Ph.D. in Toxicology, Pharmacology, or related field.
2-3 years of toxicology experience in biopharmaceutical, biotechnology, or CRO sectors.
Experience in designing and interpreting nonclinical safety studies (GLP and non-GLP).
Understanding of drug development processes and nonclinical safety's role in regulatory strategies.
Strong communication and collaboration skills with a focus on data interpretation and problem-solving.
Responsibilities
Lead nonclinical safety strategy for gene therapies in ocular and CNS programs.
Design and direct nonclinical safety and toxicology strategies to meet regulatory milestones.
Identify safety risks and conduct studies to mitigate treatment-related toxicities.
Collaborate with cross-functional teams to execute studies and interpret safety data.
Author and review nonclinical safety documentation and regulatory filings.
Communicate safety assessments to governance committees and health authorities.
Benefits
Relocation benefits available.
Discretionary annual bonus based on performance.
Comprehensive health and wellness programs.
Opportunities for professional development and training.
Full 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.
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.
Relocation benefits are available for this job posting.
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About Roche
Roche Holding AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange. The company headquarters are located in Basel. Roche is the largest pharmaceutical company in the world, and the leading provider of cancer treatments globally. The company also produces a range of diagnostic tests for medical professionals and patients. Roche was one of the first companies to bring targeted treatments to patients. In 2019, Roche had over 100,000 employees worldwide, and generated revenue of CHF 61.5 billion.
