Sr. Scientist II -Toxicology

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 project level. What You’ll Do: Design, execute (including monitoring), and report on in vivo toxicology studies supporting the nonclinical development of ophthalmic therapeutics and drug delivery devices, contributing to regulatory submissions for clinical testing. These include safety/tolerability testing of novel formulations in nonclinical models. Contribute to nonclinical development plans to meet clinical and regulatory requirements. Participate in Project Team Meetings and collaborate with internal and external scientists from various disciplines. Author nonclinical study protocols and reports to support IND/IMPD/NDA/PLA submissions. Evaluate published and unpublished data, providing risk assessments for new ingredients in regulatory submissions and clinical trials. Serve as a Study Monitor to ensure proper testing procedures, interpret data, and author research reports in compliance with GLP regulations to support the safety of pharmaceutical, device, and combination products. Possess comprehensive hands-on experience in conducting different study types across diverse laboratory animal species. Design and execute nonclinical toxicity study plans 40% Develop nonclinical toxicity study plans aligned with project needs, maximizing data quality and quantity, minimizing animal use, and ensuring safety data adequacy. As Study Monitor, oversee study conduct, ensure compliance with GLP regulations, and collaborate with Study Directors. Evaluate CROs, develop study protocols, and obtain bids/quotes. Data review and reporting 40% Review and interpret study data, providing conclusions and recommendations. Approve the interpretation, analysis, and reporting of nonclinical study results by CROs. Review safety summaries for internal and regulatory purposes, including IND summaries and investigator brochures. Author sections of regulatory documents such as IND and NDA. Interdepartmental and project team participation 15% Provide toxicology expertise and leadership at the team and project levels. Participate in project meetings, providing technical input and contributing to development plans. Communicate proactively with team members and notify leadership of issues. Scouting, new opportunity evaluation 5% Assess new ingredients, compounds, and products through literature review and technical evaluation. Prepare risk assessments and summaries to support research, clinical, and regulatory activities. How You’ll Get There: Minimum 6 years in medical device or pharmaceutical industries. M.S. in Biological Sciences and/or Toxicology with over 10 years of experience. PhD in Biological Sciences and/or Toxicology with at least 6 years of experience. At least 4 years of experience with GLP and laboratory animal species. Broad understanding of laboratory animal sciences, GLP, animal care policies, and FDA regulations. Skilled in ocular anatomy, physiology, and toxicology principles. Excellent analytical, verbal, and written communication skills. Strong interpersonal skills, emotional intelligence, and negotiation abilities.

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