Toxicology Director

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 opportunity with one of our clients, a leading CDMO in Greater Seattle, WA area. If you are driven by the prospect of translating cutting-edge scientific discoveries into tangible advancements and are poised to advance your career, join us as we pioneer progress in the biotechnology industry.

Workplace: Onsite in the Greater Seattle

Position Title: Director of Toxicology

Position Type: Direct hire

Salary range: 125,000-200,000 per year

About the opportunity

Lead a Safety Assessment organization focused on scientific excellence, operational performance, and the highest standards of quality and GLP compliance. In this senior role, you’ll guide departmental strategy and resources, develop strong teams, and help ensure preclinical safety studies meet scientific, regulatory, and client needs. You’ll also work closely with clients and Study Directors, contributing to study design, supporting client relationships, and helping advance drug development programs.

What you’ll do

• Set departmental strategy, objectives, and operating practices to deliver high-quality, efficient services that meet internal and client expectations.
• Lead GLP compliance initiatives and ensure staff follow applicable corporate requirements and regulatory guidance.
• Oversee the creation, review, revision, and implementation of SOPs, study-specific procedures, policies, training materials, and checklists.
• Provide administrative approval of study protocols and ensure appropriate scientific review of study reports and other deliverables.
• Manage and mentor Study Directors; designate Study Directors to meet study objectives and ensure timely replacement when needed.
• Support business development and client management by participating in client meetings, responding to inquiries, and helping shape study designs.
• Coach staff on drug development requirements, study design, and effective client management.
• Direct departmental staffing, personnel decisions, budgets, resource planning, and allocations.
• Plan and lead operations to promote efficiency and responsible use of resources; review activity, operational, and budget reports with administrative colleagues.
• Represent the organization in interactions with the FDA and other regulatory agencies, as appropriate.
• Approve departmental purchase orders and requests.
• Take on additional responsibilities as needed.

What you’ll bring

• A Ph.D. in a relevant biomedical field, an M.D. or D.V.M., or a master’s degree combined with appropriate training and experience.
• At least eight years of related experience in industry, a contract research organization, or a comparable drug development setting.
• At least seven years of experience evaluating pharmaceutical preclinical safety and toxicology studies.
• At least five years of experience conducting, developing, and managing preclinical safety and efficacy programs.
• Experience managing or supervising teams, with a demonstrated ability to lead effectively and achieve results through others.
• Experience authoring and presenting preclinical safety reports in support of regulatory submissions.
• Strong knowledge of GLP regulations and the regulatory requirements, guidance, and standards relevant to preclinical drug development; a commitment to ongoing GLP training.
• Excellent written, verbal, and presentation skills, including the ability to interpret technical and scientific material and communicate it clearly to varied audiences.
• The ability to analyze scientific, statistical, financial, and operational information and present findings to staff and senior leadership.
• Strong organization, prioritization, problem-solving, and decision-making skills, including the ability to manage multiple priorities at both strategic and operational levels.