Project Toxicologist

F. Hoffmann-La Roche AG; Philadelphia (Philadelphia County); On-site; USD 150,000 - 195,000; Full time

Benefits offered by this job

Relocation benefits

Discretionary annual bonus

Job summary

Roche seeks a Regulatory/Project Toxicologist to lead nonclinical safety strategy for gene-therapy programs from discovery to late-stage development. You will work with multidisciplinary scientists to accelerate safe, patient-ready medicines.

You will serve as the nonclinical safety lead on cross-functional teams, design safety studies, coordinate CROs, and author regulatory documents, communicating findings to governance and health authorities.

Qualifications

• Ph.D. in Toxicology, Pharmacology, or a closely related scientific discipline.
• 2–3 years of experience in toxicology within biopharma, biotech, or CROs.
• Experience designing and interpreting nonclinical safety studies (GLP and non-GLP).
• Understanding of drug development and the role of nonclinical safety in regulatory and early clinical strategy.
• Excellent communication and cross-functional leadership skills.

Responsibilities

• Serve as the nonclinical safety lead on cross-functional drug development teams.
• Design, implement, and interpret integrated nonclinical safety strategies (GLP and non-GLP).
• Coordinate study execution with CROs and internal leads; review protocols.
• Author and review nonclinical safety documentation and regulatory submissions.
• Communicate findings and risk assessments to governance and health authorities.

Skills

Nonclinical safety design

GLP studies

Toxicology data interpretation

Cross-functional collaboration

Regulatory documentation

Education

Ph.D. in Toxicology or Pharmacology

Job description

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.### ### 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 $149,900 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. BenefitsRelocation benefits are available for this job posting.