Project Toxicologist

Genentech; Philadelphia (Philadelphia County); On-site; USD 105,000 - 195,000; Full time

Benefits offered by this job

Relocation benefits

Job summary

Genentech is seeking a Regulatory/Project Toxicologist to lead the nonclinical safety strategy for gene therapy programs, from discovery through late-stage development. You will champion safety evaluation for ocular- and CNS-directed therapies and collaborate with multidisciplinary teams to accelerate medicines to patients.

This role requires a Ph.D. with 2–3 years of toxicology experience, strong regulatory acumen, and exceptional communication to drive decisions across discovery, preclinical,

Qualifications

• Ph.D. in Toxicology, Pharmacology, or a closely related scientific discipline.
• 2–3 years of relevant toxicology experience in biopharmaceutical/biotech/CRO settings.
• Demonstrated ability to design, execute, and interpret robust nonclinical safety studies (GLP and non-GLP).
• Strong working knowledge of drug development processes and the nonclinical safety role in regulatory and early clinical strategies.
• Exceptional communication and cross-functional leadership skills.

Responsibilities

• Lead nonclinical safety strategy and serve as the primary toxicology representative on cross-functional drug development teams.
• Design and direct integrated nonclinical safety and toxicology strategies to support progression and regulatory milestones.
• Lead proactive safety risk identification and investigative mechanistic studies to mitigate toxicities.
• Collaborate with Research, Clinical, Regulatory, CMC, and CROs for study execution and data interpretation.
• Author and review nonclinical safety documentation and regulatory submissions (INDs, CTAs, PIPs, BLAs).
• Communicate safety findings to governance committees and health authorities.

Skills

Exceptional communication

Cross-functional leadership

Collaboration

Education

Ph.D. in Toxicology/Pharmacology or related

Job description

The Position

The Opportunity

As a Regulatory/Project Toxicologist within our Department of Pharmacology and Toxicology, you will spearhead the nonclinical safety strategy for Roche innovative genetic medicine portfolio. In this role, you will champion the safety evaluation of cutting-edge gene therapies—focusing on ocular- and CNS-directed programs—from early discovery through late-stage clinical development. You will collaborate with world-class multidisciplinary scientists, driving decisions that safely accelerate groundbreaking medicines to patients.

• Serve as the nonclinical safety lead and primary toxicology representative on cross-functional drug development project teams across discovery, pre-clinical, and clinical stages.
• Formulate, design, and direct integrated nonclinical safety and toxicology strategies (GLP and non-GLP) to support program progression and key regulatory milestones.
• Lead proactive safety risk identification and design investigative mechanistic studies to evaluate and mitigate treatment-related toxicities.
• Partner cross-functionally with Research Leads, Clinical, Regulatory, CMC, and external CROs to coordinate study execution, review protocols, and interpret complex safety data.
• Author and review comprehensive nonclinical safety documentation, high-level regulatory filings (e.g., INDs, CTAs, PIPs, BLAs, GMO applications), and clinical documents (Investigator Brochures, ICFs).
• Communicate scientific findings and safety risk assessments clearly to internal governance committees and represent the organization in meetings with global health authorities.

Who You Are:

• You hold a Ph.D. in Toxicology, Pharmacology, or a closely related scientific discipline.
• You bring a minimum of 2–3 years of relevant toxicology experience within the biopharmaceutical, biotechnology, or contract research (CRO) industry.
• You possess demonstrated experience in designing, executing, and interpreting robust nonclinical safety studies (GLP and non-GLP) that drive scientific and portfolio decisions.
• You demonstrate a working understanding of drug development processes and the role of nonclinical safety in guiding regulatory and early clinical strategies.
• You are an exceptional communicator and collaborator, recognized for critical data interpretation, complex scientific problem-solving, and cross-functional leadership.

Preferred

• Direct experience with genetic medicines, viral vectors (particularly AAVs), gene editing platforms, or novel RNA/oligonucleotide modalities.
• Prior experience with ocular- or central nervous system (CNS)-targeted drug delivery or therapeutic development.
• Demonstrated track record of authoring nonclinical regulatory modules for global health authority dossiers (IND/CTA) and participating in health authority interactions.
• Proven ability to manage multiple complex safety programs simultaneously while driving collaborative relationships with CRO partners and academic collaborators.

The expected salary range for this position based on the primary location of Philadelphia is $104,900 to $194,900 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

Relocation benefits are available for this job posting.

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.