Chief Architect

Instem•Morrisville, NC

6d•Hybrid

About The Position

The Chief Architect will own the technical vision and architectural integrity of d-wise’s clinical technology platform. This is a new, influential technical leadership position at the intersection of clinical technology, cloud architecture, statistical computing, and AI. The role defines the architectural direction for the company’s statistical computing environment (SCE) platforms while ensuring solutions remain scalable, secure, interoperable, reliable, and suitable for regulated life sciences environments. The Chief Architect reports to the President of d-wise and works across product, business, engineering, Quality, Regulatory, Legal, and Security functions. The role establishes architecture and AI/ML governance, guides interoperability and platform consolidation, and represents the technical organization with customers, auditors, and partners. The position may be performed on a hybrid or remote basis, reporting into an office in Pennsylvania or North Carolina; hybrid workers attend the office two days per week.

Requirements

12 or more years of experience in software engineering, including 5 or more years in enterprise or platform architecture.
Proven experience in regulated environments such as life sciences, clinical, healthcare, or similar.
Working knowledge of GxP, 21 CFR Part 11, computer system validation (CSV/CSA), and data integrity.
Experience designing cloud-native, multi-tenant SaaS platforms.
Demonstrated experience architecting production AI/ML or generative AI solutions, including governance and risk controls.
Strong written and verbal communication skills, with the ability to influence without relying on line authority.

Nice To Haves

Experience in a regulated or validated environment architecting production AI/ML or generative AI solutions.
Exposure to clinical or nonclinical data standards.
A relevant degree or certification, such as TOGAF or a cloud architecture certification.

Responsibilities

Define and maintain the target architecture and a multi-year technical roadmap aligned with product and business strategy.
Embed validation, audit trails, electronic records and signatures, data integrity (ALCOA+), and change control into architecture patterns in collaboration with Quality and Regulatory.
Establish architectural standards for AI/ML model lifecycle, explainability, data lineage, bias and performance monitoring, human oversight, and traceability; partner with Legal, Quality, and Security on responsible AI policy.
Define architecture for safe, scalable integration of AI/ML and generative AI capabilities, including reusable model-serving, data pipeline, and evaluation patterns.
Make build-versus-buy-versus-partner decisions for AI components and assess emerging AI technologies for suitability in regulated clinical workflows.
Ensure human oversight, validation evidence, and traceability are designed into AI-enabled workflows; engage the Architecture function under Instem’s governance framework when AI-embedded workflows or agents are proposed.
Chair the architecture review forum, maintain architecture decision records (ADRs), and manage technical debt and platform rationalisation.
Set secure-by-design and privacy-by-design principles, accounting for data-handling obligations that may apply across the UK, US, EU, and India, with specialist legal review where needed.
Guide standards-based data exchange and integration across products and customer ecosystems.
Mentor senior engineers, develop an architecture community of practice, and serve as a credible technical voice with customers, auditors, and partners.
Lead technical due diligence on vendors, partnerships, and acquisitions.
Deliver the stated first 12–18 month success measures: approved and communicated target architecture and roadmap; operating architecture governance with recorded and followed decisions; adopted, audit-ready AI/ML architectural standards; measurable platform consolidation progress; and zero critical architecture-related audit findings.