Senior Toxicology Program Leader, Nonclinical Development

Protagonist Therapeutics Inc.; Newark (CA); On-site; USD 185,000 - 205,000; Full time

Job summary

Protagonist Therapeutics Inc. in Newark, CA is seeking an Associate Director Toxicology, Nonclinical Development to lead and manage CROs and consultants across the PTGX pipeline.

You will develop nonclinical toxicology strategies, oversee GLP and non-GLP studies, and prepare toxicology components of regulatory submissions, reporting to the Senior Vice President, Toxicology, Nonclinical Development. The successful candidate will oversee cross-functional teams, ensure regulatory alignment, and

Qualifications

• PhD or DVM in biological sciences, toxicology, pharmacology, or a related discipline.
• DABT board certification preferred.
• 5–10+ years in drug development, biotech or pharmaceutical industries.
• Experience developing nonclinical toxicology strategies for IND-enabling studies.
• Strong knowledge of FDA, ICH, OECD, EMA safety guidelines.
• Experience managing CROs, consultants, and external collaborators.
• Excellent written and verbal communication; cross-functional collaboration.
• Adaptability to fast-paced, matrixed environments.

Responsibilities

• Lead nonclinical toxicology strategies for PTGX pipeline across development stages.
• Oversee GLP and non-GLP studies with CROs and consultants.
• Prepare toxicology sections for IND, CTA, NDA submissions.
• Review study reports and ensure regulatory compliance.
• Provide data interpretation and communication for teams and regulators.
• Stay updated on regulatory guidance and best practices.

Skills

CRO management

Regulatory writing

Nonclinical toxicology

Data analysis

Program leadership

Communication

Team collaboration

Education

PhD or DVM

DABT certification

Job description

Protagonist Therapeutics Inc. in Newark, CA is seeking an Associate Director Toxicology, Nonclinical Development to lead and manage CROs and consultants across the PTGX pipeline.

You will develop nonclinical toxicology strategies, oversee GLP and non-GLP studies, and prepare toxicology components of regulatory submissions, reporting to the Senior Vice President, Toxicology, Nonclinical Development. The successful candidate will oversee cross-functional teams, ensure regulatory alignment, and