Associate Director, Toxicology

General Scope and Summary

SAGE Therapeutics is seeking a seasoned Associate Director, Toxicology to lead our toxicology and safety pharmacology studies for non-clinical R&D. Reporting to the Senior Director, Toxicology, the successful candidate will be expected to participate on multidisciplinary drug discovery teams where their role will be to plan, conduct, and interpret non-clinical toxicology and Safety Assessment studies.

Roles and Responsibilities

• Develop strategy for the non-clinical toxicology and Safety Assessment studies in support of Clinical Development.

• Manage toxicology and safety pharmacology studies for compounds in various stages of research and development.

• Identify CROs for studies, oversee protocol design, and serve as Study Monitor (single/repeat dose toxicity, DART, genotoxicity, carcinogenicity studies, etc.).

• Visit CRO sites to review facilities and capabilities of potential toxicology and safety pharmacology collaborators.

• Serve as the point on all toxicology and safety pharm issues; identify and perform due diligence on external Sage consultants, including coordination of all activities of extended Sage Toxicology and Safety Pharm team.

• Negotiate budgets with CROs; ensure their timely conduct and delivery of reports.

• Prepare regulatory submissions and maintain regulatory submissions (annual reports, IBs, INDs, and CTAs).

• Aid in the preparation of responses to inquiries from regulatory agencies, Investigator's Brochure, non-clinical Pharmacology and Safety Assessment sections of INDs, CTAs, and/or NDAs.

• Participate on multidisciplinary drug discovery teams.

Experience, Education and Specialized Knowledge and Skills

Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient. Must have excellent interpersonal skills, the ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, and the ability to analyze complex issues to develop relevant and realistic plans, programs, and recommendations. Must have a demonstrated ability to translate strategy into action, excellent analytical skills, and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.

Basic Qualifications

• PhD in a scientific discipline or Doctor of Veterinary Medicine (DVM) .

• 6+ years of experience in the biotech/pharmaceutical industry.

Preferred Qualifications

• Board certification (DABT or DABVT ) preferred.

• Experience working on small molecule pharmaceutical drug candidates required.

• Experience with the development of CNS candidates highly preferred.

• Ability to communicate clearly and effectively with management and CROs.

• An in-depth understanding of all aspects of pharmacology/toxicology with special emphasis on their application in drug discovery, as well as the ability to work in a team-based drug discovery/development environment.

• Strong reasoning ability in the identification of problems and the ability to draw conclusions and make responsible decisions.

• The ability to utilize and/or develop connections within the scientific community and utilize these resources in the resolution of issues.

• The ability to work in a matrix environment with cross-functional teams.

• Understanding of current existing guidelines, regulations, requirements, and standards (GLP, ISO, OECD, ICH).

• Embrace our core values: Put People First, Improve Lives, Cultivate Curiosity, Do Right, and Forge New Pathways.

• Excitement about the vision and mission of Sage.

All Sage new hires will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief. Requests for accommodation will be considered on a case-by-case basis, and Sage will consider, among other things, whether the proposed accommodation would create an undue hardship.

Benefits and Compensation

• The actual salary offered within the range is dependent on a variety of factors including, but not limited to, relevant experience, qualifications, education, skills, and performance.
• This position is eligible to participate in the Company’s annual bonus plan; the bonus varies based on performance and is subject to the standard terms and conditions of the incentive program.
• To support your well-being, we offer a comprehensive benefits and wellness package, which includes medical, dental, and vision coverage upon hire. More information can be found in our Benefits Guide.

• Base salary ranges are periodically reviewed and subject to change. #LI-Remote