Project Toxicologist

Genentech • Philadelphia, PA

3d • $104,900 - $194,900

About The Position

As a Regulatory/Project Toxicologist in the Department of Pharmacology and Toxicology, you will lead nonclinical safety strategy for Roche’s genetic medicine portfolio. You will champion the safety evaluation of gene therapies, with a focus on ocular- and CNS-directed programs, from early discovery through late-stage clinical development. You will collaborate with multidisciplinary scientists to help safely advance medicines to patients.

The role serves as the nonclinical safety lead and primary toxicology representative on cross-functional drug development teams. It involves designing and directing integrated GLP and non-GLP safety strategies, identifying and mitigating safety risks, coordinating studies with internal partners and external CROs, and authoring or reviewing nonclinical and clinical regulatory documents. You will communicate findings to governance committees and represent the organization in discussions with global health authorities.

Requirements

• Ph.D. in Toxicology, Pharmacology, or a closely related scientific discipline.
• At least 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 that inform scientific and portfolio decisions.
• Working understanding of drug development processes and the role of nonclinical safety in regulatory and early clinical strategies.
• Strong communication and collaboration skills, 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 authoring nonclinical regulatory modules for global health authority dossiers, including INDs and CTAs, 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 spanning 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.
• Work with Research Leads, Clinical, Regulatory, CMC, and external CROs to coordinate study execution, review protocols, and interpret complex 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 company benefits detailed at a linked benefits page; specific benefits are not listed in the posting.

What This Job Offers

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