Director, Safety Assessment

Altasciences•Everett, WA

2d•$126,000 - $200,000

About The Position

The Director, Safety Assessment leads the Safety Assessment department and is responsible for its operational excellence, quality, compliance, and efficiency. The role directs departmental programs, policies, procedures, resources, personnel, budgets, and overall operations, while ensuring that internal and external customer needs are met. The Director also supports business development and client management by participating in client meetings and helping Study Directors design studies to meet client needs. The position oversees Good Laboratory Practices (GLP) compliance, scientific review of study deliverables, administrative protocol approvals, and department documentation and training materials. It manages Study Directors, designates Study Directors to meet study objectives, and arranges prompt replacements when needed. The Director represents the company to regulatory agencies, including the FDA, and carries out supervisory responsibilities such as hiring, training, assigning and directing work, evaluating performance, and addressing employee complaints and problems.

Requirements

Ph.D. in a relevant biomedical field, MD, DVM, or a master's degree combined with appropriate training and experience.
At least seven years of experience evaluating pharmaceutical preclinical safety and toxicology studies in the pharmaceutical or biotech industry, contract toxicology research organizations, or similar organizations.
Previous experience managing or supervising groups or teams.
At least five years of experience conducting, developing, and managing preclinical safety and efficacy programs.
Experience writing and presenting preclinical safety reports to support regulatory submissions.
At least eight years of related experience and/or training, or an equivalent combination of education and experience in industry or CRO drug development.
Three to five years of related experience.
Ability to read, analyze, and interpret scientific and technical journals, financial reports, and legal documents; respond to common inquiries or complaints from customers, regulatory agencies, or business community members; and write speeches and articles for publication in a prescribed style and format.
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 for interpretation and presentation to staff and upper management.
Training in GLP regulations and knowledge of ongoing toxicology, regulatory requirements, laws, rules, notices, and guidelines concerning preclinical drug development, as well as business communication.
Continual GLP training.
Demonstrated ability to lead people and achieve results through others.
Ability to organize and manage multiple priorities.
Ability to analyze and resolve problems at strategic and functional levels.

Nice To Haves

DABT certification is desirable.

Responsibilities

Lead Good Laboratory Practices (GLP) compliance initiatives.
Oversee development and implementation of strategic plans, policies, and procedures to ensure department programs meet or exceed customer needs and expectations.
Ensure development, review, revision, and implementation of SOPs, SSPs, policies, training manuals, and checklists related to technical procedures, facility issues, and data generation.
Provide administrative approval of protocols.
Ensure appropriate scientific review of study reports and other deliverables.
Participate in client meetings to support business development and client management.
Mentor staff on drug development requirements, client management, and study design.
Direct and approve departmental resources, personnel, fiscal assignments, and allocations.
Designate Study Directors to meet study objectives and promptly replace a Study Director if necessary during a study.
Represent the company to regulatory agencies, including the FDA and local regulatory agencies.
Ensure departmental staff comply with corporate directives.
Plan and direct activities to ensure operational efficiency and economy.
Review activity, operating, and budget reports with administrative personnel to guide and direct programs or operations as required.
Manage Study Directors in Safety Assessment and provide overall direction, coordination, and evaluation of the department.
Approve department purchase orders and requests.
Initiate and respond to client inquiries regarding company policies and procedures.
Carry out supervisory responsibilities, including interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; and addressing complaints and resolving problems.
Perform other duties as assigned.