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.

Qualifications

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• Evaluates published and unpublished data to assess safety risks associated with new ingredients, materials, formulations, and delivery technologies.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