Director, Safety Assessment

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

Benefits offered by this job

Health/Dental/Vision Insurance Plans

401(k)/RRSP with Employer Match

Paid Vacation and Holidays

Paid Sick and Bereavement Leave

Employee Assistance & Telehealth

Training & Development Programs

Employee Referral Bonus

Job summary

Altasciences Preclinical Seattle LLC is seeking a senior leader to direct the Safety Assessment department, ensuring GLP compliance, strategic planning, and efficient operations. You will mentor staff, coordinate with Study Directors, and engage with clients and regulators to meet study objectives and quality standards.

The role requires advanced degrees in biomedical fields, extensive preclinical safety experience, and strong communication skills for regulatory submissions and client

Qualifications

• Ph.D. in biomedical field or MD/DVM; master’s with relevant training may apply.
• Minimum seven years evaluating preclinical safety and toxicology in pharma/biotech, CROs, or similar.
• Experience leading groups or teams in a regulated environment.
• Experience writing and presenting preclinical safety reports for regulatory submissions.
• GLP training and knowledge of regulatory guidelines for preclinical drug development.

Responsibilities

• Direct GLP compliance initiatives and oversee department policies and SOPs.
• Lead strategic planning and resource management for Safety Assessment programs.
• Mentor staff on drug development, client management, and study design.
• Engage with regulatory agencies and support business development activities.

Skills

Leadership

GLP compliance

Regulatory communications

Scientific writing

Education

Ph.D. in relevant biomedical field

MD

DVM

Masters degree with appropriate training

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
• Training & Development Programs
• Employee Referral Bonus Program #LI-AN1

At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them. No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team! Whether you're a recent college graduate or seeking your next career opportunity, it's time to discover your future at Altasciences. We are better together and together We Are Altasciences.

Altasciences is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation. Reasonable accommodations for persons with disabilities during the recruitment process are available upon request.