Job Description

Job Title: Associate Director of Toxicology

Department: R&D

Location: On Site / Hybrid

About SiteOne Therapeutics

SiteOne Therapeutics is a clinical-stage biopharmaceutical company advancing a novel class of highly selective small molecule inhibitors targeting NaV1.7, NaV1.8, and other ion channels to treat pain, cough and other conditions involving hyperexcitability of the peripheral nervous system. Since its inception, SiteOne has been dedicated to the development of safe and effective pain therapeutics without the significant addiction potential and side effects of opioids. The company is also advancing additional novel drug candidates that exhibit precise selectivity for individual ion channel subtypes to treat other sensory hyperexcitability disorders such as chronic cough and chronic ocular surface pain.

Position Summary

The Associate Director of Toxicology, you support and advance innovative drug discovery and development programs by providing expert guidance and hands-on toxicology and safety pharmacology support. You will apply your deep toxicology knowledge and industry experience to design and manage non-clinical safety studies, provide strategic input to project teams, with the highest standards of scientific and ethical conduct. You will work with cross-functional teams, collaborating closely Discovery Biology, Pharmacology, Medicinal Chemistry, DMPK, CMC and Clinical to drive our programs forward.

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Responsibilities

• Apply your toxicology expertise to design, manage, analyze, interpret, and report on safety pharmacology and toxicology studies, including general toxicology, genetic toxicology, developmental & reproductive toxicology, as well as toxicokinetics.
• Draft, review and approve toxicology study protocols, reports, associated nonclinical summaries, regulatory submission sections and associated documentation, as well as abstracts/manuscripts for publication.
• Provide strategic toxicological assessments and preclinical guidance to project teams and senior management to inform key program decisions and clinical/regulatory strategies.
• Oversee contracts, budgets and CRO relationships for outsourced toxicology/safety pharmacology studies to ensure the highest standards of scientific and ethical conduct.
• Maintain up-to-date toxicology plans for all IND and NDA enabling projects/programs including listings of studies, timelines, status, and costs; update and refine as necessary.
• Assess the risk of drug candidates on reproductive health, particularly in relation to exposure levels and durations.
• Leverage your regulatory expertise to provide high-quality, submission-ready documentation for interactions with health authorities.

Education & Experience Requirements

Education:

• PhD in Toxicology with 8-10 years industry experience in regulatory toxicology.

Background and Experience:

• Extensive hands-on experience in all facets of toxicology study conduct with a proven track record of conducting preclinical drug safety assessments; an emphasis on developmental and reproductive toxicology is a plus.
• Experience in outsourcing and external oversight of nonclinical toxicology studies conducted by qualified CROs.
• Deep knowledge of global regulatory requirements for non-clinical safety packages across all phases of development; Experience in working with U.S. and European regulatory authorities.
• Excellent communication skills to present complex scientific information to diverse audiences and author regulatory documents and scientific publications.
• Ability to make risk assessments and represent toxicology perspectives on project teams and with external partners.
• Excellent communication, leadership, and relationship management skills.
• As a small biotech company, qualities that we seek include:
• Ability to handle multiple responsibilities and where different hats as needed in a dynamic work environment, and able to adapt quickly to new challenges and technologies.

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