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Manager Director Toxicology Jobs (NOW HIRING)

Immunome, Inc.

Director, Toxicology

Bothell, WA · On-site

Position Overview The Director, Toxicology provides scientific and strategic leadership for the non ... Manage CRO performance, timelines, budgets, and scientific deliverables. Cross-Functional ...

Tarsus Pharmaceuticals

Director, Toxicology

Irvine, CA · On-site +1

About the Role The Director, Toxicology Translational Science will serve as a scientific and ... Experience managing outsourced studies; thrives in fast-paced environments. * Excellent oral and ...

Immunome, Inc.

Director, Toxicology

Bothell, WA

Position Overview The Director, Toxicology provides scientific and strategic leadership for the non ... Manage CRO performance, timelines, budgets, and scientific deliverables. Cross-Functional ...

Evommune, Inc.

Director, Toxicology

Palo Alto, CA · On-site

Manage external contract research organizations, consultants, study directors, and other scientific ... Integrate toxicology findings with pharmacology, pharmacokinetic, bioanalytical, and clinical data.

Inotivco

Director, Toxicology

Gaithersburg, MD · On-site

$120.20 - $175K/hr

As a group manager the Director will be responsible for reviewing protocols, SOPs, data, and ... General Toxicology. * Recognizes potential training needs in preparation for new business ...

BASI GAITHERSBURG LLC

Director, Toxicology

Gaithersburg, MD · On-site

$120.20 - $175/hr

Director of Toxicology The Director of Toxicology is the scientific leader for the site and serves as a mentor and manager for a group of Study Directors overseeing general toxicology and safety ...

Inotiv

Director, Toxicology

Gaithersburg, MD · On-site

$120.20 - $175K/hr

As a group manager the Director will be responsible for reviewing protocols, SOPs, data, and ... General Toxicology. * Recognizes potential training needs in preparation for new business ...

Tarsus Pharmaceuticals

Director, Toxicology

Irvine, CA · On-site

About the Role The Director, Toxicology Translational Science will serve as a scientific and ... Experience managing outsourced studies; thrives in fast-paced environments. * Excellent oral and ...

OnKure Therapeutics

Senior Director, Toxicology

Boulder, CO · On-site

$280K - $300K/yr

The Senior Director of Toxicology provides strategic and scientific leadership for all nonclinical ... Manage toxicology budgets and timelines across multiple programs * Partner with discovery, clinical ...

Vir Biotechnology

Director, Toxicology

San Francisco, CA · On-site

$203K - $284K/yr

THE OPPORTUNITY Vir Biotechnology is seeking an experienced Director, Toxicology to lead non ... cycle management * Oversee nonclinical safety studies (GLP and non-GLP) in compliance with ...

Menlo Ventures

Director, Toxicology

South San Francisco, CA · On-site

$232 - $256/hr

Description The Director of Toxicology is a strategic and hands‑on scientific leader responsible ... Management * Analyzes, interprets, summarizes, and presents nonclinical safety data to internal ...

Calibr

SENIOR DIRECTOR, TOXICOLOGY

San Diego, CA · On-site

The Senior Director of Toxicology will be the primary toxicology expert across our pipeline ... Oversee and manage multiple contract research organizations (CROs) supporting outsourced toxicology ...

Evommune, Inc.

Director, Toxicology

Palo Alto, CA · On-site

$226 - $280/hr

Manage external contract research organizations, consultants, study directors, and other scientific ... Integrate toxicology findings with pharmacology, pharmacokinetic, bioanalytical, and clinical data.

Ionis

Associate Director, Toxicology

Carlsbad, CA · On-site

Manage outsourced toxicology studies at CROs, including study design, protocol and report review ... direct authority across scientific and functional teams * Proven ability to convey advanced ...

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Infographic showing various Manager Director Toxicology job openings in the United States as of August 2026, with employment types broken down into 88% Full Time, 11% Part Time, and 1% Contract. Highlights an 81% Physical, 2% Hybrid, and 17% Remote job distribution.

Associate Director, Toxicology

Protagonist Therapeutics

Newark, CA

$185K - $205K/yr

Full-time

Re-posted 8 days ago

Job description

Associate Director, Toxicology, Nonclinical Development (Program Toxicologist)
Position Description:
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. This position will report to the Senior Vice President, Toxicology, Nonclinical Development.
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.
Qualifications:
  • PhD or DVM in biological sciences, toxicology, pharmacology, or a related discipline.
  • DABT board certification is preferred.
  • 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.
The base pay range for this position at commencement of employment is expected to be between $185K and $205K / 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. The Company's proprietary peptide technology platform enables de novo discovery of peptide therapeutics. Two novel peptides derived from Protagonist's proprietary discovery platform are at or near commercialization. ICOTYDE™ (icotrokinra) is approved in the U.S. for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy. ICOTYDE is the first and only targeted oral peptide that precisely blocks the Interleukin-23 receptor (IL-23R) licensed to Janssen Biotech, Inc.,a Johnson amp; Johnson company. ICOTYDE was jointly discovered by Protagonist and Johnson amp; Johnson scientists, with Protagonist having primary responsibility for the development of ICOTYDE through Phase 1, and Johnson amp; Johnson assuming responsibility for further development and commercialization. An NDA for rusfertide, a first-in-class hepcidin mimetic peptide that is being co-developed with Takeda Pharmaceuticals pursuant to a worldwide license and collaboration agreement entered in 2024, is under priority review with the FDA. Protagonist holds an option to co-commercialize rusfertide in the U.S. through a 50/50 profit and loss share structure or can opt-out of this structure. The Company also has a number of preclinical stage drug discovery programs addressing clinically and commercially validated targets including an oral IL-17 peptide antagonist, obesity dual and triple agonists, an oral hepcidin functional mimetic, and the recently announced IL-4 and amylin programs.
More information on Protagonist, its pipeline drug candidates, and clinical studies can be found on the Company's website at https://www.protagonist-inc.com.

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