Job description
SAGE Therapeutics is seeking a seasoned Toxicologist to lead our toxicology and safety pharmacology studies for non-clinical R&D. Reporting to the Chief Scientific Officer, 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.
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 externded Sage Toxicology and Safety pharm team
Negotiate budgets with CRO’s; ensure their timely conduct and delivery of reports
Prepare regulatory submissions and maintain regulatory submissions (annual reports, IBs, INDs and CTA’s)
Aid in the preparation of responses to inquiries from regulatory agencies, Investigator's Brochure, nonclinical Pharmacology and Safety Assessment sections of INDs, CTA's and/or NDAs
Participate on multidisciplinary drug discovery teams
Must thrive working in a fast paced innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, 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. Demonstrated ability to translate strategy into action while employing strong consensus-building skills. Ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
Desired Skills and Experience
PhD in a scientific discipline or DVM and a minimum of 7 years relevant experience. 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 CRO’s
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)
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