Director, Safety Assessment

Altasciences•Everett, WA

6d•Onsite

About The Position

Responsible for directing the Safety Assessment department to ensure the attainment of operational excellence and quality. Ensures that departmental policies, objectives, and operation and communication network of the company supports the highest level of compliance and efficiency possible. Provides business development support by participating in client meetings and assisting Study Directors with study design to meet client needs.

Requirements

Ph.D. in relevant biomedical field, MD, DVM or Masters degree in combination with appropriate training and experience.
Minimum of seven years experience in evaluating pharmaceutical preclinical safety and toxicology studies in the pharmaceutical/biotech industry, in contract toxicology research organizations or similar organizations.
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; or equivalent combination of education and experience in industry / contract research organization (CRO) drug development.
Ability to read, analyze, and interpret scientific and technical journals, financial reports, and legal documents; the ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community; the ability to write speeches and articles for publication that conform to 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.
Requirements include training in GLP regulations and knowledge of ongoing toxicology, regulatory, laws, rules, and notices on guidelines concerning preclinical drug development, and business communication.
Continual GLP training.
Demonstrated ability to lead people and get results through others.
Ability to organize and manage multiple priorities.
Problem analysis and problem resolution at both a strategic and functional level.

Responsibilities

Leads the Good Laboratory Practices (GLP) compliance initiatives.
Oversees the development and implementation of strategic plans, policies and procedures to ensure department programs will meet or exceed internal and external customers’ needs and expectations.
Assures the development, review, revision and implementation of SOPs, SSPs, policies, training manuals and/or checklists relating to technical procedures, facility issues, and data generation.
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 assignments and allocations.
Designates Study Director to meet study objectives.
Replaces the Study Director promptly if it becomes necessary to do so during the conduct of a study.
Acts as company representative to regulatory agencies, including the FDA, and local regulatory agencies.
Ensures departmental staff is compliant with corporate directives.
Plans and directs activities to ensure operational efficiency and economy.
In conjunction with administrative personnel, reviews activity, operating, and budget reports to guide and direct programs or operations as required.
Manages Study Directors in Safety Assessment.
Is responsible for the overall direction, coordination, and evaluation of the department.
Approves department purchase orders and requests.
Initiates and responds to client inquiries regarding company policy and procedures.
Other duties as assigned.