Senior Director, Toxicology & Preclinical Safety

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

Job summary

Kelly Science & Clinical is seeking a Director of Toxicology for a direct-hire role in the Greater Seattle area. This senior leadership position guides safety assessment strategy, GLP compliance, and resourcing to support preclinical programs for a leading CDMO.

You will interact with Study Directors, contribute to study designs, and oversee regulatory affairs-related activities while managing budgets and departmental operations onsite in Seattle. A Ph.D.

Qualifications

• Ph.D. in biomedical field, M.D. or D.V.M., or master's with appropriate training and experience.
• At least eight years in industry/CRO or similar drug development setting.
• At least seven years evaluating pharmaceutical preclinical safety and toxicology studies.
• At least five years leading preclinical safety and efficacy programs.

Responsibilities

• Set departmental strategy, objectives, and operating practices to deliver high-quality services that meet expectations.
• Lead GLP compliance initiatives and ensure staff follow regulatory guidance.
• Oversee SOPs, study-specific procedures, and training materials development.
• Approve study protocols and ensure review of study reports and deliverables.
• Manage and mentor Study Directors and assign replacements as needed.
• Support business development and client management through meetings and study design input.
• Coach staff on drug development requirements and client management.

Skills

GLP compliance

Leadership

Study design

Preclinical safety

Regulatory submissions

Client management

Communication

Budget planning

Resource planning

Team mentoring

Education

Ph.D. in biomedical field

MD or D.V.M.

Master's degree with relevant training

Job description

Kelly Science & Clinical is seeking a Director of Toxicology for a direct-hire role in the Greater Seattle area. This senior leadership position guides safety assessment strategy, GLP compliance, and resourcing to support preclinical programs for a leading CDMO.

You will interact with Study Directors, contribute to study designs, and oversee regulatory affairs-related activities while managing budgets and departmental operations onsite in Seattle. A Ph.D.