Associate Director of Toxicology, Nonclinical Development (Program Toxicologist)

Associate Director of Toxicology, Nonclinical Development (Program Toxicologist)

Position Description:

Protagonist Therapeutics is seeking a talented and highly motivated professional to join the Toxicology, Nonclinical Development group as the Associate Director of Toxicology, Nonclinical Development (Program toxicologist). This position will direct and manage the CRO and consultant activities to support drug research and development across all the PTGX pipelines, and is responsible for the preparation of nonclinical toxicology components of regulatory submissions for PTGX portfolio of products in support of IND, NDA and other regulatory submission packages and respond to inquiries from regulatory authorities. This position will report to the Senior VP of Toxicology, Nonclinical Development.

Responsibilities:

• The individual is a self-starter with excellent management and communication capabilities and is a critical part of a highly dynamic team that to support the PTGXs drug development process
• Independently develop nonclinical toxicology testing strategy for PTGXs pipeline molecules. Actively participate and represent toxicology at cross-functional project teams
• Conceptualize, develop, revise, and finalize nonclinical toxicology study designs, data analyses, reports and nonclinical sections for IND first-in-human submissions, as well as required other regulatory submissions to ensure US and ex-US compliance
• Critically review and edit CRO nonclinical toxicology and other related (pharmacology, ADME, PK/TK, ADA) study reports, analyze and interpret data and coordinate report finalization
• Comprehend project toxicology concerns and manage and resolve any problems relevant to toxicology and related fields after timely consultation with the supervisor and project team
• Ensure documentation consistent with global (US and ex-US) regulatory and compliance requirements
• Manage and monitor nonclinical studies (GLP and non-GLP) at the CROs per PTGX vendor management SOPs and policies and ensure regulatory/compliance requirements are met or exceeded
• Provide analysis, interpretation, and visualization of nonclinical toxicology and other related data and results in preparation for internal corporate communication and program team presentation
• Maintain a current understanding of relevant literature and methodology, as well as the scientific literature related to the specific PTGX pipeline products and research and development pipelines

Qualifications:

• PhD or DVM in Biological Sciences/ Toxicology/Pharmacology or related fields
• DABT board certification preferred
• Minimum 5-10 years of drug development experience
• Demonstrated ability to identify key information sources and integrate data from multiple sources into a rationale understanding of toxicology
• Knowledge of US FDA Good Laboratory Practice (GLP) Regulations and US FDA/ICH/OECD guidelines
• Experience in a research field related to preclinical development, toxicology, and preclinical pharmacology and drug metabolism
• Experience in management of CROs and external industrial and/or academic collaborators
• Broad and integrated understanding and knowledge of pharmacology, toxicology and DMPK
• Strong verbal and written communication skills in order to build and maintain strong collaborations with internal co-workers and external vendors and consultants
• Good scientific background as demonstrated through publications in basic medical and life science journals
• Strong decision-making, complex problem-solving and critical data analysis and interpretation skills
• Self-starter who is highly motivated and flexible in taking on new tasks
• Productive and successful in an intense, matrix, and multi-tasked working environment

The base pay range for this position at commencement of employment is expected to be between $165,000 and $190,000/ year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.

Protagonist Therapeutics is a discovery through late-stage development biopharmaceutical company. Two novel peptides, icotrokinra and rusfertide, derived from Protagonist's proprietary discovery platform are currently in advanced Phase 3 clinical development, with New Drug Application submissions to the FDA expected in 2025. Icotrokinra (JNJ-2113) is a first-in-class investigational targeted oral peptide that selectively blocks the Interleukin-23 receptor ("IL-23R") which is licensed to Janssen Biotech, Inc., a Johnson & Johnson company. Following icotrokinra's joint discovery by Protagonist and Johnson & Johnson scientists pursuant to the companies' IL-23R collaboration, Protagonist was primarily responsible for development of icotrokinra through Phase 1, with Johnson & Johnson assuming responsibility for development in Phase 2 and beyond. Rusfertide, a mimetic of the natural hormone hepcidin, is currently in Phase 3 development for the rare blood disorder polycythemia vera (PV). Rusfertide is being co-developed and will be co-commercialized with Takeda Pharmaceuticals pursuant to a worldwide collaboration and license agreement entered into in 2024 under which the Company remains primarily responsible for development through NDA filing. The Company also has a number of pre-clinical stage oral drug discovery programs addressing clinically and commercially validated targets, including the IL-17 oral peptide antagonist PN-881, an oral hepcidin program, and an oral obesity program.