Glaukos Corporation · 4 months ago
Sr. Scientist II -Toxicology
Aliso Viejo, CA, United States
Full-time
Onsite
Senior Level, Lead/Staff
$109K/yr - $142K/yr
8+ years expGlaukos Corporation is seeking a Sr. Scientist II in Toxicology to provide expertise and leadership in toxicology and nonclinical development. The role involves designing and executing in vivo toxicology studies, contributing to nonclinical development plans, and ensuring compliance with regulatory submissions.
Health CareMedicalWellness
Responsibilities
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Evaluating published/unpublished data and providing risk evaluation on new ingredients for regulatory submissions and clinical trials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 pre-clinical settings
Establishes the development plan for nonclinical toxicity studies needed to satisfy clinical, internal and regulatory requirements. As Study Monitor, designs studies to maximize the quantity and quality of data and ensure adequate safety information is obtained from the study. Schedules and executes toxicology studies based on project priorities to ensure orderly and timely progression within set target dates
When acting as Study Monitor, assumes oversight for the technical conduct of studies and collaborates with the Study Director to assure that all aspects of studies are performed in accordance with Good Laboratory Practices (GLP) regulations, when specified, as mandated by the FDA. Serves as key contact for outsourced studies and assures that studies are executed according to protocol, SOP and contract
Evaluates CROs and obtains study bids/quotes, develops study protocols
Reviews and summarizes study data to provide interpretation, conclusions, and recommendations
Reviews and approves the interpretation, analysis, documentation and reporting of results of nonclinical studies by CROs to assure accurate safety assessments of drugs and devices
Reviews and approves summaries of safety evaluations prepared for internal research release documents, regulatory agencies (IND summaries) and clinical investigator brochures
Authors relevant sections of regulatory documents (i.e. IND, NDA)
Provides subject matter expertise and leadership in toxicology and nonclinical development at the team and development project level
Participates in project team meetings. Provides scheduling and technical input and plays an integral role in the project functional development plans
Proactively communicates with the team leaders and members on a regular basis and promptly notifies functional head and team leaders of issues
Evaluates available information/literature and provides technical expertise to assess and advise on the safety of new ingredients, compounds, acquisitions and competitor products
Prepares risk assessments and summaries for support of various research, clinical and regulatory activities. Exercises good judgement in recommending issues related to safety
Qualification
Required
8 years min. medical device or pharmaceuticals
M.S. degree in Biological Sciences and/or toxicology with +10 years of experience
A PhD Biological Sciences and/or toxicology +8 years of experience
At least 4 years of understanding and working with GLP and working in a pre-clinical setting
Broad understanding Good Laboratory Practices, care policies and FDA regulations
Skilled use of ocular anatomy, physiology and toxicology principles, theories and concepts
Excellent analytical and communication skills, both verbal and written
Excellent interpersonal skills, emotional intelligence and ability to negotiate
Some travel required
Company
Glaukos Corporation
At Glaukos, our focus is to develop and lead the global ophthalmic market with novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases—therapies that advance the existing standard of care and enrich the lives and treatment alternatives for patients worldwide.
1001-5000 employees
H1B Sponsorship
Glaukos Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (6)
2023 (1)
2022 (3)
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$121MKey Investors
Meritech Capital PartnersOrbiMed
2015-06-25IPO
2013-02-07Series F· $30M
2012-10-03Debt Financing· $6M
Leadership Team
Alex Thurman
Senior Vice President and Chief Financial Officer
Joseph Gilliam
President & Chief Operating Officer
Recent News
thefly.com
2026-01-16
Company data provided by crunchbase