SR. SCIENTIST II – TOXICOLOGY

The Sr. Scientist II, Toxicologist reporting to the Sr. Director of Toxicology and Biocompatibility is responsible for providing subject matter expertise and leadership in toxicology and nonclinical development at the team and development project level.

• The design, execution (including monitoring) and reporting on in vivo toxicology studies supporting the nonclinical development of new ophthalmic therapeutics and drug delivery devices and contributing to the regulatory submissions enabling their testing in clinical studies. These studies include safety/tolerability testing of novel formulation in nonclinical models.
• Contribute to the nonclinical development plan needed to satisfy clinical internal and regulatory requirements on a project basis.
• Participate in Project Team Meetings, and interfacing with internal/external scientists from other disciplines.
• Authors nonclinical study protocols and reports to support IND/IMPD/NDA/IMPD/PLA submission toxicology studies.
• Evaluating published/unpublished data and providing risk evaluation on new ingredients for regulatory submissions and clinical trials.
• Serving as a Study Monitor to ensure optimal testing requirements are implemented for each study. Providing interpretation and authoring research reports in compliance with GLP regulations to support the safety of new pharmaceutical, device, and combination products.
• Possessing a comprehensive understanding and hands-on experience in conducting different study types in diverse laboratory animal species.