Vice President, Clinical Development Operations

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Tempus AI

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2015

🧬 Biotechnology

🤖 Artificial Intelligence

Healthcare • Biotechnology • Artificial Intelligence

Tempus AI is an advanced healthcare technology company that specializes in precision medicine through the use of AI and genomic profiling. The company provides innovative solutions across various medical fields, including oncology, cardiology, neurology, and psychiatry. Tempus enables healthcare providers to make informed treatment decisions by integrating real-world data, clinical trial matching, and algorithmic testing to improve patient outcomes and accelerate drug development.

📋 Description

• Hold primary accountability for the operational planning, management, and execution of clinical trials designed for clinical evidence generation. • Drive performance against key trial metrics, including site activation, patient enrollment, data quality, budget adherence, and alignment with corporate goals and regulatory requirements. • Develop and implement optimized operational strategies to enhance trial efficiency, reduce complexity, and accelerate data delivery timelines. • Actively participate in budget planning, financial forecasting, and resource allocation for the evidence generation operations unit to ensure optimal performance. • 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. • Interact closely and establish seamless workflows with cross-functional leaders to ensure that clinical trial data from all sources is accurately captured and reconciled. • Lead, mentor, and develop a high-performing operations team capable of managing a focused portfolio of clinical evidence generation studies. • 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. • Ensure all evidence-generation trial activities are conducted in strict accordance with Good Clinical Practice (GCP), ICH guidelines, and global regulatory standards. • Maintain a constant state of inspection readiness for all evidence-generation clinical trials and support senior leadership during regulatory authority inspections (e.g., FDA).

🎯 Requirements

• Bachelor’s degree in a scientific, life sciences, or healthcare discipline required; advanced degree (MS, PhD, PharmD) preferred. • 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.

🏖️ Benefits

• We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.