Associate Director, Clinical Operations
Apply NowAssociate Director, Clinical Operations
San Francisco, California, United States
About the Job
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