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.