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Principal Scientist Toxicology
will provide full relocation competitive compensation package- bonus, STI, LTI and stock

About the Role: Principal Scientist Toxicology

 

Key role in the discovery and development of Company’s development compounds. Working with Company colleagues, participates in all stages of Toxicology/Safety Pharmacology assessment, from study planning through to regulatory submission. Will have expertise in either or both study management/oversight or interpretation of study results. Provides strategic and operations direction ensuring all studies are conducted in line with appropriate guidelines and regulatory testing standards and individual program objectives. May represent Toxicology on Development teams and regularly interfaces with colleagues to ensure timely study conduct and/or rapid and accurate dissemination of Toxicology/Safety pharmacology findings.

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Your Contributions (include, but not limited to):

  • Develops and implements plans for preclinical testing of new and current drug candidates
  • Selects and manages Toxicology and Safety Pharmacology CROs
  • Oversees and leads protocol preparation for Toxicology and Safety Pharmacology studies. Manages the conduct and reporting of individual studies, including study placement, contract development/budgeting, coordination of pre-study activities, and approving study protocols and reports
  • Performs thorough analyses/interpretations of Toxicology/Safety Pharmacology data and participates in go/no-go decision making
  • Prepares SOPs as needed to guide the Toxicology and Safety Pharmacology programs
  • Authors and/or reviews Toxicology and Safety Pharmacology sections of all regulatory documents, including IND, CTA, IB, annual report, and NDA/MAA submissions
  • Keeps up-to-date with current regulatory guidance
  • Collects, analyzes, interprets complex data, communicates results, and writes reports in a timely manner
  • Works collaboratively with other scientists, technicians and colleagues as part of multidisciplinary project teams
  • Performs quality control checks on non-clinical pharmacology and toxicology documents for regulatory submission
  • Assists in the preparation of documents and annual investigational new drug and new drug application reports
  • May provide support to build and maintain technical databases, archives and department procedures manuals
  • May lead lower level scientists and/or project teams
  • Other duties as assigned

Requirements:

  • Bachelors degree in life sciences or related field and 12+ years of experience in CRO and/or pharmaceutical industry in the conduct and/or oversight of small molecule Toxicology/Safety Pharmacology programs. Experience in managing preclinical Contract Research Organizations. Experience working in a cross functional team and matrix environment. Experience with preparation of INDs, CTDs, NDAs, and MAAs preferred OR
  • MS/MA degree Toxicology or related field and 10+ years of similar experience as note above OR
  • PhD in Toxicology or related field preferred and 4+ years of relevant experience; may include postdoc experience
  • DABT certification is desirable
  • Assimilates data and research findings outside of Company for application to new scientific projects
  • Maintains broad knowledge of scientific principles and theories and possesses intellectual mastery of one or more scientific areas
  • May develop an understanding of other areas and related dependencies
  • Advanced knowledge and demonstrated ability working with / recommending a variety of laboratory equipment/tools
  • Knowledge of preparation of INDs, CTDs, NDAs, and MAAs
  • Ability to work as part of and lead multiple teams
  • Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams
  • Excellent computer skills
  • Sees broader picture, impact on multiple programs, teams and/or departments
  • Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
  • Excellent project management skills
  • Proactive, innovative, with good problem-solving skills
  • Excellent written, presentation, and verbal communication skills

 

 

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