Director, Toxicology

Evommune, Inc.•Palo Alto, CA

14h•$226,000 - $280,000

About The Position

Evommune is seeking an experienced and highly motivated PhD Toxicologist to join the company as Director, Toxicology. This individual will provide toxicology strategy and executional support across Evommune’s development programs. The Director will serve as the toxicology representative on cross-functional program teams and will be responsible for the design, oversight, interpretation, and reporting of nonclinical safety studies supporting candidate selection, regulatory submissions, and clinical development. The successful candidate will bring strong scientific judgment, hands-on experience managing outsourced toxicology studies, and a solid understanding of regulatory expectations for nonclinical safety assessment. This is a highly collaborative, individual-contributor role that requires both strategic thinking and operational execution in a fast-paced biotechnology environment.

Requirements

PhD, DVM, or equivalent advanced degree in toxicology, pharmacology, pathology, immunology, or a related scientific discipline.
Typically 10 or more years of relevant experience in biotechnology, pharmaceutical development, or a related environment.
Demonstrated expertise in the nonclinical safety assessment of small molecules.
Experience designing and overseeing IND-enabling toxicology programs and supporting first-in-human clinical development.
Strong working knowledge of GLP requirements and relevant FDA, ICH, EMA, and other global regulatory guidance.
Experience preparing nonclinical sections of regulatory submissions and responding to health authority questions.
Demonstrated ability to interpret complex toxicology findings and communicate their relevance to clinical development and patient safety.
Strong experience managing CROs, consultants, study directors, and external scientific partners.
Ability to operate effectively in a lean organization and manage multiple programs and priorities simultaneously.
Excellent scientific writing, presentation, communication, and influencing skills.
Strong interpersonal skills and demonstrated success working within multidisciplinary development teams.

Nice To Haves

Experience with biologics is a plus.
Experience supporting small molecule programs.
Board certification in toxicology, such as DABT.
Experience in immunology, inflammation, dermatology, or immune-mediated diseases.
Experience supporting programs from candidate selection through early clinical development.
Experience participating in interactions with FDA or other global health authorities.
Prior experience working in a small or mid-sized biotechnology company.

Responsibilities

Develop and execute nonclinical toxicology strategies for assigned development programs.
Serve as the toxicology representative on cross-functional program teams.
Provide scientific guidance on nonclinical safety risks, study design, and program advancement.
Design, oversee, interpret, and report exploratory, IND-enabling, and clinical-stage toxicology studies.
Manage external contract research organizations, consultants, study directors, and other scientific partners.
Review and approve study protocols, amendments, data, and final reports.
Ensure studies are conducted in accordance with GLP requirements, applicable regulations, and relevant scientific guidance.
Integrate toxicology findings with pharmacology, pharmacokinetic, bioanalytical, and clinical data.
Identify potential safety risks and recommend appropriate mitigation and monitoring strategies.
Support the preparation of nonclinical sections of regulatory submissions, including pre-IND briefing packages, INDs, clinical trial applications, investigator brochures, and responses to health authority questions.
Contribute to regulatory meeting preparation and participate in health authority interactions, as appropriate.
Partner closely with colleagues in Research, DMPK, Translational Sciences, Clinical Development, Regulatory Affairs, CMC, and Program Management.
Monitor evolving scientific and regulatory expectations related to nonclinical safety assessment.
Support due diligence, portfolio evaluation, and other scientific activities as needed.