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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.
Benefits
Relocation benefits are available for this job posting.
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Who we are
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche 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.
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