Senior Director, Head of Clinical Operations

Role Summary

The Head of Clinical Operations provides strategic operational guidance to ensure clinical trials are properly planned and executed across all clinical stage programs. The role oversees all aspects of clinical trial execution, including GCP compliance on studies supporting the development of novel monoclonal antibodies aimed at preventing transmission of and/or treating infectious diseases, including SARS-CoV-2. Location: New Haven, CT (hybrid; onsite portion in New Haven, CT).

Responsibilities

• Oversee study management activities for global monoclonal antibody clinical research studies
• Responsible for clinical trial management activities on specified study in addition to local and global CRO oversight
• Lead selection and management / oversight of external vendors; develop standard vendor specifications; review vendor reports, budgets and forecasts, and metrics
• Review and negotiate contracts
• Forecast costs for clinical studies
• Review and approve invoices against approved budget/contract
• Monitor subject accrual and study progress via standard reports
• Oversee clinical monitoring from site qualification to site closure visits and ensure integrity of clinical data with respect to accuracy, accountability, and documentation through review of monitoring reports and completed case report forms
• Update program team and Clinical Operations management on timelines and progress toward milestones
• Apply Invivyd and industry standards across research program(s)
• Provide guidance to Clinical Operations Leads in oversight of vendors and investigators to ensure compliance with the study protocol and overall clinical objectives
• Collaborate with study leads to establish performance and quality metrics for the study and report metrics that drive quality and efficiency
• Work with Clinical Operations/Development management to support timely and in-budget completion of department goals by ensuring compliance and continuity with relevant SOPs and organizational work instructions
• Support departmental initiatives aimed at innovation, process improvement, and efficiency
• Develop or contribute to key vendor oversight plans and processes
• Assist with the development of standard operating procedures (SOPs), work instructions (WIs), and standardized forms to define Clinical Department processes
• Collaborate with Clinical, Regulatory, Safety, Quality, and other functional team members to ensure compliance of department/study activities with FDA regulations, guidelines, and principles of ICH GCP and Invivyd SOPs
• Ensure GCP compliance by providing guidance and support to Clinical study leads and Clinical Study Teams
• Support activities associated with QA audits: assist trial teams in responding to audit findings, ensuring root cause is identified and CAPAs are created; ensure documentation
• Manage direct reports, as applicable
• Limited travel (<20%) for site and vendor oversight

Qualifications

• Minimum education and experience: Bachelor’s degree with 10-15 years relevant experience
• Global study management at sponsor company
• Strong oral and written communication skills
• Experience with development and maintenance of study timelines and budgets
• Highly adaptable, proactive, deadline and detail-oriented
• High level of professional expertise through recent industry training and familiarity with good clinical practice and risk-based quality management best practices
• The candidate will work in a fast-paced and dynamic environment
• Ability to accommodate hybrid schedule with a mix of both onsite (New Haven, CT once a month) and remote working

Skills

• Global study management
• Vendor management and contract negotiation
• Budgeting and financial forecasting
• GCP compliance and quality management
• Clinical monitoring and data integrity
• Cross-functional collaboration
• SOP/WI development

Education

• Bachelor’s degree (required)

Additional Requirements

• Travel: Limited (<20%) for site and vendor oversight