Company: SNBL (Shin Nippon Biomedical Laboratories, Ltd)
Location: Everett, WA
Job Type: Full-Time
For more than 55 years, SNBL (Shin Nippon Biomedical Laboratories, Ltd) has been a leader in helping biopharmaceutical companies generate high quality data with the exceptional precision needed to rapidly advance new medical therapies and innovations that improve patients™ lives, SNBL has facilities in Japan, the United States, China, and Cambodia. Our international footprint enables us to meet the research needs of clients around the globe. We are committed to providing our customers with fast and precise results across the entire drug development spectrum, from early discovery research to late-stage clinical trials.
The SNBL team is dedicated as a company and as individuals in working with our clients to improve patient care and treatment outcomes. This is a cornerstone in our drive for excellence across all aspects of our business.
The Director of Safety Assessment is responsible for directing the Safety Assessment department to ensure the attainment of operational excellence and profit goals. Participates with the Executive Management Team in formulating current and long-range plans, objectives and policies. Ensures that the departmental policies, objectives and operation and communication network of the company supports the highest level of compliance and efficiency possible.
• 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.
• Directs and approves departmental resources, personnel, fiscal assignments and allocations.
• Designates Study Director, Principal Scientist, Contributing Scientist and Principal Investigator to meet Study objectives.
• Assigns Study Staff as appropriate to meet Study objectives.
• Acts as company representative to regulatory agencies, including the FDA, and local regulatory agencies.
• Ensures departmental managers are compliant with corporate directives.
• Plans and directs activities to ensure operational efficiency and economy.
• Plans, develops and manages budgets to meet or exceed department(s) and company goals.
• In conjunction with administrative personnel, reviews activity, operating, and budget reports to guide and direct programs or operations as required.
• Replaces the Study Director and Principal Investigator promptly if it becomes necessary to do so during the conduct of a study.
• Manages Study Directors, Study Supervisors, and Study Coordinators 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.
• Carries out supervisory responsibilities in accordance with the organization\’s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
• Ph.D. in relevant biomedical field, MD, DVM, Masters or BS 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. A 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.
• 3-5 years related experience
• DABT is desirable
• Advanced computer skills required.
• 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.
For more information about SNBL USA and to apply for this position please go to https://careers-snblusa.icims.com/.
Apply Here: http://www.Click2Apply.net/gcr5vnp
An equal opportunity employer, M/F/D/V.
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