Associate Site Activation Director

The Associate Site Activation Director is responsible for leading the strategic, operational, and financial delivery of site activation activities across assigned clinical programs, regions, and customer engagements.

This role provides leadership and oversight for site identification and selection, regulatory and ethics approvals, site contracting, and activation activities to ensure studies are initiated efficiently, compliantly, and in alignment with customer expectations.

Essential Functions

Strategic Site Activation Leadership

• Provide strategic leadership for the planning, execution, and oversight of global and regional site activation activities, ensuring delivery against timeline, quality, budget, and customer expectations.
• Lead site activation strategy development from pre-award through site activation and lifecycle maintenance, identifying opportunities to accelerate startup performance and reduce study activation timelines.
• Oversee study startup delivery across one or more regions comprising multiple countries, ensuring alignment with project scope, customer requirements, and operational objectives.
• Serve as a senior escalation point for complex startup challenges, providing strategic solutions and driving issue resolution.
• Partner with global study teams to proactively identify risks, assess impact, and implement mitigation plans to support successful project delivery.

Operational Delivery & Study Execution

• Develop, implement, and oversee Site Activation Management Plans aligned with project strategy, Scope of Work, and contractual commitments.
• Ensure execution of startup activities in compliance with ICH-GCP, applicable regulatory requirements, study protocols, sponsor expectations, and company quality standards.
• Drive operational excellence through effective oversight of study approvals, regulatory submissions, ethics review processes, contract negotiations, and essential document management.
• Monitor project performance through established metrics, timelines, key performance indicators, and financial measures to ensure successful delivery.
• Ensure accurate maintenance of startup systems, databases, forecasting tools, project plans, and reporting platforms.

Regulatory Strategy & Risk Management

• Provide strategic guidance on regulatory pathways, submission requirements, ethics approvals, and country-specific startup requirements.
• Evaluate evolving regulatory landscapes and leverage regulatory intelligence to optimize startup strategies and execution plans.
• Identify regulatory complexities and operational barriers, developing innovative and practical solutions that support both business development and study delivery objectives.
• Lead risk assessment and mitigation activities, proactively identifying critical path challenges and implementing resolution strategies.

Financial & Business Leadership

• Maintain accountability for site activation budgets, forecasts, and resource utilization across assigned studies and programs.
• Partner with Project Management, Finance, and Operational Leadership to ensure delivery remains aligned with contractual obligations and financial targets.
• Support proposal development, competitive bid responses, and bid defense activities by providing strategic startup expertise and operational insights.
• Evaluate operational performance and implement efficiencies that improve productivity, customer satisfaction, and financial outcomes.

Customer Engagement & Partnership Management

• Build and maintain trusted relationships with sponsors and strategic customers, serving as a senior advisor on startup strategy and operational execution.
• Lead customer-facing workstreams and partnership initiatives focused on improving startup performance, operational effectiveness, and service delivery.
• Participate in governance meetings, partnership reviews, and early engagement discussions, representing Global Site Activation as a strategic business partner.
• Deliver executive-level status updates, operational insights, and risk assessments to customers and internal leadership teams.

People Leadership & Talent Development

• Provide mentorship, coaching, and development support to Site Activation Managers and other startup professionals.
• Foster a culture of accountability, collaboration, innovation, and continuous improvement across the Global Site Activation organization.
• Support talent development initiatives, succession planning, and onboarding of new team members.
• Share subject matter expertise through presentations, training programs, and participation in industry forums and professional organizations.

Continuous Improvement & Organizational Impact

• Lead departmental and cross-functional initiatives that enhance startup processes, quality outcomes, and customer experience.
• Champion innovation and best practices within Global Site Activation, leveraging technology and data-driven insights to improve performance.
• Contribute to the development and implementation of operational standards, governance models, and process improvements.
• Influence organizational strategy by providing expertise and recommendations on startup operations, regulatory trends, and industry best practices.

Minimum Required Education & Experience

• Bachelor's Degree in Life Sciences, Health Sciences, Pharmacy, Nursing, or a related field, or an equivalent combination of education and experience.
• Minimum of 8 years of experience within clinical research, site activation, regulatory affairs, or clinical operations.
• Minimum of 5 years of leadership experience managing complex global or regional clinical trial startup activities.
• Demonstrated experience leading multinational studies and working across diverse regulatory environments.
• Proven experience serving in customer-facing roles and managing strategic stakeholder relationships.
• Experience supporting business development activities, proposals, and bid defense presentations.

Skills & Competencies

• Demonstrated ability to lead through influence in a complex global matrix organization.
• Strong strategic thinking and decision-making capabilities with a proven ability to balance operational execution and long-term business objectives.
• Ability to exercise sound judgment, take calculated risks, and drive resolution of highly complex issues.
• Advanced understanding of the global clinical trial environment and drug development process.
• Expert knowledge of ICH-GCP, global regulatory requirements, ethics review processes, and site activation methodologies.
• Excellent customer relationship management skills with a demonstrated ability to build trusted partnerships.
• Strong financial acumen with experience managing budgets, forecasts, scope changes, and operational performance metrics.
• Exceptional communication, negotiation, presentation, and stakeholder management skills.
• Demonstrated success managing multiple complex projects with competing priorities.
• Strong analytical and problem-solving skills with a proactive approach to risk identification and mitigation.