This position will report to the Clinical Research Director of Next Science in the Research and Development group.
This position represents R&D on cross-functional product development teams. The person in this role is responsible for independently designing, contracting and reporting in-vitro and in-vivo toxicology programs and integrating these data into human and animal health risk assessments to support new product development and regulatory filings.
As a member of project teams, the toxicologist is responsible for cross-functional collaboration for project team deliverables, including leading sub-teams and task forces when required. The toxicologist will support in-line projects and independently prepare technical reviews and position papers to address drug, device, residue and other safety issues.
· B.S. in toxicology and/or pharmacology; M.S. or Ph.D. preferred
· 2 years of relevant industry experience
· Knowledge of bench, applied and regulatory toxicology
· Understanding of pharmaceutical and device development and human health risk assessments.
· Accomplished at technical writing
· Knowledge of Good Laboratory Practices (GLP); GLP Study Director experience is a plus.
· Possess the skills to successfully negotiate regulatory outcomes employing novel technical arguments
- Functions as in-house consultant and subject matter expert in areas of expertise
- Keeps current with worldwide regulations for assessing safety of veterinary compounds.
- Participates in presentations to regulatory agencies, when needed. Active participant in professional/technical associations.
- Functions as a Sponsor Representative on toxicology, safety, PK, exposure studies, as well as analytical supporting studies.
- Develops protocols and designs studies in collaboration with CROs. Conducts or directs all activities in compliance with established regulatory requirements.
- Evaluates, interprets, reviews and summarizes technical data. Prepares and reviews reports, memos, SOPs and regulatory documents with minimal oversight. Responsible for preparation of User Risk Assessments.
- Leads or participates effectively in teams and is able to shift priorities and projects as needed to align with functional, R&D and/or regulatory priorities.
- Excellent communication skills of writing and speaking to be effective on the job.
- Extensive experience defining toxicity and safety testing requirements and implementing programs.
- Working knowledge of international regulatory guidelines applicable to toxicity, safety and exposure studies, risk assessments and data interpretation by regulatory bodies.
- Act at all times according to industry and Company standards and ethics.
- Assure appropriate reporting of data to support complex regulatory submissions. As necessary, provide support for presentation and discussion of safety positions to regulators.