Senior Director, Toxicology

General Scope and Summary

SAGE Therapeutics is seeking a seasoned Toxicologist to lead our toxicology and safety pharmacology studies for non-clinical R&D. 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 and serve as a subject matter expert (SME) and group leader for Toxicology with the responsibility of mentoring, developing, and overseeing team members within the function.

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.

• Serve as the group leader for Toxicology with the responsibility of mentoring, developing, and overseeing team members within the function.

• 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, Nonclinical Pharmacology and Safety Assessment sections of INDs, CTAs, and/or NDAs.

• Participate on multidisciplinary Drug Discovery teams.

Education, Experience 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, and good conflict management and negotiation skills. Must excel in a multidisciplinary environment as an integral leader and team member across several project teams. Excellent problem solving ability and attention to detail are critical. Must have a demonstrated ability to translate strategy into action while employing strong consensus-building skills, as well as the 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 DVM and a minimum of 10+ years of relevant experience.

• Experience working on small molecule pharmaceutical drug candidates required.

Preferred Qualifications

• Board certification (DABT or DABVT) preferred.

• Effective organizational, interpersonal, communication, and managerial skills; able to motivate and inspire others.

• Neuroscience toxicology experience and 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, and 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).

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.

All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

EEO is the Law

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We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Sage Therapeutics, Inc.