Sr. Director, IT Operations, Regulatory & Clinical Systems

Tris Pharma, Inc. () is a leading privately-owned US biopharmaceutical company focused on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have >150 US and International patents and market several branded ADHD products in the US. We also license our products in the US and ex-US markets. Our robust pipeline of innovative products employing our proprietary science and technology spans neuroscience and other therapeutic categories.

Our science and technology make us unique, but our team members set us apart; they're the engine fueling Tris' passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company’s success. Equally important is how we interact on a daily basis. We believe in each other and in respectful, open and honest communication to help support individual and team success.

This is a strategic technology leader and trusted business partner responsible for defining and executing the digital, data, and applications strategy across pharmaceutical operations, regulatory affairs, and clinical development. The role partners with senior functional leaders to translate business priorities into integrated technology roadmaps that improve patient and product outcomes, operational performance, compliance, data integrity, and organizational agility.

The incumbent provides enterprise leadership for systems and capabilities supporting manufacturing and supply operations, regulatory information management, and clinical research. This includes ERP and material requirements planning (MRP), manufacturing execution and batch management, computerized maintenance management systems (CMMS), shop-floor and warehouse technologies, quality and laboratory integrations, electronic document and regulatory information management, product registration and submission management, clinical trial management, electronic data capture and clinical data management, safety integrations, and clinical analytics.

The Senior Director establishes scalable platforms, governance, and data foundations and applies analytics, automation, generative AI, and agentic AI to transform business processes while maintaining appropriate GxP, privacy, cybersecurity, validation, and human-oversight controls.

• Serve as senior IT business partner to Operations, Manufacturing, Supply Chain, Engineering, Regulatory Affairs, Clinical Development, Quality, and related leadership teams; participate in functional planning, identify technology-enabled opportunities, and ensure IT investments are aligned with enterprise strategy, product priorities, compliance obligations, and measurable business outcomes.
• Develop and maintain multi-year digital and applications roadmaps for Operations, Regulatory, and Clinical functions, including, but not limited to: target capabilities, platform rationalization, integration strategy, data architecture, cybersecurity, lifecycle management, etc.
• Lead Operations systems portfolio supporting ERP and MRP, production planning and scheduling, procurement and inventory, warehouse management and scanning, manufacturing execution, electronic batch records and batch management, recipe and master-data management, CMMS and asset reliability, plant maintenance, shop-floor automation, equipment and historian interfaces, labeling, serialization, packaging, and operational performance management.
• Lead the Regulatory systems portfolio supporting regulated document and content management, authoring and collaboration, regulatory information management, product registration and…