities that are uncommon in scale and scope. You’ll pursue innovative ideas while advancing professionally alongside some of the brightest minds in biopharma.

We are seeking an experienced, skilled individual to fill a role of a project toxicologist in the Nonclinical Safety Portfolio Leadership (NSPL) group. The primary responsibility will be to act as the project toxicologist in support of small and large molecule programs across early- and late-stage development and across multiple therapeutic areas. In this role, the person is expected to provide scientific and strategic input for supported programs, ensure toxicology efforts are aligned with the overall development strategy, independently author summary documents to support regulatory submissions and, when necessary, lead investigative efforts to resolve nonclinical safety issues. In addition, the person in this role will actively participate in scientific discussions within Nonclinical Safety (NCS) for all compounds across the portfolio.

Key Responsibilities

• In the capacity of NSPL project toxicologist:

• Independently design and implement the toxicology strategy for supported programs

• Ensure studies are performed in accordance with overall program timelines

• Communicate toxicology findings to NCS management and program teams in a timely manner

• Write and critically review submission documents such as CTDs, INDs, NDAs/BLAs, IBs, PIP/PSP, briefing books, etc. to support clinical trials and drug registration globally

• As needed, respond to nonclinical toxicology questions from worldwide regulatory authorities

• As needed, lead multidisciplinary investigative efforts to address/resolve program-related toxicology issues/concerns

• Review and edit toxicology study protocols and reports with regard to scientific design, interpretation and regulatory compliance (GLP, animal welfare and safety)

• Provide scientific collaboration to discovery groups within Nonclinical Research and Development (NCR&D) to help evaluate and nominate drug candidates with minimal or predictable toxicity profiles

• Actively participate in NCS-wide scientific discussions for compounds across the portfolio

• Provide mentorship to junior scientists within NCS

• Continuously evaluate and apply new scientific methodology in order to maintain scientific excellence, to increase productivity, to meet our research and drug registration needs, and to minimize or resolve toxicity-based problems with company products or those under development

• Act as a toxicology subject matter expert for evaluations of potential in-licensing opportunities

• Create an atmosphere of scientific excellence, open communication, and creativity to help achieve company and departmental goals

• Ensure compliance with Good Laboratory Practice (GLP) regulations and all company/department Standard Operating Procedures (SOPs)

• Embrace/demonstrate BMS Core Behaviors.

Basic Qualifications

• Bachelor's Degree 8 years of academic / industry experience

or

• Master's Degree6 years of academic / industry experience

or

• PhD4 years of academic / industry experience

Preferred Qualifications

• PhD (or equivalent) degree in Toxicology, Pharmacology, or a related discipline. Diplomate of the American Board of Toxicology (DABT) is preferred.

• At least 3 to 5 years of appropriate post-degree experience or equivalent scientific background in the biopharmaceutical industry, including experience with toxicology testing across multiple modalities (eg, small molecules, biologics, oligonucleotides).

• Strong scientific and leadership skills

• Experience serving as a toxicology representative on cross-functional development and discovery teams across different stages of development. Late-stage project experience is a plus.

• Knowledge of GLP regulations

• Experience interacting with global Health Authority (FDA, EMA, PDMA, etc) via face-to-face meetings, teleconferences, and written communication.

• Knowledge of biochemical and mechanistic toxicology, and ability to design and interpret studies exploring mechanisms of toxicology involving biochemical, functional, and/or structural endpoints.

• Knowledge of human risk assessment, as it pertains to drug development.

• Effective written and oral communication skills, especially as they pertain to writing clear, and accurate documents for global regulatory submissions and health authority responses.

• Ability to effectively communicate and interact with co-workers at all levels and to work independently and on teams.

• Participation on cross-industry consortium efforts (DruSafe, EFPIA, etc) considered a plus.

• Strong understanding of ICH, FDA and EMA guidances related to nonclinical assessment of drug candidates.

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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.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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