Director of Scientific Operations

Role Summary

The Director of Scientific Operations is responsible for operational oversight and management of scientific operations supporting the safety assessment function at Northern Bio. The Director's core role is to provide vision, leadership, and decision-making to drive the success and growth of scientific operations with a strong emphasis on operational excellence, client satisfaction, financial performance, and team leadership.

Role Responsibilities

• Lead, mentor, and develop the Scientific Operations teams ensuring a high-performance culture that emphasizes collaboration, accountability, and continuous improvement.
• Partner with business development teams to support new business opportunities, client proposals and pricing strategies.
• Coordinate with the scheduling department and lead decision-making regarding operational priorities and provide information on the feasibility of prospective projects to ensure optimal study results and workload balancing across the Scientific Operations Teams.
• Define and track key performance indicators (KPIs) to monitor the effectiveness, efficiency, and quality of operations and establish clear goals for the teams, ensuring alignment with corporate objectives.
• Serve as the liaison between the operational staff, support services and senior management.
• Work together with finance and leadership to develop, manage and monitor departmental budgets, resource allocation, and cost optimization strategies.
• Collaborate with senior management to communicate expectations and business needs and ensure departmental performance and compliance with policies and regulations.
• Supervise development of scientific expertise within the Scientific Operations Teams ensuring opportunities for growth and accountability as needed.
• Provide expert scientific and regulatory guidance, ensuring scientific integrity and compliance with relevant guidelines and standards.
• Ensure scientific services staff maintain Good Laboratory Practices (GLP).
• Serve as Test Facility Management (TFM).
  • Responsible for ensuring personal and company compliance with all federal, state, local and company regulations, policies, and procedures.
  • Performs other duties assigned as needed.

Role Requirements

• Bachelor’s, Master’s, or PhD Degree in a life sciences discipline.
• Minimum of 7 years of CRO or related experience is required.
• Minimum of 5 years of management/leadership experience required.
• Advanced understanding of operational procedures in a pre-clinical/bioanalytical environment and the ability to resolve complex issues.
• Experience leading and developing cross-functional teams.
• Proficiency with Microsoft Office core applications and the ability to learn and use additional applications.
• Excellent understanding of study design and protocols.
• Advanced understanding of laboratory operations and data collection.
• Knowledge of GLPs and other federal regulations relating to drug development and care of laboratory animals.
• In depth understanding of GLP Test Article Management.
• In depth understanding of GLP Archive Management.
• Demonstrated experience in Quality System Management.
• Demonstrated experience in Project Management.
• Excellent written and oral communication skills.

Behavioral Expectations

• Leadership
• Collaboration
• Communication
• Teamwork
• Detail oriented
• Decision Making/Critical Thinking/Problem Solving

Special Requirements

• Flexibility Customer Focus, Action-Oriented, Approachability, Building Effective Teams, Business Acumen, Career Ambition, Composure, Courage (Managerial), Decision Quality, Informing, Integrity & Trust, Interpersonal Savvy, Planning, Time Management
• Ability to think strategically
• Able to speak effectively before groups
• Self-motivated individual with a "lead by example" approach that endorses the company's values and culture.
• Strong commitment to professional and scientific integrity, compliance, and safety.
• Demonstrated experience in GLP study execution for regulatory submission.
• Ability to multitask and work in a fast-paced environment.