Associate Director, IT Regulatory, Clinical, and Enterprise Systems
Core
Lead digital processes and IT systems for Clinical Operations, Regulatory, and Supply Chain Planning to enable commercialization of radiopharmaceutical therapies.
Role type
Senior IT Director (Regulatory/Clinical Systems)
Builds
Regulated digital solutions, service level management, and long-term technology roadmaps for a biotech.
Domain
Biotechnology / Radiopharmaceuticals / Regulated IT
Required skills
IT leadership in cGMP/Radiopharmaceutical environments, budget management, strategic roadmap planning, vendor management, risk-based validation, AI application for team execution
Preferred skills
Experience with clinical site portals, RIM, supply chain planning systems, multi-disciplinary team leadership
Technologies
Clinical site portals, RIM, supply chain planning systems, AI tools
Responsibilities
Ensure continuous operation of regulated digital solutions; Deliver service level management and disaster recovery; Align digital roadmap to business outcomes; Lead indirect reports and service providers; Partner with functional leaders on process automation; Provide IT leadership for regulatory inspection readiness; Manage new demand and evolve digital solutions; Identify key technology trends; Participate in high-level strategic communications; Develop long-term technology roadmaps