Chief Architect

Instem•Morrisville, NC

5d•Hybrid

About The Position

The Chief Architect will own the technical vision and architectural integrity of d-wise’s clinical technology platform, reporting to the President of d-wise. The role defines architectural direction for the evolution of statistical computing environment (SCE) platforms, ensuring they are scalable, secure, interoperable, reliable, and compliant with GxP and 21 CFR Part 11 expectations. It also establishes guardrails for responsible AI/ML use in regulated software. This is a newly created, influential technical leadership position at the intersection of clinical technology, cloud architecture, statistical computing, and AI. The successful candidate may work remotely or on a hybrid basis, reporting into an office in Pennsylvania or North Carolina. Hybrid workers are expected to work in the office two days per week. The position is part of a friendly, solutions-focused environment within a global business of over 400 people. The company describes its culture as high-performance and flexible, encouraging ownership, professional growth, idea-sharing, and meaningful impact.

Requirements

12 or more years of software engineering experience, including 5 or more years in enterprise or platform architecture.
Proven experience in regulated environments such as life sciences, clinical, healthcare, or similar settings.
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, ideally in a regulated or validated environment, including governance and risk controls.
Strong written and verbal communication skills, with the ability to influence without relying on line authority.

Nice To Haves

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 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 safely and scalably incorporating AI/ML and generative AI into the platform, 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 built into AI capabilities from the start; 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, considering data-handling obligations across multiple jurisdictions and obtaining 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 technical voice with customers, auditors, and partners.
Lead technical due diligence on vendors, partnerships, and acquisitions.