R&D Solutions Architect, Senior Manager

Takeda•Boston, MA

8h•Onsite

About The Position

The Solutions Architect, Senior Manager defines and drives end-to-end solution architecture for cross-functional R&D initiatives, with primary focus on clinical development, regulatory, and pharmacovigilance. You translate business needs into secure, scalable, and interoperable solution designs that enable study execution, evidence generation, submissions, and pharmacovigilance operations. You partner with Enterprise Architecture and R&D product and technology teams to align solutions to enterprise standards and roadmaps, and you strengthen the R&D data ecosystem by integrating foundational components that improve data quality, provenance/traceability, and governance across clinical, regulatory, and safety data. As a senior individual contributor, you lead architecture decisions in complex, regulated environments, influence stakeholders across functions, and mentor engineers and junior architects.

Requirements

Bachelor’s degree or equivalent experience (Master’s preferred).
5+ years in technology roles with progressive responsibility; experience in pharmaceutical/biotech or other regulated industries preferred.
Track record of delivering technology and process change end-to-end, balancing speed, quality, and risk.
Operates with high autonomy and sound judgment; able to lead through ambiguity and drive decisions without direct authority.
Strong communication, facilitation, and mentoring skills; able to raise the technical bar across teams.
Detail-oriented and quality-focused, with a bias toward pragmatic solutions that are secure, compliant, and supportable.
Experience with regulatory compliance and data governance in a healthcare/pharmaceutical context (clinical, regulatory, and/or safety).

Responsibilities

Define and advocate target architecture, architecture vision, and ways of working for R&D solutions spanning clinical development, regulatory, and pharmacovigilance.
Support solution evaluation and selection, including buy vs. build considerations, vendor/product fit assessments, and early-phase sizing and estimation.
Lead technical and solution design for assigned initiatives, from discovery through detailed design and delivery alignment.
Produce high-quality architecture artifacts, such as target-state and solution architecture, integration, and data flow designs, and support approval through enterprise and peer design reviews.
Ensure solutions align with architecture standards and principles, leveraging common platforms, shared services, and reusable patterns.
Provide architecture guidance to delivery teams and support organizations to help resolve design risks, technical debt, and alignment to IT and R&D strategies.
Develop solution architecture grounded in R&D constraints, including regulated environments, validation needs, privacy, interoperability, and ecosystem dependencies.
Architect information delivery, advanced analytics, and BI capabilities that enable R&D insights and reporting for clinical, regulatory, and safety outcomes.
Stay current on emerging trends in clinical research and development, regulatory technology, pharmacovigilance, data, and AI/ML, and translate them into practical, compliant architecture recommendations.
Ensure compliance with applicable privacy, security, and data protection requirements, and promote auditability and traceability by design.