Note: The job is a remote job and is open to candidates in USA. Tempus AI is focused on advancing the healthcare industry through precision medicine and AI technology. The Vice President, Clinical Development Operations is responsible for providing strategic leadership and operational oversight for clinical studies, ensuring high-quality execution and compliance with regulatory standards.
Responsibilities
- Overall Study Conduct: Hold primary accountability for the operational planning, management, and execution of clinical trials designed for clinical evidence generation
- Metric-Driven Performance: Drive performance against key trial metrics, including site activation, patient enrollment, data quality, budget adherence, and alignment with corporate goals and regulatory requirements
- Operational Excellence: Develop and implement optimized operational strategies to enhance trial efficiency, reduce complexity, and accelerate data delivery timelines
- Resource & Budget Management: Actively participate in budget planning, financial forecasting, and resource allocation for the evidence generation operations unit to ensure optimal performance
- Data Integrity & Flow: Collaborate closely with Biostatistics and Data Management teams to ensure the timely, accurate, and high-quality flow of trial data into the clinical database, facilitating efficient data cleaning, analysis, and database lock
- Cross-Functional Collaboration: Interact closely and establish seamless workflows with cross-functional leaders to ensure that clinical trial data from all sources is accurately captured and reconciled
- Team Leadership: Lead, mentor, and develop a high-performing operations team capable of managing a focused portfolio of clinical evidence generation studies
- Stakeholder Alignment: Serve as the primary operational leader for evidence generation trial conduct, ensuring tight alignment and communication with Clinical Development, Regulatory Affairs, Project Management, and other key stakeholders
- GCP Compliance: Ensure all evidence-generation trial activities are conducted in strict accordance with Good Clinical Practice (GCP), ICH guidelines, and global regulatory standards
- Inspection Readiness: Maintain a constant state of inspection readiness for all evidence-generation clinical trials and support senior leadership during regulatory authority inspections (e.g., FDA)
Skills
- Bachelor's degree in a scientific, life sciences, or healthcare discipline required
- 13+ years of progressive clinical trial operations experience within pharma, biotech, or medical device sectors, with a distinct focus on managing trials for clinical evidence generation
- 5+ years managing and building high-performing clinical operations teams
- Deep, demonstrable knowledge of GCP, ICH guidelines, and experience defending clinical data/sites during regulatory authority inspections (e.g., FDA)
- Proven track record of partnering successfully with Biostatistics, Data Management, and Medical Directors to achieve timely database locks
- Advanced degree (MS, PhD, PharmD)
Company Overview
Company H1B Sponsorship