What You’ll Do:

The Director, IRT Systems will be responsible for the initiation, execution, maintenance and close out of IRT systems throughout Kailera’s portfolio. This position will track and maintain timelines for all Go Live and Close Out activities, adhere to all GxP requirements as well as maintain and organize all required documents for filings. This position will be unblinded, and part of the Global Supply Chain department, reporting to the Senior Director, Global Supply Chain.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Responsibilities:

• Liaison between Global Supply Chain and Business Operations to gather requirements and timing for quotes through go live dates
• Expert in interpreting protocols and study schemes to ensure IRT builds are properly quoted and executed
• IRT system design and overnight including management of study drug kit lists (Dummy and Live)
• Collaborates cross functionally with clinical development, clinical operations, CMC, and statistics, focusing on randomization schema, stratification, and site & subject management, to ensure all requirements across the groups are met within the system
• Vendor management: Serves as primary contact for IRT vendors internally and escalates requests and support as needed
• Leads project documentation, test scripts, eTMF filing and performance metrics from study start to closeout for company portfolio
• Risk management and continuous improvement to ensure IRT is performing as needed
• Supports day to day activities for ad hoc resolutions, process optimizations and enhancements as needed
• Actively participates in clinical study meetings, provide updates on system functionality and provides training as needed
• Proactively reviews requirements to identify potential risks and build risk mitigation strategies
• All other duties as required

Required Qualifications:

• 10+ years of experience managing end-to-end activities for IRT system builds and close outs
• Ability to interpret clinical protocols and provide system-based solutions for IRT optimization
• Profound knowledge of various drug presentations and formulations
• Excellent project management and organizational skills
• Excellent communication skills and ability to present and articulate system needs clearly and effectively
• Successful management and deployment of kit list builds (Dummy and Live) across Ph I – Ph III clinical studies for both open label and blinded needs
• Ability to work cross-functionally and prioritize activities while maintaining all requisite timelines for study needs
• Thrive in a fast-paced environment
• Passion for continuous improvement and innovation to bring study drug to patients quickly and effectively

Preferred Qualifications:

• Worked with complex study designs including up/down titrations across various drug product formulations.
• Successfully manage IRT build and closeout of clinical studies across 3+ IRT systems

 

Education:

• Bachelor's degree or equivalent experience
• Advanced degree or PharmD preferred