Translational Safety Toxicologists provide scientific leadership across drug development, from early research through clinical development and marketed products. This Senior Principal Scientist role is intended for an experienced portfolio toxicologist who can immediately assume independent 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 Senior 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 lead toxicologist for multiple complex development programs across therapeutic areas and modalities and contribute to overall program development on interdisciplinary project team
- Provide scientific leadership in the design and implementation of 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.
- Proactively manage potential safety liabilities and communicate 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.
- Provide proactive, high-impact scientific and strategic toxicology leadership beyond assigned programs, including leadership of cross-functional initiatives, therapeutic-area or expert working groups, and functional capability-building efforts.
- Mentor toxicologists and other scientists, promote rigorous and pragmatic scientific decision making, and contribute to an inclusive, collaborative, high-performing team culture.
- Lead or provide support to inter- and intra-departmental initiatives.
Who You Are
Senior Principal Scientist
- PhD and post-doctorate or equivalent experience in toxicology or a relevant field along with a minimum of 8+ years relevant experience in the pharmaceutical/biotechnology/CRO industry related to toxicology.
- Extensive experience in drug development demonstrating strong decision making, complex problem solving and critical data analysis and interpretation required.
- Extensive experience in drug development and written/verbal interactions with global regulatory authorities are required.
- Extensive experience in small molecules, degraders, and ADCs across multiple therapeutic areas is highly desirable.
- Experience in de-risking metabolites and impurities highly desirable
- Experience with, or strong scientific interest in, novel therapeutic modalities and the unique safety-assessment challenges they create.
- Proven track record of demonstrating ability to independently support and influence drug-development programs as a toxicologist, including interpretation of nonclinical safety data in a broader translational and regulatory context
- Consistent track record of demonstrating strong decision-making, complex problem solving, critical data analysis and interpretation, excellent written and verbal communication skills.
- Ability to build and lead productive cross-functional collaborations both within and external to Genentech
- Recognized expertise and a demonstrated record of scientific leadership in at least one area relevant to translational safety, toxicology, or drug development.
- Excellent written and verbal communication skills, including the ability to communicate complex toxicology and safety issues clearly to project teams, senior leaders, and regulatory audiences.
- Direct experience with health-authority interactions, novel development pathways, or regulatory strategies that require a high degree of scientific judgment and integration.
- Evidence of scientific thought leadership through influential internal contributions, publications, presentations, professional society activity, or other recognized contributions to the field.
- Board certification in toxicology is desirable.
Location
South San Francisco, California
This is not a fully remote position. Regular on-site presence in South San Francisco is an essential expectation of the role. On-site presence required at least 3 days per week.
Relocation benefits are available for this position.
The expected salary range for this position based on the primary location of California is $173,100 and $321,500 annual. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Benefits
Genentech is an equal opportunity employer. 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.
