Translational Safety Toxicologists provide scientific leadership across drug development, from early research through clinical development and marketed products. This Principal Scientist role is intended for an entry level portfolio toxicologist who can assume toxicology and safety leadership for multiple fast-moving development programs, including programs involving novel modalities and novel, accelerated, or otherwise nontraditional regulatory strategies. The successful candidate will integrate toxicology, pathology, pharmacology, translational, and clinical information to identify and contextualize risk, shape development strategy, and enable timely, high-quality decisions.
Working in a collaborative team environment, the Principal Scientist leads the safety assessment of Genentech therapeutics by creating a best weight-of-evidence synthesis of existing knowledge and comprehensive investigations of toxicologic activity, strategic planning, and designing/implementing/supervising toxicology studies in support of program advancement. The role combines toxicological evaluation and contributes visibly to the scientific and strategic direction of cross-functional portfolio development teams, the broader toxicology leadership, and senior decision makers.
The Opportunity
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.
Who You Are
Principal Scientist
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,…