Summary
The Senior Director of Clinical Operations oversees all aspects of clinical trial execution, including start-up, monitoring, and close-out activities for all ARTBIO programs. This key role leads the clinical operations team and ensures that the company achieves study goals and objectives while maintaining high-quality clinical data and study integrity. The Senior Director of Clinical Operations collaborates closely with cross-functional teams, including clinical development, project management, regulatory, quality, finance, and translational and discovery research, to drive the successful execution of clinical study plans.
Main Duties and Responsibilities
Establish clear standards and expectations for the accurate, timely execution of clinical trials and the operations teams supporting them.
Oversee study operational plans and execution from concept through close out and CSR writing, including site and vendor selection, data management, pharmacovigilance operations, imaging and laboratory assessments, and regulatory activities.
Assess and provide input into schedule of activities of study protocols from an operational and feasibility perspective.
Review DSUR, study protocols, annual reports, and IB submissions for accuracy and alignment to compound strategy.
Lead and execute clinical operations strategies and enrollment plans in close collaboration with internal stakeholders, alliance partners, and Clinical Research Organizations (CROs).
Manage CRO(s) performance to ensure adherence to the scope of work within timelines and budget at an overall study level.
Build out an in-house CRA team for Phase 1 study monitoring.
Work with the existing clinical trial managers and clinical scientists to ensure trial delivery and success.
Collaborate with the manufacturing and logistics teams for alignment on drug product delivery to clinical studies.
Work closely with the CMO to develop the global clinical operations budget with a focus on operational excellence, cost efficiency, and quality.
Proactively assess potential risks to clinical studies and propose mitigation plans.
Qualifications & Experience Required
Bachelor’s, Master's, or higher qualification in life sciences or nursing.
Minimum of 7 years of experience in clinical development, including at least 5 years in clinical operations of Phase 1 or 2 oncology clinical studies, with at least 2 of the years in a clinical trial or project management leadership role.
Remote flexibility with up to 25% travel within the United States.
Knowledge, Skills & Abilities Required
Cross-functional understanding and technical knowledge of drug development processes and clinical trial methodology.
Thorough knowledge and understanding of Good Clinical Practices, ICH Guidelines, and applicable international regulations and guidelines.
Strong project management/organizational skills.
Excellent technical experience with MS applications (e.g., MS Project, Word, Excel).
Experience with study tools, including CTMS, eTMF, Medidata RAVE, and other EDC systems.
