Associate Director, Clinical Trial Lead – Clinical Operations

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

📋 Description

• Lead the planning, execution, management, and delivery of designated regional and global clinical trials, spanning from protocol development to study conduct, closeout, analysis, and reporting.

• Provide operational leadership and oversight for study initiation, site activation, patient recruitment and enrollment, monitoring, protocol deviations, data review and cleaning, database lock readiness, and study closeout.

• Act as the primary operational liaison between internal cross-functional teams and external stakeholders, which include CROs, clinical sites, vendors, regulatory affairs, quality assurance, safety, data management, medical writing, translational research, clinical supply, and document management.

• Supervise the selection, onboarding, management, and performance of CROs and vendors, ensuring adherence to timelines, quality standards, contracts, and budgets.

• Cultivate relationships with investigational sites, investigators, study coordinators, monitors, and vendor partners.

• Develop, author, review, and approve trial documentation and operational plans, such as protocols, amendments, informed consent forms, study manuals, study plans, regulatory responses, and clinical study reports.

• Manage study budgets, forecasts, work orders, change orders, and financial performance metrics.

• Monitor study progress utilizing project management methodologies and operational metrics; identify risks and execute mitigation strategies.

• Promote operational innovation and process enhancements, including remote monitoring and clinical supply management.

• Ensure compliance with ICH-GCP, relevant regulations, and company SOPs; oversee quality issues, CAPAs, inspection readiness, audits, and regulatory inspections.

• Perform retained in-house operational tasks as necessary.

• Mentor, develop, and/or directly manage In-house CRAs, contingent workers, and other assigned personnel.

• Contribute to departmental initiatives, ongoing improvement, and the development or revision of clinical operations SOPs.

⛳️ Requirements

• BA or BS degree in a scientific or healthcare-related field is required.

• 8–10+ years of clinical research experience, featuring significant global clinical trial management experience in biotechnology or pharmaceutical companies.

• Demonstrated leadership of complex clinical studies, including budget management, timelines, vendor coordination, resource allocation, and risk management.

• Extensive experience in managing CROs, external vendors, and cross-functional teams within a matrix environment.

• Strong understanding of clinical trial operations, drug development processes, ICH-GCP, regulatory obligations, and inspection readiness.

• Experience across both early- and late-phase clinical development.

• Comprehensive knowledge of matrix management involving regulatory affairs, data management, safety/pharmacovigilance, medical monitoring, biostatistics, clinical supply, and medical writing.

• Ability to drive operational excellence, navigate complex challenges, and influence stakeholders at all levels.

• Exceptional leadership, project management, communication, and organizational abilities.

• Willingness to travel up to 10% as needed.

• Experience in cell/gene therapy or oncology is preferred.

• Must be authorized to work in the United States; visa sponsorship requirements will be addressed in the application process.

🏝️ Benefits

• Competitive benefits package

• Paid Time Off (PTO)

• Stock option plans

• Commitment to employee well-being and professional development

• Recognized as a Great Place to Work-Certified™ company