Senior Scientist - Toxicology

Senior Scientist - Toxicology

Southern Research + You

Southern Research has been translating science into real-world solutions since 1941. Join our innovative team and enjoy benefits like medical, dental, vision, 401(k) match, life insurance, PTO, an employee assistance program, and more.

The Senior Scientist functions as a subject matter expert within the Preclinical Operations Division and has oversight of the scientific elements of projects to ensure successful implementation and/or study completion of toxicology studies. This position will also serve as Study Director and analyzes and reports results for publication or to sponsor, provides scientific instruction to other members of the project team, and collaborates with other senior members of the staff on projects/research.

Individuals filling this position must be and remain knowledgeable of emerging trends and may contribute to and influence best practices within the discipline.

• Oversees and serves as a Study Director/SME for preclinical operations to execute model and assay development, validation experiments, and GLP/non-GLP toxicology studies.
• Performs role of Toxicology Scientific Subject Matter Expert (SME)/Principal Scientist on commercial or government contracts and grants.
• Lead and execute all phases of Toxicology Investigational New Drug (IND) programs, including study designs, regulatory strategies, data interpretations, and submission preparations.
• Oversees capability expansion, assay and model development, and validation experiments to grow the Toxicology program.
• Drafts, reviews, and provides expert guidance on scientific and technical scopes of work for IR&D, government, commercial funding proposals, ensuring alignment with strategic objectives and compliance with sponsor requirements.
• Partners with Business Development, Project Management, and Proposals to ensure successful client engagement, proposal development, study execution, and contract deliverables throughout each phase of project.
• Within defined policies and procedures, provides resolution to complex scientific problems within a specified program.
• Supports Business Development as Toxicology SME on assigned projects. Interfaces with client's scientific staff as appropriate.
• Writes and assists in execution of validation plans.
• Mentors and trains internal preclinical team members as appropriate
• Supports troubleshooting issues during the conduct of toxicology studies.
• Monitors projects and programs, reviews toxicology data, and authors toxicology study reports, or portions thereof, as appropriate.
• Participates in proposal generation and performs scientific/technical review of proposals.
• Follows Good Laboratory Practices (GLP) and other appropriate regulatory (e.g., OECD, ICH) requirements to ensure all experimental data, including observations of unanticipated findings, are accurately recorded and verified. Ensures compliance to all regulatory and safety requirements for work with biologic agents.
• Observes appropriate safety and study requirements by reading, understanding, and following Standard Operating Procedures (SOPs), GLP regulations, and study protocols.
• Accountable for revenue generation as part of Toxicology program
• Support cross-functional initiatives and perform other duties as needed to advance Study Management program objectives.
• Authors/revises SOPs, as appropriate.

• Education & Experience
  • PhD degree in life sciences discipline with 4 years' prior experience; or
  • Master's degree with 6 years' prior experience; or
  • Bachelor's degree with 10 years' prior experience
• DABT preferred or will obtain within 12 months upon hire.
• Preferred 2-4 years' of CRO experience.
• Expertise in design, execution, interpretation, and reporting of GLP regulated toxicology studies.
• Has advanced the field of knowledge in his/her specialty. Work directly impacts the present or future of the organization in significant ways.
• Demonstrated competency in regulated environment (e.g. GLPs, BMBL).
• Previous experience serving as Study Director for general toxicology and other types of studies.
• Ability to work in Biosafety Lab Level…