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Project Toxicologist
Posted on 9/9/2022
INACTIVE
Locations
Edison, NJ, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Creativity
Leadership
Management
Research
Writing
Requirements
  • Bachelor's Degree 8+ years of academic / industry experience
  • Master's Degree6+ years of academic / industry experience
  • PhD4+ years of academic / industry experience
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
Desired 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
Bristol-Myers Squibb

10,001+ employees

Biopharmaceutical development company
Company Overview
Bristol-Myers Squibb engages in the discovery, development, licensing, manufacturing, marketing, distribution and sale of pharmaceuticals.