Toxicology Director

Proclinical Staffing; San Francisco (CA); Hybrid; USD 150,000 - 200,000; Full time

Job summary

Proclinical Staffing is looking for a Toxicology Director for a dynamic biotech company in the San Francisco Bay Area. This hybrid role involves designing and overseeing nonclinical safety studies, providing scientific guidance on toxicology, and managing external partners.

The ideal candidate will possess a PhD or equivalent and have more than 10 years of experience in biotechnology or pharmaceutical development. Strong regulatory submission skills are essential, as well as the ability to interpret complex toxicology data.

Qualifications

• 10+ years of relevant experience in biotechnology or pharmaceutical development.
• Ability to interpret complex toxicology findings and communicate their relevance.

Responsibilities

• Develop and execute nonclinical toxicology strategies.
• Serve as toxicology representative on cross-functional teams.
• Design and oversee IND-enabling toxicology studies.

Skills

Expertise in nonclinical safety assessment of small molecules

Experience with biologics

Strong knowledge of GLP requirements

Regulatory submission experience

Management of CROs and consultants

Education

PhD, DVM, or equivalent advanced degree

Job description

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 ([phone] or [e-mail].

Proclinical Staffing is an equal opportunity employer.