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.