Toxicology Director

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 SeattlePosition Title: Director of ToxicologyPosition Type: Direct hireSalary range: 125,000-200,000 per yearAbout the opportunityLead 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 doSet 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 bringA 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.