Project Toxicologist

Genentech • Philadelphia, PA

1d

About The Position

As a Regulatory/Project Toxicologist in the Department of Pharmacology and Toxicology, the employee will lead nonclinical safety strategy for Roche’s genetic medicine portfolio, focusing on ocular- and CNS-directed gene therapies from early discovery through late-stage clinical development. The role serves as the nonclinical safety lead and primary toxicology representative on cross-functional drug development teams across discovery, preclinical, and clinical stages. It involves designing and directing integrated GLP and non-GLP safety strategies, identifying safety risks, commissioning mechanistic studies, coordinating work with internal partners and external CROs, authoring and reviewing regulatory and clinical documents, communicating findings to internal governance committees, and representing the organization in discussions with global health authorities.

Requirements

• Ph.D. in Toxicology, Pharmacology, or a closely related scientific discipline.
• Minimum of 2–3 years of relevant toxicology experience in the biopharmaceutical, biotechnology, or contract research industry.
• Demonstrated experience designing, executing, and interpreting robust GLP and non-GLP nonclinical safety studies.
• Working understanding of drug development processes and the role of nonclinical safety in regulatory and early clinical strategies.
• Strong communication and collaboration skills, including 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.
• Experience with ocular- or CNS-targeted drug delivery or therapeutic development.
• Track record of authoring nonclinical regulatory modules for global health authority dossiers (IND/CTA) and participating in health authority interactions.
• Ability to manage multiple complex safety programs simultaneously and build collaborative relationships with CRO partners and academic collaborators.

Responsibilities

• Serve as the nonclinical safety lead and primary toxicology representative on cross-functional drug development teams across discovery, preclinical, and clinical stages.
• Formulate, design, and direct integrated GLP and non-GLP nonclinical safety and toxicology strategies to support program progression and regulatory milestones.
• Identify safety risks proactively and design mechanistic studies to evaluate and mitigate treatment-related toxicities.
• Partner with Research Leads, Clinical, Regulatory, CMC, and external CROs to coordinate study execution, review protocols, and interpret safety data.
• Author and review nonclinical safety documentation, regulatory filings such as INDs, CTAs, PIPs, BLAs, and GMO applications, and clinical documents such as Investigator Brochures and ICFs.
• Communicate scientific findings and safety risk assessments to internal governance committees.
• Represent the organization in meetings with global health authorities.

Benefits

• Relocation benefits are available.
• A discretionary annual bonus may be available based on individual and Company performance.
• The position qualifies for benefits detailed at the link provided in the posting.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree