Associate Director, Clinical Experience

Associate Director, Clinical Experience

LRL Grade: P4 - Location: Cork, Ireland - Function:

Role Purpose

As the Associate Director for Clinical Experience, you will provide strategic leadership across a broad portfolio of clinical technology solutions that directly shape how patients and providers engage with Lilly's clinical trials. You will lead a geographically distributed team and manage a portfolio of internal and externally delivered technology solutions in a GxP-regulated environment.

Key Responsibilities

1. eCOA Portfolio & External Vendor Oversight - Own the strategic direction and operational oversight of Electronic Clinical Outcome Assessment (eCOA) solutions across the clinical trial portfolio. Serve as the accountable IT lead for eCOA vendor relationships, including scope governance, performance management, and contract alignment. Ensure eCOA platforms meet GxP compliance, patient usability standards, and regulatory submission requirements (21CFR Part11 / EU Annex11). Partner with Clinical Operations, Biostatistics, and Regulatory to align eCOA strategy with study design and endpoint requirements. Drive continuous improvement across eCOA delivery including qualification, deployment, and support lifecycle management.
2. Patient Engagement Applications - Manage and support the portfolio of patient engagement applications used across decentralized and hybrid clinical trials. Lead product management activities for patient facing technologies including requirements definition, release planning, and user acceptance testing. Champion the patient and provider experience by embedding usability research and accessibility standards (WCAG2.2 / European Accessibility Act) into application design and delivery. Partner with clinical and technology teams to onboard and offboard participants to trial specific technologies seamlessly and compliantly. Monitor adoption, satisfaction, and operational performance of patient engagement platforms and drive improvement actions.
3. Vendor Management & Service Management - Drive vendor management across the clinical experience technology portfolio, including eCOA, patient engagement, and connected device vendors. Establish and maintain governance frameworks including SLAs, KPIs, and escalation pathways for all clinical technology vendors. Lead periodic vendor reviews, manage issue resolution, and ensure contractual obligations are met in partnership with Procurement and Legal. Accountable for end to end service management including incident management, problem management, and continuous service improvement in alignment with ITIL practices. Ensure supplier compliance with Lilly quality, security, and regulatory standards through regular audits and due diligence activities.
4. New Application Delivery - Accountable for the end to end delivery of new clinical applications from requirements through deployment and hyper care. Lead delivery planning, resource allocation, and milestone governance for new technology implementations within the clinical experience portfolio. Partner with Quality, Regulatory, and Validation teams to ensure all new applications are delivered in compliance with GxP/CSV requirements. Drive structured project delivery using agile and hybrid delivery methodologies, ensuring transparency with stakeholders throughout the lifecycle. Manage delivery risks, dependencies, and escalations, maintaining accountability for on time, on scope, and quality delivery outcomes.
5. AI Enablement for Clinical Experience - Lead the identification, evaluation, and adoption of AI and agentic capabilities to enhance the clinical experience for patients, providers, and operational teams. Define and execute an AI roadmap for clinical experience, prioritising use cases such as intelligent trial support, patient journey orchestration, and automated eCOA data quality. Partner with Lilly's enterprise AI platforms and external partners to prototype, validate, and deploy AI solutions in a GxP compliant manner. Ensure responsible AI governance is embedded in all clinical AI initiatives, including data privacy, auditability, and regulatory alignment. Build AI literacy within the clinical experience team and with business stakeholders, fostering a culture of innovation grounded in patient safety.
6. Collaborate & Drive Operations - Build deep clinical trial operations knowledge and strong relationships with Medicines Development, Clinical Operations, and Quality stakeholders. Work closely with trial capability leads and clinical trial project managers to ensure traditional and non traditional technology needs are met across the portfolio. Manage and resolve issues raised by end users and business partners with related vendors; maintain robust issue logging and knowledge management in ServiceNow. Partner on audit readiness, Periodic Reviews, and CAPA activities related to clinical technology systems.
7. People Leadership & Team Development - Lead and develop a geographically distributed team across multiple sites, fostering a high performance, inclusive culture. Set clear objectives, provide regular coaching, and support career development for direct and indirect reports. Build capability in the team across clinical technology, AI, vendor management, and GxP compliance. Model Lilly leadership behaviours and actively contribute to a diverse, equitable, and inclusive work environment.
8. Iterate & Innovate - Capture and prioritise requirements needed for continuous improvement of clinical capabilities. Collaborate with associated technical delivery teams to drive completion of innovation requirements. Engage with external organisations and industry bodies to bring industry standard methodology back into Lilly and forge new operational processes.

Required Skills and Experience

• Bachelor's degree or higher in Computer Science, Information Systems, Life Sciences, or a related field.
• Significant experience in clinical technology delivery, pharmaceutical IT, or a regulated life sciences environment.
• Demonstrated experience managing eCOA or patient facing clinical technology solutions.
• Proven track record of vendor management and service delivery accountability in a GxP or regulated context.
• Experience delivering new technology applications end to end, including validation and compliance activities (21CFR Part11 / EU Annex11 / GAMP5).
• Strong leadership capability with experience managing distributed teams and cross functional stakeholders.

Preferred Skills and Experience

• Familiarity with AI/ML platforms and experience scoping or delivering AI enabled clinical solutions.
• ITIL Foundation certification or above.
• Experience with eCOA platforms such as Medidata Rave, Veeva Vault eCOA, Aparito Atom5, Clario, or equivalent.
• Knowledge of decentralized clinical trial (DCT) capabilities including connected devices, eConsent, and remote monitoring technologies.
• Agile or hybrid delivery experience; familiarity with tools such as Jira, ServiceNow, Smartsheet, or MS Project.
• Experience with accessibility standards (WCAG2.2 / European Accessibility Act).
• Demonstrated ability to translate technical concepts into business language for non IDS stakeholders.
• Strong negotiation, communication, and interpersonal skills with the ability to influence at senior levels.
• Experience with SAFe or PI Planning in a large enterprise environment.

Equal Employment Opportunity Statement

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. We are committed to helping individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources () for further assistance.