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.