Bristol Myers Squibb Company

Research Fellow, Toxicology

Location
New Brunswick, NJ, United States
Posted
Sep 13, 2020
Ref
R1528416
Required Education
Doctorate/PHD/MD
Position Type
Full time
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 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 Summary:

We are seeking an experienced, skilled scientist to fill the role of Research Fellow in Nonclinical Safety Project Leadership (NSLP). The primary responsibility will be to act as the project toxicologist in support of compounds 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 as well as mentor junior scientists. Details about the job responsibilities and qualifications are shown below.

Responsibilities:

In the capacity of NCS project toxicologist:
  • Independently design and implement the toxicology strategy for supported programs.
  • Ensure studies are performed in accordance with overall program timelines.
  • Communicate significant toxicology findings to NCS management and program teams in a timely manner.
  • Write and critically review submission documents such as CTD sections for INDs and NDAs, Investigator Brochures, PIPs, briefing books, etc. to support clinical trials and drug registration globally.
  • As needed, respond to non-clinical 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 for supported compounds with regard to scientific design and regulatory compliance (GLP, animal welfare and safety).
  • As needed, act as Sponsor study monitor for outsourced toxicology for supported program.
  • Provide scientific collaboration to exploratory and discovery groups within Nonclinical Research and Development 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 in 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 the toxicology subject matter expert for due diligence evaluations of potential in-licensing opportunities.
  • Create an atmosphere of scientific excellence, open communication, and creativity in order to maximize productivity.
  • Ensure compliance with Good Laboratory Practice regulations and all company/department Standard Operating Procedures.
  • Embrace/demonstrate BMS Core Behaviors.


Requirements:
  • PhD (or equivalent) degree in Toxicology, Pharmacology, or a related discipline. Diplomate of the American Board of Toxicology (DABT) is preferred.
  • Minimum 15 years appropriate post-degree experience or equivalent scientific background in the biopharmaceutical industry, including experience with toxicology testing across multiple modalities (e.g. 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 Good Laboratory Practice 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 EMEA guidances related to nonclinical assessment of drug candidates.


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.