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About the Role
Serve as project toxicologist for multiple complex development programs across therapeutic areas and modalities, contributing to overall program development on interdisciplinary project teams. Design and implement safety assessment strategies to support program advancement and decision-making from discovery through regulatory milestones and later-stage development. Partner closely with cross-functional colleagues to design fit-for-purpose GLP and non-GLP safety programs. Synthesize complex datasets, leverage external literature, and develop clear weight-of-evidence positions for risk assessment and program decisions. Anticipate potential safety issues and design or lead investigative studies. Proactively manage potential safety liabilities and communicate impact. Contribute to and incorporate new approach methodologies (NAMs). Identify opportunities to refine study design and reduce animal use where scientifically appropriate. Author regulatory documents and presentations, representing the company in interactions with health authorities. Advance the external scientific standing through publications, presentations, and collaborations. Lead or support inter- and intra-departmental initiatives.
Responsibilities
- Serve as project toxicologist for multiple complex development programs across therapeutic areas and modalities and contribute to overall program development on interdisciplinary project team
- Design and implement safety assessment strategies to support program advancement and decision-making from discovery and candidate selection through regulatory milestones and later-stage development, as needed.
- Partner closely with pathologists, study operations professionals, translational scientists, pharmacologists, clinicians, and regulatory colleagues to design fit-for-purpose GLP and non-GLP safety programs that answer key development questions efficiently
- Rapidly synthesize complex or incomplete datasets, leverage the external literature, and develop clear weight-of-evidence positions that support risk assessment, dose selection, study design, and program decisions.
- Anticipate potential target-, modality-, or mechanism-related safety issues and design or lead investigative and mechanistic studies in collaboration with pathologists and subject matter experts.
- Proactive management of potential safety liabilities and communication of impact to teams, leadership, and governance committees
- Contribute to and incorporate new approach methodologies (NAMs) that strengthen translation and decision making.
- Identify opportunities to refine study design and reduce or replace animal use where scientifically appropriate, while maintaining robust safety assessment and regulatory readiness.
- Author regulatory documents and presentations; represent Translational Safety and Genentech/Roche in interactions with health authorities and support programs using novel, accelerated, or otherwise nontraditional regulatory strategies.
- Advance the external scientific standing of Genentech/Roche through high-quality publications, presentations, scientific collaborations, and participation in relevant professional or industry forums.
- Lead or provide support to inter- and intra-departmental initiatives.
Requirements
- PhD and post-doctorate or equivalent experience in toxicology or a relevant field along with a minimum of 3+ years relevant experience in the pharmaceutical/biotechnology/CRO industry related to toxicology.
- Experience in drug development demonstrating strong decision making, complex problem solving and critical data analysis and interpretation required.
- Experience in written/verbal interaction with global regulatory authorities are highly desired.
- Experience in oncology and/or non-oncology therapy areas leveraging different therapeutic modalities such as small molecules, biologics, ADCs and cell and gene therapy is highly desirable
- Demonstrate strong decision-making, complex problem solving, critical data analysis and interpretation, excellent written and verbal communication skills.
- Ability to build productive cross-functional collaborations both within and external to Genentech
- Board certification in toxicology is desirable.
Skills
- toxicology
- drug development
- decision making
- complex problem solving
- critical data analysis and interpretation
- written communication
- verbal communication
- cross-functional collaboration
- regulatory affairs
- pathology
- pharmacology
- translational science
- clinical information integration
- risk assessment
- development strategy
- GLP
- non-GLP
- new approach methodologies (NAMs)
- oncology
- small molecules
- biologics
- ADCs
- cell and gene therapy
Location
- South San Francisco, California
Work Type
- On-site presence required at least 3 days per week
- Not fully remote
Experience Level
- Principal Scientist
- entry level portfolio toxicologist
- minimum of 3+ years relevant experience
Education Level
- PhD
- post-doctorate or equivalent experience
Salary/Compensations
- $141,500 - $262,900 annual
Benefits
- Discretionary annual bonus may be available based on individual and Company performance.
- Qualifies for benefits detailed at the link provided below.
About the Company
- Translational Safety Toxicologists provide scientific leadership across drug development, from early research through clinical development and marketed products.
- Genentech is an equal opportunity employer.
Equal Opportunity
- It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence.
- The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
- If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.