Sr. Director, IT Operations, Regulatory & Clinical Systems

Description

Tris Pharma, Inc. (www.trispharma.com) 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.

We have an immediate opening for a Senior Director, IT – Operations, Regulatory & Clinical Systems in our Monmouth Junction, NJ facility.

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.

ESSENTIAL FUNCTIONS:

• 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 license management, submission planning and publishing, health authority commitments and correspondence, etc.
• 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 that provide trusted cross-functional insight from development through commercialization and supply.
• 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 across strategic programs and production-critical services.
• Provide executive oversight for solution delivery and the full system lifecycle, including process redesign, requirements, architecture, configuration, etc.
• 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.

Requirements

• Bachelor’s degree in IT, Computer Science, Engineering, Life Sciences, Business or a related discipline and a minimum 12 years progressive experience in enterprise applications, digital transformation, data and analytics, or technology leadership (including minimum 5 years leading managers, teams or complex programs) in a pharmaceutical, biotechnology, medical device, or other regulated life-sciences environment. Equivalent combinations of education and relevant experience may be considered
• 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

Work Arrangements: We are a HYBRID work environment requiring local candidates to be able to work majority of week in our NJ office. Non-local candidates must be able to come into office multiple times a month.

Anticipated salary range: $210 to $240K/yr. Base salary offered is contingent on assessment of candidate’s education and experience level relative to requirements of the position and a review of related industry standards and internal equity.

Additional benefits: In addition to base salary, full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups.

Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer.