Director, Safety Assessment & GLP Leadership

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

Benefits offered by this job

Health Insurance

401(k) matching

Paid vacation

Sick leave

Telehealth programs

Job summary

Altasciences is seeking a Director of Safety Assessment to lead GLP compliance and the department’s strategic direction in preclinical drug development. You will supervise Study Directors, oversee SOP and protocol development, and coordinate with regulatory agencies to ensure scientific excellence and client satisfaction.

The role requires a PhD or MD/DVM with extensive experience in toxicology studies, strong writing and presentation skills, and a proven ability to manage teams and budgets

Qualifications

• Seven+ years evaluating preclinical safety and toxicology studies.
• Experience in management or supervision of groups or teams.
• Five+ years conducting preclinical safety and efficacy programs.
• Experience writing and presenting preclinical safety reports for regulatory submissions.
• At least 8 years related experience or training in CRO drug development.
• Ability to read and interpret scientific and regulatory documents; strong communication skills.
• Training in GLP regulations and ongoing toxicology guidelines.

Responsibilities

• Leads GLP compliance initiatives.
• Oversees development and implementation of strategic plans and SOPs.
• Reviews and approves protocols and related SOPs, SSPs, and training materials.
• Approves department budgets and resource allocations.
• Represents the company to regulatory agencies, including FDA.
• Mentors staff on drug development requirements and study design.
• Directs and evaluates department performance and study director assignments.
• Supports business development through client meetings.

Skills

Leadership

GLP knowledge

Regulatory/compliance

Scientific writing

Analytical skills

Communication skills

Education

PhD in biomedical field

MD

DVM

Master's degree

Job description

Altasciences is seeking a Director of Safety Assessment to lead GLP compliance and the department’s strategic direction in preclinical drug development. You will supervise Study Directors, oversee SOP and protocol development, and coordinate with regulatory agencies to ensure scientific excellence and client satisfaction.

The role requires a PhD or MD/DVM with extensive experience in toxicology studies, strong writing and presentation skills, and a proven ability to manage teams and budgets