The Senior Manager of Nonclinical Safety Assessment will support the safety assessment of potential compounds in various stages of development.  Responsibilities include contributing to regulatory submissions (INDs, SPAs, IBs, etc); liaising with CROs to request bids/proposals to conduct nonclinical toxicology studies; managing generation of work orders/POs/invoices for contracted studies; qualifying CROs and monitoring pivotal studies; managing/tracking timelines of studies; knowledge and understanding of GLPs; reviewing and finalizing protocols of diverse nonclinical safety studies; reviewing and interpreting data and revising, as necessary, CRO toxicology study protocols/reports to generate quality reports for regulatory submissions; participate in project teams to support toxicology strategy throughout development.


  • Deeply motivated self-starter with an entrepreneurial spirit
  • Desire to work in a quickly changing, fast-paced environment
  • Unrelenting dedication to delivering quality results
  • Being an integrity role model by visibly and consistently speaking and acting with superior moral values
  • Willing to roll up your sleeves to get the job done
  • Has an overall understanding and knowledge of diverse CROs
  • Able to work with CRO personnel and gain their trust and respect
  • Able to propose and explain toxicology strategy to project team, etc


  • PhD preferred, or BS/MS with equivalent experience
  • Toxicology board certification is a plus
  • 3-5 years pharmaceutical industry (or related industry), with knowledge and experience in aspects of drug development
  • Proven ability to manage multiple projects/tasks at one time
  • Excellent written and oral communication skills
  • Broad knowledge of pharmaceutical toxicology and its related disciplines (e.g. DMPK, pharmacology, disease biology) and non-clinical drug development (e.g. Manufacturing, Clinical, Regulatory)
  • Knowledge of drug development and life cycle management concepts and interdependencies with the overall development process
  • Ability to design study protocols, analyze and interpret data for safety studies with minimal supervision
  • Familiarity with GLP regulations and ICH, FDA and EMEA non-clinical safety guidelines


  • Self-motivation and an entrepreneurial spirit
  • Desire to work in a quickly changing, fast-paced environment
  • Unrelenting dedication to delivering quality results
  • Strong moral values and integrity in word and action
  • Willingness to roll up your sleeves to get the job done
  • Overall understanding and knowledge of diverse CROs
  • Able to work with CRO personnel and gain their trust and respect
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