Project Toxicologist

F. Hoffmann-La Roche AG; Pennsylvania; Vor Ort; USD 150.000 - 195.000; Vollzeit

Benefits dieser Stelle

Relocation benefits

Discretionary annual bonus

Zusammenfassung

Roche is seeking a Regulatory/Project Toxicologist within our Department of Pharmacology and Toxicology to lead the nonclinical safety for our genetic medicine portfolio, focusing on ocular- and CNS-directed programs from discovery through late-stage development.

You will partner with researchers, clinical, regulatory, CMC, and CROs to design studies, author safety documentation, and drive regulatory milestones while communicating risk assessments to governance committees and health authorities.

Qualifikationen

• Ph.D. in Toxicology, Pharmacology, or a closely related scientific discipline.
• Minimum 2–3 years of relevant toxicology experience in biopharma, biotech, or CRO.
• Experience designing, executing, and interpreting nonclinical safety studies (GLP and non-GLP).

Aufgaben

• Lead nonclinical safety strategy for Roche genetic medicine portfolio.
• Design and direct integrated nonclinical safety and toxicology programs.
• Coordinate study execution with CROs and internal teams; review protocols and data.
• Author regulatory submissions and clinical documents; communicate risks to governance.

Kenntnisse

Cross-functional leadership

GLP/non-GLP safety studies

Scientific communication

Ausbildung

Ph.D. in Toxicology or Pharmacology

Jobbeschreibung

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

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.

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Benefits

Relocation benefits are available for this job posting.

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. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.