Head of Safety Assessment & GLP Compliance

CareAbout; Everett (WA); On-site; USD 126,000 - 200,000; Full time

Benefits offered by this job

Health/Dental/Vision Insurance Plans

401(k)/RRSP with Employer Match

Paid Vacation and Holidays

Paid Sick and Bereavement Leave

Employee Assistance & Telehealth

Job summary

Altasciences is seeking a senior leader to direct the Safety Assessment department, ensuring GLP compliance, strategic planning, and effective study design. The role oversees SOPs, protocol approvals, and scientific reviews while coordinating with clients and regulators.

The position requires a Ph.D. or equivalent, extensive preclinical safety experience, and proven leadership. Competitive salary and comprehensive benefits are offered.

Qualifications

• Ph.D. in relevant biomedical field, MD, DVM or Masters degree with appropriate training and experience.
• Minimum of seven years experience in evaluating pharmaceutical preclinical safety and toxicology studies in the pharma/biotech industry, contract toxicology research organizations or similar.
• Previous experience in management or supervision of groups or teams.
• Minimum of 5 years experience in conducting, developing, and managing preclinical safety and efficacy programs.
• Experience in writing and presenting preclinical safety reports to support regulatory submissions.
• At least 8 years related experience and/or training in CRO drug development.
• 3-5 years related experience
• No certificates, licenses or registrations are required. DABT is desirable
• Ability to read, analyze, and interpret scientific and technical journals, financial reports, and legal documents; ability to respond to inquiries from customers/regulatory agencies; ability to write speeches/articles.
• Excellent written and verbal communication skills including the ability to create and present high-quality scientific presentations.
• Ability to apply advanced mathematical and statistical evaluations to scientific and business data.

Responsibilities

• Leads the Good Laboratory Practices (GLP) compliance initiatives.
• Oversees development and implementation of strategic plans, policies and procedures to ensure department programs meet internal and external needs.
• Assures development, review, revision and implementation of SOPs, SSPs, policies, training manuals and checklists.
• Provides administrative approval of Protocols.
• Ensures appropriate scientific review of study reports and other deliverables.
• Participates in client meetings to support business development and client management activities.
• Mentors staff regarding drug development requirements, client management, and study design.
• Directs and approves departmental resources, personnel, fiscal allocations.
• Designates Study Director to meet study objectives and replaces if necessary.
• Represents company to regulatory agencies including FDA and local bodies.
• Ensures departmental staff compliance with corporate directives.
• Plans and directs activities for operational efficiency and economy.
• Reviews activity, operating, and budget reports with admin staff to guide programs.
• Manages Study Directors in Safety Assessment.
• Is responsible for overall direction, coordination, and evaluation of the department.
• Approves department purchase orders and requests.
• Initiates and responds to client inquiries regarding policy and procedures.
• Other duties as assigned.
• Supervisory responsibilities including hiring, training, and performance management.

Education

Ph.D. in relevant biomedical field, MD, DVM or Masters degree

Job description

Altasciences is seeking a senior leader to direct the Safety Assessment department, ensuring GLP compliance, strategic planning, and effective study design. The role oversees SOPs, protocol approvals, and scientific reviews while coordinating with clients and regulators.

The position requires a Ph.D. or equivalent, extensive preclinical safety experience, and proven leadership. Competitive salary and comprehensive benefits are offered.