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Southern Research · 3 months ago

Senior Scientist - Toxicology

Greater Birmingham, Alabama Area

Contract

Onsite

Mid, Senior Level

4+ years exp

Southern Research is an innovative organization that has been translating science into real-world solutions since 1941. The Senior Scientist in Toxicology will serve as a subject matter expert, overseeing the scientific elements of toxicology studies and functioning as Study Director. This role involves executing IND programs, providing scientific guidance, and collaborating with various teams to ensure successful project implementation.

BiotechnologyLife ScienceOncology

No H1B

Responsibilities

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

Qualification

Toxicology expertiseGLP regulated studiesStudy Director experienceCRO experienceDABT certificationDevelopmental toxicologyPlanningOrganizationCommunication skillsMentoring skillsProblem-solving skills