Project Toxicologist

Roche•Philadelphia, PA

6d•Onsite

About The Position

As a Regulatory/Project Toxicologist within Roche's Department of Pharmacology and Toxicology, you will spearhead the nonclinical safety strategy for Roche's 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.

Requirements

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

Nice To Haves

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.

Responsibilities

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.