Bristol-Myers Squibb Company

Principal Scientist

Location
New Brunswick, NJ, US
Posted
Jun 28, 2018
Ref
R1507635
Required Education
Doctorate/PHD/MD
Position Type
Full time
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. 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.

We are seeking an experienced, skilled scientist to fill the role of Principal Scientist in the Department of Toxicology within Drug Safety Evaluation (DSE). The primary responsibility will be to act as the DSE project representative in support of compounds across early- and late-stage development 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, this role is expected to actively participate in scientific discussions within DSE for compounds across the portfolio as well as mentor junior scientists. Details about the job responsibilities and qualifications are shown below.

Job Responsibilities
In the capacity of DSE project representative:
  • Design and implement the toxicology strategy for supported programs
  • Ensure studies are performed in accordance with program timelines
  • Communicate significant toxicology findings to DSE management and program teams
  • Author toxicology summary documents for submission to worldwide regulatory authorities
  • As needed, respond to non-clinical toxicology questions from worldwide regulatory authorities.
  • As needed, lead 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, regulatory compliance (GLP, animal welfare and safety)
  • Provide scientific collaboration to exploratory and discovery groups within Research and Development to help evaluate and nominate drug candidates with minimal or predictable toxicity profiles
  • Active participation in DSE-wide scientific discussions for compounds across the portfolio
  • 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
  • Create an atmosphere of scientific excellence, open communication, and creativity in order to maximize productivity
  • As needed, act as Study Monitor for toxicology studies conducted at contract laboratories
  • Ensure compliance with all company/departmental policies, particularly those relating to animal welfare and employee safety and health
  • Embrace/demonstrate BMS Core Behaviors
  • Ensure good housekeeping and a safe work environment by enforcing departmental policies and procedures


Qualifications
  • PhD (or equivalent) degree with minimum 10 years appropriate post-degree experience or equivalent scientific background in the biopharmaceutical industry. Diplomate of the American Board of Toxicology (DABT) is preferred.
  • Experience serving as a toxicology representative on development and discovery teams across different stages of development, including participation in global Health Authority interactions.
  • Experience with toxicology testing of both small and large (biologics) molecules.
  • 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 applicable discipline.
  • Effective written and oral communication skills, especially as they pertain to writing clear, and accurate toxicology reports and summary documents for global regulatory submissions.
  • Ability to independently integrate and write nonclinical submission documents.
  • Ability to effectively communicate and interact with co-workers at all levels and to work independently and on teams.
  • Knowledge of Standard Operating Procedures, Good Laboratory Practice, worldwide and regulatory requirements, and drug development processes.