Associate Director, Toxicology

Protagonist Therapeutics•Newark, NJ

About The Position

Protagonist Therapeutics is seeking a talented, highly motivated professional to join the Toxicology, Nonclinical Development team as Associate Director Toxicology, Nonclinical Development (Program Toxicologist). This role will lead and manage CRO and consultant activities that support drug research and development across the PTGX pipeline. The successful candidate will be responsible for developing nonclinical toxicology strategies, overseeing GLP and non-GLP studies, preparing toxicology components of regulatory submissions, and responding to inquiries from regulatory authorities.

Requirements

PhD or DVM in biological sciences, toxicology, pharmacology, or a related discipline.
Minimum of 5–10 years of relevant drug development experience, preferably in the biotechnology or pharmaceutical industry.
Demonstrated experience developing and executing nonclinical toxicology strategies that support IND-enabling studies, first-in-human clinical trials, and later-stage development programs.
Strong working knowledge of Good Laboratory Practice regulations and relevant FDA, ICH, OECD, EMA, and other global nonclinical safety guidelines.
Experience in preclinical development, toxicology, nonclinical pharmacology, drug metabolism, pharmacokinetics, and toxicokinetics.
Proven ability to manage CROs, consultants, and external academic or industry collaborators, including oversight of study design, budgets, timelines, monitoring, data review, and final reports.
Broad and integrated understanding of pharmacology, toxicology, DMPK, safety pharmacology, pathology, and translational safety assessment.
Excellent verbal and written communication skills, with the ability to build strong working relationships with internal colleagues, cross-functional teams, external vendors, and consultants.
Strong scientific background, preferably demonstrated through peer-reviewed publications, regulatory writing experience, or presentations in relevant medical and life science forums.
Excellent decision-making, complex problem-solving, critical thinking, data analysis, and data interpretation skills.
Highly motivated, flexible, and proactive self-starter who takes ownership of new tasks and delivers high-quality results with limited supervision.
Demonstrated ability to be productive and successful in a fast-paced, matrixed, and multi-tasking work environment.

Nice To Haves

DABT board certification is preferred.

Responsibilities

Serve as a self-directed toxicology leader and key member of a dynamic team supporting PTGX drug discovery and development programs.
Independently develop phase-appropriate nonclinical toxicology strategies for PTGX pipeline molecules and represent toxicology on cross-functional project teams.
Design, revise, and finalize nonclinical toxicology study protocols, study designs, data analyses, and reports, including plans that support first-in-human and later-stage clinical development.
Prepare and critically review nonclinical toxicology sections for IND, CTA, NDA, and other regulatory submissions, ensuring alignment with applicable US and ex-US regulatory expectations.
Identify, evaluate, and resolve program-specific toxicology issues in collaboration with the supervisor, project teams, CROs, consultants, and other subject-matter experts.
Critically review and edit CRO nonclinical toxicology and related study reports, including pharmacology, ADME, PK/TK, safety pharmacology, and pathology reports; analyze and interpret data; and coordinate report finalization.
Ensure study documentation and regulatory deliverables are scientifically sound, timely, and consistent with global regulatory and compliance requirements.
Manage and monitor GLP and non-GLP nonclinical studies conducted at CROs in accordance with PTGX vendor management SOPs and policies, ensuring quality, timelines, and regulatory compliance are met or exceeded.
Provide clear analysis, interpretation, and visualization of nonclinical toxicology and related data for internal communications, program team presentations, regulatory interactions, and decision-making.
Maintain current knowledge of relevant scientific literature, methodologies, regulatory guidance, and emerging best practices applicable to PTGX pipeline products and nonclinical development programs.