Description

Senior Scientist - Toxicology

Senior Scientist - Toxicology

Southern Research + You
Discover a career where your work truly matters. 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. General Summary 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. Essential Duties & 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.

Requirements/Minimum Qualifications

• 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 2 and 3.
• Accountable for some level of revenue generation.
• Prior experience in developmental and reproductive toxicology would be a plus.
• Must be eligible to work in the United States without employer sponsorship.

Core Values Cultivating human connection putting people first. We know that every individual makes a difference and that no one can do it alone. We believe the world's most powerful resource is human potential. We are an inclusive and courageous team where innovation and diversity of though go hand in hand. We understand that relationships move at the speed of trust. Operating with precise execution measuring what matters and owning results as a team. We leverage data to drive decisions that advance science. We recognize the importance of a stable foundation coupled with an agile mindset. We hold ourselves accountable and take pride in our work. We give and receive candid feedback as a gift that keeps us growing. Harnessing relentless curiosity our unstoppable, innovative force. We are driven to ask sharp questions and push the boundaries of knowledge. We use creativity and critical thinking as catalysts for finding solutions that change lives. We learn by doing, consistently striving to improve our relationships, training, methodologies, questions and results. Stewarding a healthy community implementing sustainable operations for a safe, engaging environment. We don't compromise on safety and health for our employees, customers or community. We believe a healthy community begins with inclusive economic opportunities. We respect the dignity of the patients we ultimately serve. We are motivated to serve communities that are underserved and markets that are overlooked. Job Specific Behaviors Coaches/Develops Others Uses appropriate interpersonal style to guide direct reports (if applicable) to action. Business Knowledge Maintains external awareness of technology or business sectors; supplies knowledge of organization's culture, business processes and tools to achieve goals. Operational/Technical Excellence Ensures that work product (whether service or process) enables the organization to deliver on customer's expectations. Planning and Organization - Systematically identifies issues to be addressed and plans a course of action for self and others to ensure the accomplishment of specific objectives. Continuous Learning - Targets learning needs; seeks learning activities; maximizes learning; applies knowledge or skill; and takes risks in learning. Communication Effectively communicates verbally with others, and written skills are effective. Quality Orientation - Follows procedures, ensures high-quality outputs and takes action. Innovation Challenges paradigms; thinks expansively; leverages diverse resources; evaluates multiple solutions; and ensures relevance. Adaptability Tries to understand changes; approaches change or newness positively; and adjusts behavior. Physical Demands This position requires the following physical abilities including (but not limited to):

• Performing work with utilizing a computer for extended periods of time.
• Sitting for extended periods of time without being able to leave the work area.
• Standing for extended periods of time without being able to leave the work area.

Certifications, Licenses & Registrations No certifications are required; however, training includes Good Laboratory Practices and annual training on safe handling of viruses. Radiation safety training may be required depending upon the assays utilized. DABT certification preferred but not required. Work Authorization
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

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