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Translational Safety Pathologists provide scientific leadership across drug development, from early research through clinical development and marketed products. This Senior Principal (SE8) role is intended for an experienced toxicologic pathologist who can immediately assume independent pathology 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 pathology, toxicology, pharmacology, translational, and clinical information to identify and contextualize risk, shape development strategy, and enable timely, high-quality decisions.

The role combines hands-on pathologic evaluation with broad drug-development pathology leadership. The Senior Principal Pathologist-Scientist is expected to operate with a high degree of autonomy, influence cross-functional teams and senior decision makers, and contribute visibly to the scientific and strategic direction of Translational Safety Pathology.

Opportunity:

As an integral member of our dynamic team, you will:

• Serve as lead/project pathologist for multiple complex development programs and provide independent pathology strategy from discovery and candidate selection through regulatory milestones and later-stage development, as needed.

• Provide expert veterinary, clinical, technical, and scientific input for studies, including necropsy, clinical pathology and histopathology interpretation, pathology peer review, and integrated assessment of study findings.

• Partner closely with toxicologists, 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 best-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 to resolve uncertainty and inform development strategy.

• Contribute to and, where appropriate, lead the development of safety biomarkers, diagnostics, digital/computational pathology approaches, and 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 or critically review 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.

• Provide proactive, high-impact scientific and strategic pathology leadership beyond assigned programs, including leadership of cross-functional initiatives, therapeutic-area or expert working groups, and functional capability-building efforts.

• Mentor pathologists and other scientists, promote rigorous and pragmatic scientific decision making, and contribute to an inclusive, collaborative, high-performing team culture.

• Advance the external scientific standing of Genentech/Roche through high-quality publications, presentations, scientific collaborations, and participation in relevant professional or industry forums.

Who You Are:

• DVM/VMD or equivalent veterinary degree and board certification by the American College of Veterinary Pathology (ACVP), European College of Veterinary Pathologists (ECVP), or equivalent recognized board with 5+ years of direct drug-development experience in the pharmaceutical or biotechnology industry, with sufficient breadth and depth to independently support active programs from the time of hire.

• Demonstrated ability to independently support and influence drug-development programs as a toxicologic pathologist, including interpretation of nonclinical safety data in a broader translational and regulatory context.

• A track record of effective cross-functional leadership and sound, risk-based decision making in situations with ambiguity, incomplete data, compressed timelines, or competing program priorities.

• Strong knowledge of toxicologic pathology, nonclinical safety assessment, and the principles that underpin regulatory toxicology and drug-development strategy.

• Recognized expertise and a demonstrated record of scientific leadership in at least one area relevant to translational safety, toxicologic pathology, or drug development.

• Excellent written and verbal communication skills, including the ability to communicate complex pathology and safety issues clearly to project teams, senior leaders, and regulatory audiences.

• Ability and willingness to work on-site in South San Francisco at least 3 days per week.

Preferred Qualifications and Experience

• PhD or equivalent advanced research training/experience in pathology or a related biomedical discipline.

• Experience with, or strong scientific interest in, novel therapeutic modalities and the unique safety-assessment challenges they create.

• Experience developing or applying NAMs, organotypic/in vitro models, computational or digital pathology approaches, or other innovative tools that improve human relevance and/or reduce animal use.

• Demonstrated commitment to animal welfare and the 3Rs (replacement, reduction, and refinement) in nonclinical development.

• Drug-development experience working across therapeutic areas/ disease indications.

• 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.

Please note: This is not a fully remote position. Regular on-site presence in South San Francisco is an essential expectation of the role.

Relocation benefits are not available for this posting.

The expected salary range for this position based on the primary location of California is $198,900- $369,300.  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.