Director, Safety Assessment

Altasciences•Everett, WA

1d•$126,000 - $200,000

About The Position

The Director, Safety Assessment directs the Safety Assessment department to achieve operational excellence, quality, compliance, and efficiency. The role oversees departmental strategy, policies, procedures, resources, personnel, and budgets, and supports business development and client management through client meetings and assistance with study design. The Director ensures appropriate scientific review of study reports and other deliverables, provides administrative approval of protocols, and leads Good Laboratory Practices (GLP) compliance initiatives. The Director manages Study Directors and the department’s overall direction, coordination, and evaluation. The role represents the company to regulatory agencies, including the FDA and local agencies, and ensures staff compliance with corporate directives. Supervisory responsibilities include interviewing, hiring, training, assigning and directing work, evaluating performance, rewarding and disciplining employees, and resolving complaints and problems. Other duties may be assigned.

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, a contract toxicology research organization, or a similar organization.
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.
Ability to read, analyze, and interpret scientific and technical journals, financial reports, and legal documents; respond to inquiries or complaints from customers, regulatory agencies, or business community members; and write speeches and articles 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 current toxicology, regulations, laws, rules, and notices 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.
Develop and implement strategic plans, policies, and procedures to ensure departmental programs meet or exceed customer needs and expectations.
Ensure the development, review, revision, and implementation of SOPs, SSPs, policies, training manuals, and checklists relating to technical procedures, facility issues, and data generation.
Provide administrative approval of protocols and 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 when 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 programs or operations.
Manage Study Directors in Safety Assessment and direct, coordinate, and evaluate the department.
Approve department purchase orders and requests.
Initiate and respond to client inquiries regarding company policies and procedures.
Interview, hire, and train employees; plan, assign, and direct work; appraise performance; reward and discipline employees; address complaints and resolve problems.
Perform other duties as assigned.