Company Information
Clinical Ink is the global life science company that brings data, technology, and patient science together to unlock clinical discovery. Our deep therapeutic-area expertise, coupled with Direct Data Capture, eCOA, eConsent, telehealth, neurocognitive testing, and digital biomarkers advancement, drive the industry standard for data precision and usher in a new generation of clinical trials. With offices in the United States and Denmark, Clinical Ink is rewriting the clinical development experience.
Job Description
Clinical Ink is seeking a Director, Enterprise AI Governance and Strategy to to join our AI Enablement team based in the United States. The Director, Enterprise AI Governance and Strategy leads Clinical Ink's AI governance program end to end - chairing our AI Governance Council, running the AI Champions Network, and serving as the operational owner of the SOP-AI suite. This role turns governance from a compliance checkbox into a living system: one that gives leadership, customers, and regulators confidence, while giving internal teams clear, usable guardrails instead of friction. The Director, Enterprise AI Governance and Strategy's responsibilities include but are not limited to:
- AI Governance, Principles & Risk Management
- Own and evolve Clinical Ink's AI governance framework and supporting standard operating procedures (SOP) suite, AI tools listing, ensuring they stay current with ISO 42001, EU AI Act, and relevant GxP requirements (21 CFR Part 11, Annex 11).
- Manage the associated SOP resources, e.g. AI System Management.
- Chair the AI Governance Council; drive intake, review, and approval of new AI use cases and tools.
- Partner with Legal, Regulatory Compliance, and other internal stakeholders to manage AI-related risk across sponsor contracts (MSA AI-data-rights clauses, disclosure obligations) and ensure governance steps are actually followed in practice, not just documented.
- Own sponsor- and regulator-facing AI disclosure and approval artifacts (e.g., pilot notices, technology disclosures).
- Leadership & Enablement Networks
- Direct the AI Governance Council and the AI Champions Network - setting agendas, driving decisions, and turning both into functioning operational bodies rather than standing meetings.
- Identify training gaps across the organization and ensure team members have access to the AI education and enablement they need to work safely and effectively with AI tools.
- Serve as the primary internal and external voice for "how Clinical Ink governs AI" - building and maintaining communication artifacts for leadership, sponsors, and prospective partners.
- Insights, Tooling & Oversight
- Own visibility into enterprise AI usage: token consumption, spend by team/product, model adoption trends, and emerging agentic workflow patterns.
- Translate usage data into decisions - flagging misuse, informing model-selection policy, and surfacing cost/ROI insights to leadership.
- Maintain the tools and reporting infrastructure that make this visibility possible (dashboards, usage reports, spend analysis).
- Manage registration and access to approved AI connectors/tools.
- Strategy & Cross-Functional Planning
- Partner with key AI Enablement team members on roadmapping and planning for AI&I team initiatives, ensuring governance and infrastructure priorities move in lockstep.
- Partner with the R&D Director to ensure the AI-SDLC is well-supported by governance processes, and that agentic strategy execution stays aligned with overall Enterprise AI strategy.
- Represent governance considerations in AI investment planning, M&A technical diligence, and connected-device/data-partner evaluations as needed.
Qualifications
- Bachelor's degree required; Master's degree or PhD in Computer Science, Statistics, AI/ML, or a related field preferred.
- 2+ years in technology governance, risk/compliance, or AI/data strategy roles, with at least 1–2 years focused specifically on AI governance or responsible AI programs.
- 8-10 years in technology innovation, including developing AI/ML models and/or contributing to or leading AI, data, or engineering teams and/or strategy.
- Experience in life sciences, clinical trials, or another GxP-regulated industry (21 CFR Part 11, GAMP 5, ICH E6) preferred.
- Demonstrated experience in awareness of, building or operating governance frameworks (e.g., NIST AI RMF, ISO 42001, EU AI Act) in a regulated or high-scrutiny environment.
- Experience running cross-functional councils or working groups - able to drive decisions, not just facilitate discussion.
- Strong ability to translate technical AI/ML concepts (model behavior, agentic workflows, token economics) into risk and business language for non-technical stakeholders.
- Comfortable working directly with Legal/Regulatory Compliance on contract language and disclosure obligations.
- Familiarity with enterprise LLM platforms (Anthropic Claude, AWS Bedrock, or similar) and usage/cost analytics preferred.
- Experience/awareness of deploying solutions to cloud environments (Amazon, Microsoft, Google, etc.) preferred.
- Experience supporting or governing agentic AI systems and SDLC processes for AI-assisted development preferred.
Additional Information
Clinical Ink is an equal opportunity employer and does not discriminate against otherwise qualified applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or handicap, or veteran status.
Personal data submitted in connection with this position will be processed by Clinical Ink Denmark ApS and Clinical Ink, Inc. for recruitment and hiring purposes. Paycor Recruiting is used to collect and manage applications; please review the Clinical Ink Privacy Policy and Paycor Privacy Policy for additional information. 
— Sarah J.
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Marketing Manager
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