Position Summary

The Manager, Solution Architecture – Clinical R&D IT designs and coordinates secure, scalable, compliant technology solutions for clinical data, statistical computing, research, and analytics platforms. Working with Clinical Data Operations, Biostatistics, Statistical Programming, Translational Medicine, Data Science, and IT partners, the role translates business needs into fit-for-purpose solutions that support clinical development and scientific discovery.

The manager coordinates platform lifecycle activities, including architecture, roadmap execution, vendor delivery, cloud and infrastructure changes, system validation, and operational readiness. The role identifies and escalates risks, recommends practical improvements, and supports platform reliability, regulatory compliance, cybersecurity, and business continuity.

Key Responsibilities

Architecture Strategy and Solution Design

· Apply and help maintain Clinical R&D technology architecture principles, patterns, and standards.

· Design integrated, end-to-end solutions supporting Clinical Operations, Clinical Data Management, Biostatistics, Statistical Programming, Data Science, Translational Sciences, and related functions.

· Contribute to current-state and future-state architecture documentation and maintain assigned roadmap components.

· Evaluate emerging technologies, cloud services, and modernization opportunities, and recommend practical options.

· Confirm that proposed solutions align with enterprise architecture, cybersecurity, infrastructure, and data standards; escalate exceptions for approval.

Clinical Computing Platform Management

· Support the platform owner and serve as a solution architecture resource for assigned Clinical R&D platforms.

· Coordinate assigned roadmap activities, lifecycle tasks, upgrades, integrations, and decommissioning plans.

· Support platform governance, operational effectiveness, and alignment with agreed business priorities.

· Monitor platform reliability, scalability, sustainability, and business value; coordinate corrective actions when needed.

Cloud and Infrastructure Architecture

· Design and support implementation of cloud, hybrid, and on-premises solutions.

· Partner with Infrastructure and Cybersecurity teams on hosting, networking, identity and access management, disaster recovery, performance, and resilience requirements.

· Serve as a technical contact for infrastructure- and security-related platform decisions.

· Recommend cloud optimization and resilience improvements for assigned platforms.

Clinical Data and Analytics Architecture

· Design and document data architecture, integration patterns, and information lifecycle requirements in alignment with established standards.

· Support clinical data platforms, analytics environments, statistical computing, AI and machine learning initiatives, and computational research environments.

· Improve interoperability and enable approved analytics capabilities across Clinical R&D.

Compliance, Validation, and Risk Management

· Coordinate compliance and validation activities for assigned platforms, including Good Clinical Practice (GCP), computer system validation (CSV), data privacy, cybersecurity, and software development lifecycle requirements.

· Partner with Quality Assurance, validation, and Security teams to maintain inspection- and audit-ready systems.

· Identify, document, escalate, and support mitigation of technical, operational, compliance, data integrity, and cybersecurity risks.

· Promote traceability and validated system management practices throughout the platform lifecycle.

Vendor and Managed Service Oversight

· Coordinate technical activities with vendors, cloud providers, consulting partners, and managed service providers.

· Review and provide recommendations on solution designs, proposals, implementation approaches, and technical deliverables.

· Ensure vendor-delivered solutions meet quality, compliance, security, and architecture standards.

· Monitor service levels, delivery quality, cost-effectiveness, and improvement actions; escalate issues as needed.

Program and Project Delivery

· Manage assigned technical workstreams for Clinical R&D computing implementations, upgrades, migrations, and modernization initiatives.

· Translate business requirements into scalable technical solutions and executable delivery plans.

· Document and communicate dependencies, risks, resource requirements, costs, and technical constraints.

· Participate in architecture reviews, change advisory processes, validation activities, and operational readiness assessments.

Technical Leadership and Collaboration

· Provide technical guidance to engineers, vendors, managed service providers, and support teams.

· Collaborate with business, technology delivery, and platform operations teams to support aligned execution.

· Prepare and communicate solution options, technical risks, recommendations, and status updates to IT and business stakeholders.

· Provide input to Clinical R&D technology roadmaps, governance activities, and investment planning.

Required Qualifications

· Bachelor's degree in computer science, information technology, engineering, life sciences, or a related field.

· Relevant experience in solution architecture, platform architecture, enterprise applications, or clinical and scientific computing within a regulated environment.

· Experience designing and implementing cloud-based, hybrid, and integrated enterprise solutions.

· Strong knowledge of clinical research processes, data management, statistical computing, and regulated system lifecycle practices.

· Experience applying Good Practice (GxP), Good Clinical Practice (GCP), computer system validation (CSV), data integrity, privacy, cybersecurity, and audit-readiness requirements.

· Ability to manage assigned technology initiatives, coordinate vendors, and collaborate effectively with cross-functional stakeholders.

· Strong analytical, communication, planning, problem-solving, and stakeholder presentation skills.

Preferred Qualifications

· Advanced degree in a relevant technical, scientific, or business discipline.

· Experience with Amazon Web Services (AWS), clinical data platforms, SAS or SAS Viya, statistical computing environments, data engineering, artificial intelligence and machine learning (AI/ML) platforms, and modern analytics technologies.

· Experience supporting or managing technical workstreams for platform internalization, cloud transformation, application modernization, or large-scale migrations.

· Familiarity with enterprise architecture frameworks, agile delivery, development, security, and operations (DevSecOps), and IT service management practices.

· Experience in the pharmaceutical, biotechnology, or life sciences industry supporting global Clinical R&D organizations.

This role is hybrid in Nutley NJ requiring 3 days in offer per week (Tuesday, Wednesday and Thursday)

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