Director, Safety Assessment & GLP Compliance

Altasciences; Everett (WA); Hybrid; USD 126,000 - 200,000; Full time

Benefits offered by this job

Health/Dental/Vision Insurance

401(k) with Employer Match

Paid Vacation and Holidays

Paid Sick and Bereavement Leave

Employee Assistance & Telehealth

Job summary

Altasciences in Everett, Washington, is seeking a Director of Safety Assessment to lead the department toward operational excellence and compliance with GLP and regulatory expectations. The role includes guiding study design, SOP development, and client engagement to meet scientific and business objectives.

The successful candidate will have senior preclinical safety experience, strong leadership, and proven ability to manage budgets and personnel while representing the company to regulatory

Qualifications

• Ph.D./MD/DVM or master's with relevant experience in preclinical safety.
• 7+ years evaluating pharmaceutical preclinical safety studies.
• 5+ years in management or supervision.
• 8+ years related experience in CRO drug development.
• Ability to read and interpret scientific/technical materials.
• Excellent written and verbal communication; capable of high-quality presentations.
• GLP training and knowledge of regulatory guidelines.

Responsibilities

• Lead GLP compliance initiatives.
• Oversee SOPs, SSPs, policies and training materials.
• Approve Protocols and ensure scientific review of study reports.
• Support business development and client meetings; assist Study Directors with study design.
• Mentor staff on drug development and client management.
• Direct resources, personnel, and budgets; designate Study Director.
• Represent company to regulatory agencies (FDA and others).
• Ensure staff compliance with corporate directives.
• Plan and direct operational efficiency; review budgets.
• Manage Study Directors in Safety Assessment; overall department direction.
• Approve department purchase orders.
• Respond to client inquiries regarding policy.

Skills

GLP compliance

Team leadership

Scientific writing

Regulatory submissions

Study design

Drug development knowledge

Budget management

Education

Ph.D. in relevant biomedical field

MD

DVM

Masters degree with relevant experience

Job description

Altasciences in Everett, Washington, is seeking a Director of Safety Assessment to lead the department toward operational excellence and compliance with GLP and regulatory expectations. The role includes guiding study design, SOP development, and client engagement to meet scientific and business objectives.

The successful candidate will have senior preclinical safety experience, strong leadership, and proven ability to manage budgets and personnel while representing the company to regulatory