Associate Director, FSP Clinical Operations / FSP Program Lead

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide direct line management for FSP Clinical Operations managers and staff while overseeing Client accounts.

• Support the business objectives of FSP Clinical Operations by ensuring timely and high-quality deliverables.

• Allocate qualified staff to Client projects, focusing on retention and staff development.

• Contribute to new business initiatives by engaging in project bids and Client presentations as needed.

• Oversee and execute Program Management activities related to one or more programs.

• Act as the central point of contact (POC) between Senior Management and key Client personnel for contracted FSP Clinical Operations activities.

• Plan and manage logistics, infrastructure, and resources related to FSP services to align with Client needs, timelines, and deliverables.

• Collaborate with Clients to implement and operationalize both short- and long-term strategies.

• Develop and manage Communication and Escalation plans and processes as necessary.

• Supervise Client Governance as required and prepare/present at meetings when applicable.

• Oversee performance management of staff supporting contracted FSP activities, working with FSP Clinical Operations Management to ensure staff are technically competent and able to meet Client expectations and deliverables.

• Ensure compliance with Client Key Performance Indicators (KPIs) by utilizing appropriate tools and systems to collect, track, and analyze relevant data.

• Lead Client-specific FSP meetings with the internal program team, ensuring that contractual obligations related to FSP Clinical Operations activities are consistently met and monitored.

• Manage and/or oversee issue escalation and resolution, including the development of Corrective and Preventive Actions (CAPA) when necessary.

• Manage and supervise FSP Clinical Operations functional and associated management staff based on Client structure and services.

• Coordinate and oversee the resourcing process, including hiring, selection, and onboarding/offboarding of staff, which may involve developing interview tools and conducting interviews with candidates.

⛳️ Requirements

• A minimum of 5+ years of experience in FSP Clinical Operations, with at least 3 years in a line management role.

• Direct experience with the Full Hybrid FSP Flex Model and Staff Augmentation, including delivery oversight and resourcing responsibilities across hybrid FSP Flex Monitoring models.

• Proven experience with FSP Resourcing Projections, Billing, and Financial Tracking, including workforce forecasting, billing processes, and financial oversight in an FSP context.

• Comprehensive understanding of the overall drug development process and clinical trial operations, along with a thorough knowledge of local regulations (e.g., FDA, EMA) and ICH/GCP guidelines.

• Demonstrated experience in applying regional talent acquisition, labor practices, retention strategies, and cultural differences as applicable.

• Previous experience in a remote office environment, managing remote staff independently while effectively overseeing and leading a team in a matrix organization.

• Experience in customer service and the FSP outsourcing model with demonstrated skills in managing and forecasting resource allocation.

🏝️ Benefits

• Health insurance

• 401(k) matching

• Flexible working hours

• Paid time off

• Professional development opportunities