Toxicology Director

Toxicology Director – Permanent – San Francisco Bay Area

Proclinical is seeking a Toxicology Director for an exciting and rapidly growing biotechnology company based in the San Francisco, CA Bay Area.

Primary Responsibilities:

In this role, you will provide toxicology strategy and executional support across the company’s development programs. You 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 position is hybrid, requiring two days per week onsite in the San Francisco, CA Bay Area.

Skills & Requirements:

• PhD, DVM, or equivalent advanced degree in toxicology, pharmacology, pathology, immunology, or a related scientific discipline.
• 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 with biologics is a plus.
• 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.

The Toxicology Director will:

• 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.

If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at View phone number on click.appcast.io or View email address on click.appcast.io .

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.