Senior Director, Clinical Operations

Summary

The Senior Director of Clinical Operationsoverseesall aspects of clinical trial execution, including start-up, monitoring, and close-out activities. This key role 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, 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.
• Develop 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.
• Hire 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 oncology clinical trials.
  
  
  

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.
  
  
  

About Us

ARTBIO is a clinical-stage radiopharmaceutical company redefining cancer care by creating a new class of alpha radioligand therapies (ARTs). The unique ARTBIO approach selects the optimal alpha-precursor isotope (212Pb) and tumor-specific targets to create therapeutics with the potential for highest efficacy and safety. The company's AlphaDirect technology, a first-of-its-kind 212Pb isolation method, enables a distributed manufacturing approach for the reliable production and delivery of ARTs. ARTBIO is advancing multiple pipeline programs with lead program AB001 currently in first in human trials. ARTBIO is shaped by a long-standing scientific legacy with nearly a century of pioneering work in radiation therapy conducted at the University of Oslo and Norway’s Radium Hospital. For more information, visit www.artbio.com, and follow us on LinkedIn and Twitter.

As an emerging, global biotech with locations in Boston, Massachusetts, Basel, Switzerland, London, England and Oslo, Norway, we take advantage of diverse scientific depth and insights which makes ARTBIO a unique place to work. We are driven by a desire to do better for cancer patients, lowering the burden of toleration and safety while at the same time raising the bar on clinical efficacy and duration.

EEO Statement

ARTBIO is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. If you have a disability or special need that requires accommodation, please let us know.