Senior Principal Scientist, Pathologist
Roche
Summary
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.
Job description
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.
Requirements
- DVM/VMD or equivalent veterinary degree
- Board certification by ACVP, ECVP, or equivalent recognized board
- 5+ years of direct drug-development experience in pharmaceutical or biotechnology industry
- Demonstrated ability to independently support and influence drug-development programs as a toxicologic pathologist
- Track record of effective cross-functional leadership and risk-based decision making
- Strong knowledge of toxicologic pathology, nonclinical safety assessment, and regulatory toxicology
- Recognized expertise and record of scientific leadership in translational safety, toxicologic pathology, or drug development
- Excellent written and verbal communication skills
- Ability and willingness to work on-site in South San Francisco at least 3 days per week
Benefits
- Annual bonus
- Health insurance
- Disability accommodation
Company overview
Roche is a Swiss multinational healthcare company and a global pioneer in pharmaceuticals and diagnostics, founded in 1896 and headquartered in Basel, Switzerland. As the world's largest biotech company and the fifth-largest pharmaceutical company by revenue, Roche operates through two primary divisions: Pharmaceuticals and Diagnostics. The company is renowned for its leadership in personalized healthcare, combining strengths in both drug development and diagnostic testing to deliver tailored treatments for patients. Roche maintains a strong focus on oncology, immunology, infectious diseases, ophthalmology, and central nervous system disorders, with a portfolio that includes over 30 medicines on the World Health Organization's Model Lists of Essential Medicines. The company owns significant subsidiaries including Genentech, Chugai Pharmaceuticals, Ventana Medical Systems, and Foundation Medicine. With approximately 103,000 employees worldwide and operations in over 100 countries, Roche has established itself as a leader in cancer treatments globally while maintaining a robust pipeline of innovative therapies and diagnostic solutions. The company's commitment to sustainability has been recognized through ten consecutive years as Group Leader in the Dow Jones Sustainability Indices within the Pharmaceuticals, Biotechnology & Life Sciences Industry.