Next Science is a growing R&D company that strives to solve unsolved healthcare problems with gracefully simple solutions. This is an office-based position that will provide technical guidance to project managers and other R&D team members during the design process to ensure products, including accessories and packaging, are biologically safe for use in the desired markets. The toxicologist will provide support throughout the lifetime of the product and serve on risk assessment teams.
This position will report to the Clinical Research Director of Next Science in the Research and Development group. The ideal candidate possesses strong technical writing skills, relevant industry experience, and can strategize unique solutions to toxicology studies and related issues.
The person in this role is responsible for independently designing, contracting and reporting safety pharmacology and toxicology studies and integrating these data into human and animal health risk assessments to support new product development and regulatory filings. This position will be responsible for preparing and overseeing technical documentation that meet regulatory standards for both drugs and devices (i.e. ISO 10993 experience preferred).
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. This is an office-based position that will involve the overseeing of off-site studies but involves no physical lab work.
· B.S. in toxicology and/or pharmacology; M.S. or Ph.D. preferred
· 5 years of relevant industry experience
Experience preparing biocompatibility risk assessments
· 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 toxicology
- Keeps current with worldwide regulations for assessing safety of veterinary and human use 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.