Director of Toxicology & Preclinical Safety

Kelly Services; Everett (WA); On-site; USD 125,000 - 200,000; Full time

Benefits offered by this job

Medical/dental/vision

Retirement savings plan

Holiday pay

Transit spending account

Job summary

Kelly Science & Clinical is seeking a Director of Toxicology for a leading CDMO in the Greater Seattle area. This on-site role requires guiding a non-clinical safety organization, ensuring GLP compliance, and aligning studies with regulatory and client needs.

You will lead departmental strategy, mentor Study Directors, and collaborate with Study Directors and clients to shape study designs and deliver high-quality results. A Ph.D. or equivalent is required with extensive industry experience.

Qualifications

• Strong leadership and people-management capabilities.
• Experience in preclinical safety and toxicology.
• Extensive knowledge of GLP regulations and regulatory expectations.
• Excellent written and verbal communication for regulatory submissions.
• Ability to lead cross-functional teams and drive strategic objectives.
• Proven track record in study design and client management.

Responsibilities

• Set departmental strategy, objectives, and operating practices.
• Lead GLP compliance initiatives and ensure staff follow regulatory guidance.
• Oversee SOPs, study procedures, and training materials.
• Approve study protocols and review study reports.
• Mentor Study Directors and ensure timely coverage.
• Support business development and client management.
• Coach staff on drug development requirements and client relations.
• Direct staffing, budgets, and resource planning.
• Lead operations to optimize efficiency and resource use.
• Represent the organization with the FDA and other regulators.
• Approve departmental purchase orders and requests.
• Take on additional responsibilities as needed.

Skills

Leadership

Team management

Preclinical safety

Regulatory communication

Problem solving

Strategic planning

GLP compliance

Education

Ph.D./M.D./D.V.M. or master's in biomedical field

Job description

Kelly Science & Clinical is seeking a Director of Toxicology for a leading CDMO in the Greater Seattle area. This on-site role requires guiding a non-clinical safety organization, ensuring GLP compliance, and aligning studies with regulatory and client needs.

You will lead departmental strategy, mentor Study Directors, and collaborate with Study Directors and clients to shape study designs and deliver high-quality results. A Ph.D. or equivalent is required with extensive industry experience.