Sage Therapeutics

Senior Scientist (Toxicologist), Nonclinical Development

US-MA-Cambridge
4 weeks ago
ID
2017-1342
# of Openings
1
Category
Development

Overview

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.

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