Associate Director, Clinical Business Operations – IRT Systems

Are you ready to help transform hope into reality?

We’re seeking an experienced IRT Project Manager to join our Clinical Business Operations team. In this role, you’ll lead the setup, testing, and ongoing management of Interactive Response Technology (IRT) systems across clinical studies (Phases I–IV), ensuring safety, compliance, and supply chain readiness for investigational products.

What You'll Do:

• Serve as the IRT subject matter expert and lead cross-functional setup and maintenance of IRT systems.
• Ensure IRT systems align with study protocols and GxP regulations.
• Act as a key stakeholder in vendor selection and ongoing IRT supplier oversight.
• Support clinical study protocol development—particularly around randomization, blinding, and product attributes.
• Coordinate user acceptance testing (UAT), script review, and execution with study teams.
• Implement clinical supply strategies within IRT in collaboration with Investigational Supply Operations (ISO).
• Provide IMP drug handling training to internal teams and external investigational sites.
• Support audits, issue resolution, and performance monitoring of IRT vendors.
• Contribute to building IRT standards and efficiencies across clinical studies.
• Ensure compliance with SOPs, GCP, ICH guidelines, and ethical/legal standards.

What You Bring:

• Bachelor’s degree (required); Pharmacist degree preferred.
• 8+ years of experience in clinical development, with deep IRT and drug development expertise.
• Proven success in project management, vendor oversight, and cross-functional collaboration.
• In-depth knowledge of GCP and GMP.
• Strong communication and presentation skills.
• Passion for excellence and alignment with core values like urgency, thoughtfulness, and patient-first mindset.