Toxicology
Onsite in Aliso Viejo, CA Glaukos
3.6 Aliso Viejo, CA Job Details Full-time $118,500
$148,100 a year 15 hours ago Benefits Relocation assistance Qualifications Biology FDA submissions Research design Vendor selection

GLP DABT

Data quality assurance Risk mitigation strategy development Competitive analysis Project timeline management Investigational new drug (IND) applications Research project design Master's degree 8 years Pre-clinical study projects Collaboration with product development teams Research project technical leadership Analysis skills ICH guidelines Bachelor's degree Doctor of Philosophy Scientific protocols Decision making Data quality monitoring Laboratory compliance Quality compliance management Mentoring Vendor communication Data interpretation Project execution Full Job Description The Sr. Scientist II, Toxicology is responsible for leading and executing nonclinical toxicology programs supporting the development of novel drug delivery devices and combination products. This role provides advanced scientific expertise in the design, monitoring, interpretation, and reporting of toxicology and safety studies that enable clinical development and regulatory submissions. The position independently manages complex projects, collaborates extensively with multidisciplinary teams, and contributes to the development of nonclinical strategies aligned with program objectives. The Sr. Scientist II serves as a key scientific resource within Toxicology and influences decision-making through technical expertise, data interpretation, and risk assessment. Sr.

Scientist II, Toxicology How You'll Contribute:

The Sr. Scientist II, Toxicology is responsible for leading and executing nonclinical toxicology programs supporting the development of novel drug delivery devices and combination products. This role provides advanced scientific expertise in the design, monitoring, interpretation, and reporting of toxicology and safety studies that enable clinical development and regulatory submissions. The position independently manages complex projects, collaborates extensively with multidisciplinary teams, and contributes to the development of nonclinical strategies aligned with program objectives. The Sr. Scientist II serves as a key scientific resource within Toxicology and influences decision-making through technical expertise, data interpretation, and risk assessment.

What You'll Do:

Nonclinical Development & Study Leadership Leads the design, execution, monitoring, and reporting of nonclinical toxicology and safety studies supporting pharmaceuticals, drug delivery devices and combination products. Develops and implements nonclinical study strategies to support IND, IMPD, NDA, BLA and MAA submissions and clinical development programs. Evaluates published and unpublished data to assess safety risks associated with new ingredients, materials, formulations, and delivery technologies. Serves as Study Monitor for GLP and non-GLP studies, ensuring scientific quality, regulatory compliance, and alignment with development objectives. Designs scientifically robust studies that maximize data quality while promoting ethical animal use and regulatory compliance. Coordinates study timelines, priorities, and deliverables across multiple programs to support development milestones. Manages CRO relationships, including vendor selection, protocol development, bid evaluation, study oversight, and review of final reports. Data Interpretation & Regulatory Support Reviews, analyzes, and interprets nonclinical study data to generate scientifically sound conclusions and recommendations. Contributes to the preparation and review of toxicology sections for regulatory submissions, investigator brochures, and internal development documents. Identifies potential safety risks and develops mitigation strategies through integration of data from multiple disciplines and study types. Cross-Functional Collaboration & Technical Leadership Serves as the toxicology representative on cross-functional project teams and provides scientific input to development plans and program decisions. Collaborates closely with Chemistry, Engineering, Pharmacology, Pharmacokinetics, Regulatory Affairs, Clinical Development, and external partners Participates in regulatory interactions and supports responses to questions from global health authorities. Evaluates competitor products, emerging technologies, and scientific literature to inform program strategy and innovation opportunities. Provides mentorship and technical guidance to junior scientists and project team members as appropriate.

How You'll Get There:

Demonstrated expertise in GLP toxicology studies, laboratory animal sciences, FDA regulations, ICH guidelines, and nonclinical safety assessment. Proven ability to independently lead complex technical projects and exercise sound scientific judgment in study design and data interpretation. Experience managing external CROs and coordinating cross-functional development activities. Strong analytical, written, and verbal communication skills with the ability to communicate complex scientific concepts to diverse audiences. Demonstrated success contributing to regulatory submissions and supporting nonclinical development strategies. Bachelor's Degree in Toxicology, Biological Sciences, or related scientific discipline with 12+ years of relevant experience. Master's Degree in Toxicology, Biological Sciences, or related scientific discipline with 10+ years of relevant experience. PhD in Toxicology, Biological Sciences, or related scientific discipline with 8+ years of relevant experience. DABT certification preferred Willingness to travel around 15% This role works onsite in Aliso Viejo, CA Relocation assistance may be available #GKOSUS Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible. Founded in 1998, Glaukos Corporation is an ophthalmic pharmaceutical and medical technology company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases. Our mission at Glaukos is to truly transform vision by pioneering novel, dropless therapies that can meaningfully advance the standard of care and improve the lives of patients suffering from chronic, sight-threatening eye diseases. Innovation is at the core of everything we do, and we are resolute in our commitment to challenge conventional thinking with new treatment alternatives that are supported by real science, robust clinical evidence, and an unrelenting focus on patients. Our constant pursuit of game-changing technologies that disrupt legacy treatment paradigms is encapsulated in the Glaukos mantra \"We'll Go First,\" which articulates our willingness to take chances, our determination to forge new ground, and our commitment to continuous improvement in all that we do. Our company completed an initial public offering in June of 2015, and our shares are traded on the New York Stock Exchange under the ticker symbol \"GKOS\". Our global headquarters is in Aliso Viejo, California with additional locations in San Clemente, California, and Burlington, Massachusetts. Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer . All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law. 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Sr. Scientist II - Toxicology - Onsite in Aliso Viejo, CA