Director, Safety Assessment

Altasciences; Seattle (WA); On-site; USD 126,000 - 200,000; Full time

Benefits offered by this job

Health Insurance

Paid Vacation & Holidays

Paid Sick Leave

Job summary

Altasciences is seeking a senior leader to direct the Safety Assessment department, ensuring GLP compliance, SOP development, and high-quality study design across preclinical programs.

You will mentor staff, approve protocols, and represent the company with regulatory agencies while supporting business development through client meetings.

Qualifications

• Ph.D./M.D./D.V.M. or Master with relevant training and experience.
• Seven+ years evaluating preclinical safety and toxicology in pharma/biotech or CROs.
• Experience leading groups or teams in a regulated environment.
• Five+ years managing preclinical safety and efficacy programs.
• Experience presenting safety reports for regulatory submissions.
• Broad exposure to GLP regulations and regulatory guidelines.

Responsibilities

• Direct GLP compliance initiatives and department strategy.
• Oversee SOPs, SSPs, policies, and training materials for procedures.
• Approve protocols and ensure scientific review of study reports.
• Engage in client meetings to support business development.
• Mentor staff on drug development, study design, and client management.
• Direct resources, budget, and personnel within the department.
• Assign Study Directors and cover responsibilities during substitutions.
• Represent the company to regulatory agencies including FDA.
• Ensure staff adherence to corporate directives and budgets.
• Plan activities for efficiency and cost-effectiveness.

Skills

GLP compliance leadership

Safety assessment management

Study design guidance

Regulatory liaison

Mentorship

Education

PhD in biomedical field

MD

DVM

Master-level in biomedical field

Job description

About The Role

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.

You'll Do Here

• 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.

What You'll Need to Succeed

• 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.

What We Offer

The salary range estimated for this position is $126,000 - $200,000. Please note that salaries vary within the range based on factors including, but not limited to, prior relevant experience, skills, education, certification, location as well as internal equity and market data.

Benefits

Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.

Altasciences' Benefits Package Includes:

• Health/Dental/Vision Insurance Plans
• 401(k)/RRSP with Employer Match
• Paid Vacation and Holidays
• Paid Sick and Bereavement Leave
• Employee Assistance & Telehealth Programs

Altasciences' Incentive Programs Include:

• Training & Development Programs
• Employee Referral Bonus Program