Senior Director, Safety Assessment

Your New Company!
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.

The Altasciences team in Columbia is growing! Join a Team Where Your Leadership and Passion Truly Matter

Are you a dynamic, self-motivated professional with a passion for driving positive change and inspiring others? We're looking for someone who thrives in a collaborative environment, excels at building strong relationships, and knows how to lead with both heart and strategy. If you're organized, adaptable, and energized by new challenges, this is your opportunity to make a real impact. Bring your enthusiasm, your leadership, and your drive for excellence—and help us shape the future while boosting team morale and achieving shared goals. Ready to lead the way? We’re excited to meet you.

About the Role

The Senior Director, Safety Assessment, oversees the management of the Safety Assessment department to ensure scientific and operational excellence and quality of the studies conducted and reported by the department.  Ensures that departmental policies, SOPs, objectives 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. Works across the organization with leaders across sites to harmonize processes to provide a high-quality consistent experience for our clients.

What You'll do Here

• Is responsible for the overall direction, coordination, and evaluation of the department.

• Mentors staff regarding drug development requirements, client management, and study design.

• Leads the Good Laboratory Practices (GLP) compliance initiatives within the department.

• Serves as an alternate for Test Facility Management responsibilities as assigned.

• In conjunction with other site leadership, develops and implements strategic plans, new capabilities, policies and procedures to ensure department programs will meet or exceed internal and external customers’ needs and expectations.

• Plans and directs activities to ensure use of best practices, process improvements and operational efficiency.

• Assures the development, review, revision, and implementation of training material for the Safety Assessment team to support the attainment of scientific and regulatory excellence.

• Ensures appropriate scientific review of study protocols, reports and other deliverables.

• Serves as a scientific expert for studies during audits, on project teams, committees, and other assignments.

• Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws and is responsible for performance management of direct report(s).

• Ensure appropriate designation of Study Directors to meet study objectives and prompt replacement of the Study Director if it becomes necessary to do so during the conduct of a study.

• Participates in client meetings to support business development and client management activities.

• Acts as company representative to regulatory agencies, including the FDA, and local regulatory agencies.

• In conjunction with administrative personnel, reviews activity, operating, and budget reports to guide and direct programs or operations as required.

What You'll Need to Succeed

• PhD in relevant biomedical field; MD, DVM or Masters degree in combination with appropriate training and experience considered

• 7+ years related experience in preclinical safety and toxicology evaluation in CRO or similar industry

• 5+ years conducting, developing, and managing preclinical safety and efficacy programs

• Experience in writing and presenting preclinical safety reports to support regulatory submissions

• 8 years related experience and/or training; or equivalent combination of education and experience in industry/CRO drug development

• 3+