Chief Architect

Chief Architect Location: Hybrid/Remote: The successful candidate can work on a Hybrid/Remote basis, reporting into one of our offices located in Pennsylvania or North Carolina. Status: Permanent Package: Competitive Salary, Remote/Home Working (with one-off allowance), Flexible Working, (2 Days in the office for our Hybrid workers) Development Opportunity (Personal Technical), Medical Insurance, Dental Insurance, Vision Insurance, Life Insurance, Long Term Short-Term Disability Insurance, Generous 401K (matching) Plan, Flexible Spending Account, Health Savings Account, 15 Days' Vacation + Plus Public Holidays + Buy and Sell Scheme. d-wise, an Instem company, makes validated, compliant statistical computing simple — so clinical teams can focus on the science, not the infrastructure. We build and manage the SCE platforms that sit behind regulatory submissions, and our work directly enables the approvals that bring new medicines to patients. Reporting to the President, d-wise, you will own the technical vision and architectural integrity of the clinical technology platform. Ensure that what we build is scalable, secure, interoperable and compliant with GxP and 21 CFR Part 11 expectations. Set the guardrails for responsible AI/ML use in regulated software. Our Culture Work Environment. You’ll be part of a friendly, solutions-focused environment within a global business of over 400 people. Here, you’ll experience a high-performance culture balanced with genuine flexibility - we trust you to take ownership, deliver meaningful results, and work in a way that suits you. You’ll be encouraged to grow, share your ideas, and make a real impact. We’re passionate about creating a place where you can develop your skills, contribute confidently, and succeed in your career. Why join us as a Chief Architect? This is a brand new position within the d-wise team, it is a highly influential technical leadership role at the intersection of clinical technology, cloud architecture, statistical computing and AI. The Chief Architect will define the architectural direction that enables d-wise to continue evolving its SCE platforms while maintaining the validation, compliance, security and reliability expected within clinical development. What You’ll Be Doing • Architecture strategy: Define and maintain the target architecture and a multi-year technical roadmap aligned to product and business strategy. • Regulated by design: Embed validation, audit trails, electronic records and signatures, data integrity (ALCOA+) and change control into architecture patterns, working with Quality and Regulatory. • AI/ML governance: Establish architectural standards for model lifecycle, explainability, data lineage, bias and performance monitoring, human oversight and traceability. Partner with Legal, Quality and Security on responsible AI policy. • AI architecture and enablement: Define the architecture that lets AI/ML and generative AI capabilities be built into the platform safely and at scale, including reusable model-serving, data pipeline and evaluation patterns; build-vs-buy-vs-partner decisions for AI components; and assessment of emerging AI technologies for fit with regulated clinical workflows. Ensure human oversight, validation evidence and traceability are designed in from the start. Where AI-embedded workflows or agents are proposed, engage the Architecture function under Instem's governance framework. • Governance: Chair the architecture review forum, maintain architecture decision records (ADRs), and manage technical debt and platform rationalisation. • Security and privacy: Set secure-by-design and privacy-by-design principles, recognising that data handling obligations may apply across multiple jurisdictions (UK, US, EU, India), with specialist legal review where needed. • Interoperability: Guide standards-based data exchange and integration across products and customer ecosystems. • Technical leadership: Mentor senior engineers, grow an architecture community of practice, and act as a credible technical voice with customers, auditors and partners. • Evaluation: Lead technical due diligence on vendors, partnerships and acquisitions. What We’re Looking For • 12+ years in software engineering, including 5+ years in enterprise or platform architecture. • Proven experience in regulated environments (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, ideally in a regulated or validated environment, including governance and risk controls. • Strong written and verbal communication; able to influence without relying on line authority. • Preferred: exposure to clinical or nonclinical data standards; relevant degree or certification (e.g. TOGAF, cloud architecture). Success Measures (First 12–18 Months) • Target architecture and roadmap approved and communicated. • Architecture governance operating, with decisions recorded and followed. • AI/ML architectural standards adopted and audit-ready. • Reduced duplication and measurable progress on platform consolidation. • Zero critical architecture-related audit findings. Ready to Make a Difference? Join a team that values your perspective and supports your growth, while helping shape the future of life sciences. Apply now - we’d love to hear from you, and our Talent team will be in touch. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Instem stores and processes data using an Applicant Tracking System (ATS). 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