Sage Therapeutics

  • Scientist / Senior Scientist, Toxicology

    Job Locations US-MA-Cambridge
    Posted Date 2 weeks ago(10/9/2018 10:00 AM)
    ID
    2017-1520
    # of Openings
    1
    Category
    Research & 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) study director interactions/monitoring, study result interpretation, report finalization, and supporting preparation of integrated nonclinical summaries for IND
    • Design safety testing program (including safety pharmacology and toxicology testing) for early discovery and 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.
    • Work cross-functionally across the organization, including Regulatory, Research, Medical Science/Safety, Quality Assurance and CMC groups.

    Experience, Education and Specialized Knowledge and Skills

    • Successful candidates will have a MS with 5-10 years or Ph.D. with 1-3 years of experience as a toxicologist within the biopharmaceutical industry.
    • Candidates must be familiar with IND testing programs and the worldwide nonclinical testing guidelines to support clinical development and registrational filings.
    • 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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