Sage Therapeutics

Senior Scientist (Toxicologist), Nonclinical Development

3 months ago
# of Openings


General Scope and Summary


SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for an important role that is responsible for the design and oversight of the nonclinical safety testing programs for assigned clinical candidates in development.


Roles and Responsibilities

  • Responsible for nonclinical study design, contract research laboratory (CRO) selection/study director interactions/monitoring, study result interpretation, report finalization, and preparation of integrated nonclinical summaries for IND and NDA submissions.
  • Design safety testing program (including safety pharmacology, pharmacokinetics, and toxicology testing) for assigned clinical candidates.
  • Review and finalize study reports as per GLP’s.
  • Serve on selected project teams and/or sub teams.
  • Assess mechanism(s) of toxicity to determine clinical relevance and ways to minimize clinical impact.
  • Collaborate with Discovery Research in the screening and selection of final IND candidates.
  • Prepare all relevant nonclinical regulatory documents (study summaries, CTD tables, and integrated summaries) and respond to questions from Regulatory Authorities.
  • Provide perspective on safety concerns prior to and during clinical trials.
  • Work cross-functionally across the organization, including Regulatory, Discovery Research, Clinical Research, Quality Assurance, and Manufacturing groups.

Experience, Education and Specialized Knowledge and Skills


  • Successful candidates will have a MS or Ph.D. with 5+ years of experience as a toxicologist within the biopharmaceutical industry. 
  • Candidates must be familiar with the worldwide nonclinical testing guidelines to support clinical development and registrational filings.
  • Experience in developing IND testing programs and in preparing IND and NDA/MAA filings critical.  Knowledge of pharmacokinetics or toxicology specialization is desirable.
  • This role requires approximately 20% travel.
  • Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
  • Excitement about the vision and mission of Sage.


Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed

Need help finding the right job?

We can recommend jobs specifically for you! Click here to get started.