Director, IRT Systems Job at Kailera Therapeutics (Waltham)

Job Description

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.

Job Responsibility

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

Requirements

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
Bachelor's degree or equivalent experience

Nice to have

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
Advanced degree or PharmD

What we offer

comprehensive health coverage
flexible time off
paid holidays
year-end shutdown
monthly wellness stipend
generous 401(k) match
tuition reimbursement
commuter benefits
disability and life insurance
annual bonus opportunities
equity grants

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Director, IRT Systems

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