Associate Director, Clinical Operations

About the job Associate Director, Clinical Operations Key Responsibilities • Team Management - Provide leadership and direction to Clinical Program Leads : • Recruit, manage, train and develop staff. • Motivate and manage team members through setting of individual goals, providing on-going feedback, and performance evaluations. • Delegate and provide general oversight of collaborations by providing program management level guidance to direct reports. • Provide matrix support for staff in Clinical Operations on design initiatives to enable critical thinking, planning, prioritization, adherence to study needs and escalation as needed. • Facilitate team meetings by creating agendas, identifying priorities/working groups and distributing communications/minutes. • Oversee staff expenditures. • Manage resources according to department strategy. • Review staff deliverables. • Program Management, Cross-Functional Leadership & Collaboration: • Strategically represent Clinical Operations on cross-FMI initiatives and governance committees (LCT). • Recognize and scope value-generating opportunities in the context of new and existing collaborations by bringing together a team of internal stakeholders as a trial/product design and plans are being built out. • Contribute as a thought-partner for innovative study design and execution plans. • Oversee Sponsored research including protocol and consent development, IRB submissions and interactions with Regulatory Authorities. • Initiate contracting discussion with legal and external collaborator and maintain a comprehensive knowledge of each executed agreement to ensure progress against deliverables. • Meet with internal stakeholders on alignment and towards achievement of project goals, adequate resource availability for delivery on commitments. • Assist in preparation for internal and external leadership presentations when requested. • External Relationship Management: • Establish strong partnership/relationship with internal and external stakeholders. • Ensure proactive and effective communication internally and externally. • Support partnership negotiations as opportunities for improvements arise. • Ensure consistent execution of Clinical Operations strategy, processes and procedures: • Contribute to design and development of Clinical Operations strategy. • Oversee execution of department strategy. • Monitor execution of processes to determine points of failure. • Identify and mitigate against study risks, partnering with the appropriate internal stakeholders to document any deviations, and analyze/build solutions as appropriate. • Support regulatory authority and Sponsor audits and inspections. • Escalate compliance issues/risks to Clinical Operations, Medical and biopharma leadership. • Create and execute monthly, quarterly and annual financial, capacity and resource planning with department leadership team in close collaboration with Finance and HR Business Partners. • Collaborate with internal Technology team in prioritization for development, testing and roll-out of new and updated systems and delegation of appropriate tasks to Principal and/or Senior CPL. • Contribute to the development and execution of Clinical Operations goals and initiatives: • Sponsor departmental or cross-functional projects and initiatives. • Lead and/or sponsor internal initiatives to improve Clinical Operations processes and tools. • Maintain knowledge of current GCP and CGP regulations and guidelines and company policies, SOPs and procedures. • Other duties as assigned.

Created: 2026-03-10