Director of Toxicology

Primary Responsibilities:

• Provide expert scientific and regulatory guidance on toxicology-related matters, ensuring scientific integrity and compliance with relevant guidelines and standards. 
• Review and approve toxicology protocols, reports, and client deliverables. 
• Stay current on developments in toxicology, regulatory expectations, and emerging methodologies. 
• Provide strategic guidance on toxicology, risk assessment, and client engagement strategies, ensuring a balance between business objectives and client expectations. 
• Lead initiatives to enhance team performance, process consistency, and quality assurance in all deliverables. 
• Drive continuous improvement initiatives, leveraging metrics and feedback to enhance the proposal development lifecycle. 
• Collaborate with finance and leadership to develop and manage departmental budgets, resource allocation, and cost optimization strategies. 
• Support proposal development and pricing strategies for toxicology services. 
• Monitor financial performance and implement strategies to meet or exceed revenue and margin goals. 
• Serve as a key point of contact for clients on toxicology projects, providing strategic and scientific insight throughout the project lifecycle. 
• Cultivate strong client relationships to ensure satisfaction, repeat business, and long-term partnership growth. 
• Partner with business development teams to support new business opportunities and client proposals. 
• Define and track key performance indicators (KPIs) to monitor the effectiveness, efficiency, and quality of toxicology operations. 
• Lead continuous improvement initiatives to optimize workflows, enhance quality, and streamline processes. 
• Prepare and present operational and strategic updates to executive leadership. 
• Lead, mentor, and develop the Toxicology Team, ensuring a high-performance culture that emphasizes collaboration, accountability, and continuous improvement. 
• Oversee resource planning, workload balancing, and performance management for the Toxicology team. 
• Establish clear goals and performance metrics for the team, ensuring alignment with corporate objectives. 
• Provide guidance on best practices for proposal writing, pricing strategy, and client negotiations, supporting professional growth and team success. 
• Oversee talent acquisition, onboarding, and training initiatives for new hires within the proposal development function.
•  This position will have direct people management responsibilities.  

Requirements:

• Bachelor level degree in Toxicology, Pharmacology or related field.   
• Advanced Degree preferred. 
• Demonstrated 5 years technical/scientific writing experience in the medical device industry required. 
• 7 years of regulatory or product development experience in the medical device industry preferred. 
• Deep technical expertise in preclinical toxicology studies and regulatory expectations (e.g., GLP, FDA, OECD).
• Extensive team and people management experience
• Proven ability to manage teams, budgets, and complex projects in a dynamic, client-focused environment. 
• Strong business acumen with experience in financial planning, budgeting, and strategic decision-making. 
• Exceptional communication, leadership, and organizational skills. 
• Experience with client engagement, proposal support, and delivering scientific presentations to external stakeholders  
• Strong logic, and ability to understand and assimilate complex testing concepts. 
• Establishes and maintains effective relationships with customers and gains their trust and respect. 
• Experience working collaboratively with clients, peers, and cross-functional teams.     
• High performance orientation, detail orientation, and strong organizational skills.  
• Ability to problem-solve, think strategically, and respond appropriately to customer needs.  
• 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 patient safety. 

Behaviors:

• 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