SummaryThe 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.
Questions and Application ProcessIf interested, please apply and send your CV to [email protected]. All inquiries are treated confidentially.
ARTBIO does not accept unsolicited resumes from external agencies or recruiters. Submission of a resume without a prior written agreement does not create any express or implied contract between ARTBIO and the agency. ARTBIO will not pay any fees related to unsolicited resumes. 
