Associate Director, Country & Site Operations

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

📋 Description

• Oversee a team of 20-25 FSP personnel assigned to the clinical portfolio.

• Direct resource forecasting, assignment, and prioritization to meet regional delivery requirements, portfolio demand, and commitments outlined in the annual operating plan.

• Assist in forecasting FSP budgets and providing financial oversight.

• Create, enhance, and enforce role-specific processes, guidelines, and quality standards.

• Develop and implement training and onboarding initiatives in collaboration with FSP vendors, CSO leaders, and cross-functional partners.

• Manage the onboarding and offboarding processes for FSP resources.

• Act as a representative of CSO in FSP vendor governance, oversight, and performance management meetings.

• Track, analyze, and report on FSP role performance metrics, quality indicators, workload trends, and delivery risks.

• Collaborate with regional leaders, study teams, Medical, Quality, and other stakeholders to align objectives and enhance site-centric execution.

• Promote ongoing improvements to the FSP operating model to enhance scalability, efficiency, clarity of roles, quality, and cost-effectiveness.

⛳️ Requirements

• Bachelor's degree in a scientific field; an advanced degree is preferred.

• A minimum of 8 years of experience in clinical research, clinical operations, country/site operations, or project management.

• Required experience in managing resources, vendors, and cross-functional stakeholders.

• Demonstrated ability to lead and supervise FSP staff, including resource planning, training, performance management, and workload prioritization.

• Comprehensive understanding of country and site operations, clinical trial execution, and essential business drivers.

• Extensive cross-functional knowledge of drug development and expertise in clinical trial phases I–IV, including country activation, site engagement, study conduct, and inspection readiness.

• Effective line management and mentoring capabilities.

• Profound knowledge of GCP, ICH guidelines, regulatory requirements, and quality expectations for global clinical development.

• Strong project management skills, including risk assessment, contingency planning, vendor oversight, and issue escalation within an insourced FSP model.

• A collaborative, site-centric approach with the ability to engage effectively with both internal and external stakeholders.

🏝️ Benefits

• Medical, Dental, Vision, & Life insurances

• Fitness & Wellness programs including a fitness reimbursement

• Short- and Long-Term Disability insurance

• A minimum of 15 days of paid vacation

• End-of-year shutdown time off (Dec 26-Dec 31)

• Up to 12 company-paid holidays

• 3 paid days off for Personal Significance

• 80 hours of sick time per calendar year

• Paid Maternity and Parental Leave benefit

• 401(k) program participation with company-matched contributions

• Employee stock purchase plan

• Tuition reimbursement of up to $10,000 per calendar year

• Participation in Employee Resource Groups

• Short-term and long-term incentives, including cash bonuses and equity incentive opportunities