Sr. Director, IT Operations, Regulatory & Clinical Systems

Tris Pharma•Monmouth Junction, NJ

1d•Hybrid

About The Position

Tris Pharma, Inc. is a leading privately-owned US biopharmaceutical company focused on development and commercialization of innovative medicines. This role 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 a wide range of systems such as ERP, MRP, MES, CMMS, regulatory information management, clinical trial management, and clinical data management. The Senior Director establishes scalable platforms, governance, and data foundations and applies advanced technologies like AI to transform business processes while maintaining GxP, privacy, cybersecurity, and validation controls.

Requirements

Bachelor’s degree in IT, Computer Science, Engineering, Life Sciences, Business or a related discipline
A minimum of 12 years progressive experience in enterprise applications, digital transformation, data and analytics, or technology leadership
Minimum of 5 years leading managers, teams, or complex programs
Experience in a pharmaceutical, biotechnology, medical device, or other regulated life-sciences environment
Demonstrated success shaping business strategy and translating Operations, Regulatory, and Clinical priorities
Broad knowledge of life-sciences processes and systems across manufacturing and supply operations, regulatory affairs, and clinical development
Strong understanding of GxP, computer system validation and assurance, 21 CFR Part 11 and electronic records/electronic signatures, data integrity, privacy, records retention, audit and inspection readiness, change control, cybersecurity, and risk-based quality practices
Ability to advise senior leaders, challenge constructively, align diverse stakeholders, and simplify complex decisions
Strong enterprise architecture and integration perspective across cloud, SaaS, on-premises, plant-floor, laboratory, partner, and data platforms
Proven ability to establish governed data and analytics capabilities, including data platforms, data products, quality and lineage, semantic models, self-service analytics, operational and regulatory dashboards, predictive methods, and cross-functional performance measures
Practical understanding of AI strategy and responsible adoption

Responsibilities

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 target capabilities, platform rationalization, integration strategy, data architecture, cybersecurity, and lifecycle management.
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 license management, submission planning and publishing, health authority commitments and correspondence.
Lead Clinical systems portfolio supporting clinical trial management (CTMS), electronic data capture (EDC), clinical data management, electronic trial master file (eTMF), study start-up, randomization and trial supply management, patient and site engagement technologies, electronic consent and clinical outcome assessments, medical coding, statistical and data-review environments, safety and pharmacovigilance integrations, and clinical data standards, interoperability, and analytics.
Establish a shared data and analytics strategy across the three domains, including governed data products, master and reference data, metadata, data quality, lineage, semantic models, dashboards, predictive analytics, process intelligence, and AI-ready data foundations.
Sponsor responsible adoption of automation, advanced analytics, generative AI, and agentic AI, including use-case prioritization, architecture patterns, knowledge agents, intelligent workflow, exception detection, forecasting, decision support, content acceleration, and human-in-the-loop controls.
Own portfolio governance and investment planning for assigned domains, including demand management, business cases, prioritization, budgeting, resource planning, delivery oversight, benefits tracking, risk management, executive reporting, and transparent resolution of competing priorities.
Provide executive oversight for solution delivery and the full system lifecycle, including process redesign, requirements, architecture, and configuration.
Partner with Enterprise Architecture, Data and Analytics, Cybersecurity, Infrastructure, Quality, Privacy, Legal, and Records Management to ensure platforms and integrations conform to enterprise standards and applicable requirements for GxP, data integrity, privacy, electronic records and signatures, retention, auditability, resilience, disaster recovery, and third-party risk.