Job Openings
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.
• 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.