Associate Director, Clinical Operations
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Job Description
Associate Director leading global clinical trial execution for Kite, a biopharmaceutical company developing CAR T-cell cancer immunotherapies. Managing programs, CROs, budgets, timelines, and Clinical Operations teams.
Responsibilities:
- Lead teams of direct and indirect reports and manage talent development
- Provide input into strategic and operational therapeutic-area and functional-area plans
- Provide leadership, guidance, oversight, and therapeutic expertise for clinical trials
- Provide strategic, operational, and financial oversight of assigned programs
- Develop, implement, manage, and complete clinical trials within budgets and timelines
- Set strategic vision for clinical trials and programs through cross-functional collaboration
- Assess, onboard, and manage CROs and other vendors, including RFPs and selection processes
- Contribute to Clinical Development Programs as a Clinical Sub-Team member and potentially Global Development Team member
- Lead cross-functional Study Management Teams and influence stakeholders
- Analyze project status and issues and implement risk mitigation strategies
- Solve problems involving national and international regulations, guidelines, and investigator interactions
- Communicate project status and issues to stakeholders
- Track, oversee, and communicate program status
- Contribute leadership input to study documentation, including protocols
- Oversee affiliate Clinical Operations activities required by local regulations or practice
- Initiate, author, contribute to, implement, and train on SOPs
- Ensure team compliance with practices, policies, processes, and regulatory requirements
- Create inclusion, develop talent, and empower teams
Requirements:
- Bachelor's Degree and Ten Years' Experience OR Masters' Degree and Eight Years' Experience OR PhD/PharmD and Two Years' Experience
- Minimum of 6 years’ cross-functional study management or related leadership experience in life sciences (preferred)
- Experience developing RFPs and selecting and managing CROs or other vendors
- Multiple years’ line management experience
- Experience managing clinical studies within designated program budgets and timelines
- Expertise authoring clinical study and regulatory documentation and SOPs
- Meets all requirements for Clinical Program Manager (CPM) grade 29 position with demonstrable proficiency
- Expert knowledge of one or more disease or therapeutic areas
- Complete knowledge of full-cycle study management, from start-up to close-out
- Advanced knowledge of study management best practices and tools
- Thorough knowledge of FDA, EMA, applicable national regulations, ICH guidelines, and GCP
- Strong financial acumen for clinical trial budget management
- Strong leadership, interpersonal, communication, organizational, negotiation, and conflict resolution skills
- Demonstrated ability to lead without authority and influence programs, projects, and initiatives
- Demonstrated capabilities in hiring, managing, and developing diverse talent
- Demonstrated effectiveness in proactively managing change
- Ability to travel when needed
Benefits:
- Discretionary annual bonus
- Discretionary stock-based long-term incentives
- Paid time off
- Company-sponsored medical insurance
- Company-sponsored dental insurance
- Company-sponsored vision insurance
- Company-sponsored life insurance
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