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.